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idK170974_s0_e2000 | K170974.txt | classification | Class II | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K170974 B. Purpose for Submission: New device C. Manufacturer and Instrument Name: BD Biosciences BD FACSLyric Flow Cytometer (3−1, 4−2, 4−2−2 and 4−3−3 optical configurations) with BD FACSuite Clinical Software D. Type of Test or Tests Performed: Quantitative and Semi-quantitative Flow Cytometric Immunoassays E. Systems Description: 1. Device Description: The BD FACSLyric™ flow cytometer (3−1, 4−2, 4−2−2, and 4−3−3 optical configurations) systems consist of a flow cytometer, sheath tank, waste tank, and a computer workstation. System options include an automated FACS Universal Loader and a barcode reader. The BD FACSLyric Flow Cytometer includes the 488 nm laser and 640 nm laser as part of four available manufactured instrument configurations. BD FACSLyric Flow Cytometer, 3−1 configuration, 4-color/2-laser BD FACSLyric Flow Cytometer, 4−2 configuration, 6-color/2-laser BD FACSLyric Flow Cytometer, 4−2−2 configuration, 8-color/3-laser BD FACSLyric Flow Cytometer, 4−3−3 configuration, 10-color/3-laser The lower level configurations are upgradeable to higher level configurations by adding filters, photomultiplier tubes (PMTs), and a laser. Only the 488 nm laser and 640 nm lasers are utilized for cleared in vitro diagnostic (IVD) applications and only fluorescence channels 1 (FL1) through FL6 are the subject of this 510(k) submission. Seven to ten-
color immunophenotyping is for research use only (RUO). All optical configurations of the FACSLyric share the same dimensions: 22.8 inches in height by 24.93 inches in width by 22.8 inches in depth. 2
Accessory Reagents BD™ FC beads 7-color kit: used to establish fluorescence compensation on the flow cytometer. BD™ CS&T beads: used for the quality control of optics, electronics, and fluidics, and for adjusting detector voltages and fluorescence compensation on the flow cytometer. BD Trucount™ tubes: used to determine absolute counts of leucocytes in erythrocyte-
lysed whole blood. Optional BD FACS™ Universal Loader 2. Principles of Operation: Flow cytometers combine fluidics, optics, and electronics subsystems to measure and analyze signals emitted when particles in a liquid stream flow through a glass cuvette at which beams of laser light are directed. The scatter and fluorescence light signals from these particles provide information about cell size, internal complexity, and relative fluorescence intensity. The Instructions for Use for each BD FACSLyric instrument includes details on the system components and theory of operations. The instruments are intended for use with cleared or approved in vitro diagnostic (IVD) assays for the identification and enumeration of human cell subsets that are indicated for use with the instrument. 3. Modes of Operation: Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? Yes ____X____ or No ________ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes ____X____ or No ________ 4. Specimen Identification: Barcode reader or manual entry 5. Specimen Sampling and Handling: The instruments may be used with or without the BD FACS Sample Prep Assistant III. Specimen handling should be performed according to the IVD assay intended for use 3
with the instruments. 6. Calibration: Calibration is performed with the IVD assay intended for use with the instruments. 7. Quality Control: Quality control is performed with the IVD assay intended for use with the instruments. 8. Software: FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types: Yes _____X___ or No ________ F. Regulatory Information: 1. Regulation section: 21 CFR §864.5220, Automated Differential Cell Counter 2. Classification: Class II 3. Product code: OYE, flow cytometric reagents and accessories 4. Panel: Hematology (81) G. Intended Use: 1. Indication(s) for use: The BD FACSLyric™ flow cytometer is intended for use as an in vitro diagnostic device for immunophenotyping using up to six fluorescence detection channels and two light scatter channels using a blue (488-nm) and a red (640-nm) laser. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument. BD Multitest™ 6-color TBNK, BD Multitest™ IMK kit, BD Multitest™ CD3/CD8/CD45/CD4, and BD Multitest™ CD3/CD16+CD56/CD45/CD19, all with 4
optional BD Trucount™ tubes, are intended for use on the BD FACSLyric flow cytometer with peripheral whole blood for immunophenotyping. These reagents are indicated for use in the immunological assessment of normal individuals, and patients having, or suspected of having, immune deficiency. These reagents determine the percentages and absolute counts of the following mature human lymphocyte subsets: BD Multitest 6-color TBNK with optional BD Trucount tubes • T lymphocytes (CD3+) • B lymphocytes (CD19+) • Natural killer (NK) lymphocytes (CD3–CD16+ and/or CD56+) • Helper/inducer T lymphocytes (CD3+CD4+) • Suppressor/cytotoxic T lymphocytes (CD3+CD8+) BD Multitest IMK kit with optional BD Trucount tubes • T lymphocytes (CD3+) • B lymphocytes (CD19+) • Natural killer (NK) lymphocytes (CD3–CD16+ and/or CD56+) • Helper/inducer T lymphocytes (CD3+CD4+) • Suppressor/cytotoxic T lymphocytes (CD3+CD8+) BD Multitest CD3/CD8/CD45/CD4 with optional BD Trucount tubes • T lymphocytes (CD3+) • Suppressor/cytotoxic T lymphocytes (CD3+CD8+) • Helper/inducer T lymphocytes (CD3+CD4+) BD Multitest CD3/CD16+CD56/CD45/CD19 with optional BD Trucount tubes • T lymphocytes (CD3+) • Natural killer (NK) lymphocytes (CD3–CD16+ and/or CD56+) • B lymphocytes (CD3–CD19+) 2. Special conditions for use statement(s): For Prescription Use Only H. Substantial Equivalence Information: 1. Predicate device names: BD FACSCanto II (4-2-2 and 5-3 configurations); BD FACSCanto II (4-2 configuration); BD Multitest CD3/CD16+56/CD45/CD19 and BD Multitest IMK Kit; BD Multitest CD3/CD8/CD45/CD4; BD Multitest 6-color TBNK; BD FACS 7-Color Setup Beads; BD Multi-Check Control; BD Multi-Check CD4 Low Control; BD Trucount Tubes 2. Predicate 510(k) numbers: K141468; K062087; K980858; K974360; K090967; K040026; K961610; K982231; K970836 5
3. Comparison with predicate: Similarities Item New device BD FACSLyric 3-1, 4-2, 4-2-2 and 4-3-3 Configurations Predicate BD FACSCanto II 4-2-2 Configuration Intended Use The BD FACSLyric™ flow cytometer is intended for use as an in vitro diagnostic device for immunophenotyping using up to six fluorescence detection channels and two light scatter channels using a blue (488-
nm) and a red (640-nm) laser. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument. The BD FACSCanto™ II flow cytometers (4-2-2 and 5-3 configurations) function as part of a system with dedicated clinical software intended for use with cleared or approved in vitro diagnostic (IVD) assays that are indicated for use with the instrument for the identification and enumeration of human cell subsets. Only six detection channels using a blue (488 nm) and a red (633 nm) laser have been cleared for in vitro diagnostic use. For use with or without the BD FACS Sample Prep Assistant III. Forward Scatter Detection Photodiode with built-in 488/10 bandpass filter Same IVD Lasers/Excitation Blue Laser: Blue/488 nm, 20mW Same Fluorescence and Side Scatter Detection Side scatter and fluorescence · Reflective optics with single transmission bandpass filter in front of each PMT · High
Classification: |
idK170974_s0_e2000 | K170974.txt | product code | OYE, flow cytometric reagents and accessories | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K170974 B. Purpose for Submission: New device C. Manufacturer and Instrument Name: BD Biosciences BD FACSLyric Flow Cytometer (3−1, 4−2, 4−2−2 and 4−3−3 optical configurations) with BD FACSuite Clinical Software D. Type of Test or Tests Performed: Quantitative and Semi-quantitative Flow Cytometric Immunoassays E. Systems Description: 1. Device Description: The BD FACSLyric™ flow cytometer (3−1, 4−2, 4−2−2, and 4−3−3 optical configurations) systems consist of a flow cytometer, sheath tank, waste tank, and a computer workstation. System options include an automated FACS Universal Loader and a barcode reader. The BD FACSLyric Flow Cytometer includes the 488 nm laser and 640 nm laser as part of four available manufactured instrument configurations. BD FACSLyric Flow Cytometer, 3−1 configuration, 4-color/2-laser BD FACSLyric Flow Cytometer, 4−2 configuration, 6-color/2-laser BD FACSLyric Flow Cytometer, 4−2−2 configuration, 8-color/3-laser BD FACSLyric Flow Cytometer, 4−3−3 configuration, 10-color/3-laser The lower level configurations are upgradeable to higher level configurations by adding filters, photomultiplier tubes (PMTs), and a laser. Only the 488 nm laser and 640 nm lasers are utilized for cleared in vitro diagnostic (IVD) applications and only fluorescence channels 1 (FL1) through FL6 are the subject of this 510(k) submission. Seven to ten-
color immunophenotyping is for research use only (RUO). All optical configurations of the FACSLyric share the same dimensions: 22.8 inches in height by 24.93 inches in width by 22.8 inches in depth. 2
Accessory Reagents BD™ FC beads 7-color kit: used to establish fluorescence compensation on the flow cytometer. BD™ CS&T beads: used for the quality control of optics, electronics, and fluidics, and for adjusting detector voltages and fluorescence compensation on the flow cytometer. BD Trucount™ tubes: used to determine absolute counts of leucocytes in erythrocyte-
lysed whole blood. Optional BD FACS™ Universal Loader 2. Principles of Operation: Flow cytometers combine fluidics, optics, and electronics subsystems to measure and analyze signals emitted when particles in a liquid stream flow through a glass cuvette at which beams of laser light are directed. The scatter and fluorescence light signals from these particles provide information about cell size, internal complexity, and relative fluorescence intensity. The Instructions for Use for each BD FACSLyric instrument includes details on the system components and theory of operations. The instruments are intended for use with cleared or approved in vitro diagnostic (IVD) assays for the identification and enumeration of human cell subsets that are indicated for use with the instrument. 3. Modes of Operation: Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? Yes ____X____ or No ________ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes ____X____ or No ________ 4. Specimen Identification: Barcode reader or manual entry 5. Specimen Sampling and Handling: The instruments may be used with or without the BD FACS Sample Prep Assistant III. Specimen handling should be performed according to the IVD assay intended for use 3
with the instruments. 6. Calibration: Calibration is performed with the IVD assay intended for use with the instruments. 7. Quality Control: Quality control is performed with the IVD assay intended for use with the instruments. 8. Software: FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types: Yes _____X___ or No ________ F. Regulatory Information: 1. Regulation section: 21 CFR §864.5220, Automated Differential Cell Counter 2. Classification: Class II 3. Product code: OYE, flow cytometric reagents and accessories 4. Panel: Hematology (81) G. Intended Use: 1. Indication(s) for use: The BD FACSLyric™ flow cytometer is intended for use as an in vitro diagnostic device for immunophenotyping using up to six fluorescence detection channels and two light scatter channels using a blue (488-nm) and a red (640-nm) laser. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument. BD Multitest™ 6-color TBNK, BD Multitest™ IMK kit, BD Multitest™ CD3/CD8/CD45/CD4, and BD Multitest™ CD3/CD16+CD56/CD45/CD19, all with 4
optional BD Trucount™ tubes, are intended for use on the BD FACSLyric flow cytometer with peripheral whole blood for immunophenotyping. These reagents are indicated for use in the immunological assessment of normal individuals, and patients having, or suspected of having, immune deficiency. These reagents determine the percentages and absolute counts of the following mature human lymphocyte subsets: BD Multitest 6-color TBNK with optional BD Trucount tubes • T lymphocytes (CD3+) • B lymphocytes (CD19+) • Natural killer (NK) lymphocytes (CD3–CD16+ and/or CD56+) • Helper/inducer T lymphocytes (CD3+CD4+) • Suppressor/cytotoxic T lymphocytes (CD3+CD8+) BD Multitest IMK kit with optional BD Trucount tubes • T lymphocytes (CD3+) • B lymphocytes (CD19+) • Natural killer (NK) lymphocytes (CD3–CD16+ and/or CD56+) • Helper/inducer T lymphocytes (CD3+CD4+) • Suppressor/cytotoxic T lymphocytes (CD3+CD8+) BD Multitest CD3/CD8/CD45/CD4 with optional BD Trucount tubes • T lymphocytes (CD3+) • Suppressor/cytotoxic T lymphocytes (CD3+CD8+) • Helper/inducer T lymphocytes (CD3+CD4+) BD Multitest CD3/CD16+CD56/CD45/CD19 with optional BD Trucount tubes • T lymphocytes (CD3+) • Natural killer (NK) lymphocytes (CD3–CD16+ and/or CD56+) • B lymphocytes (CD3–CD19+) 2. Special conditions for use statement(s): For Prescription Use Only H. Substantial Equivalence Information: 1. Predicate device names: BD FACSCanto II (4-2-2 and 5-3 configurations); BD FACSCanto II (4-2 configuration); BD Multitest CD3/CD16+56/CD45/CD19 and BD Multitest IMK Kit; BD Multitest CD3/CD8/CD45/CD4; BD Multitest 6-color TBNK; BD FACS 7-Color Setup Beads; BD Multi-Check Control; BD Multi-Check CD4 Low Control; BD Trucount Tubes 2. Predicate 510(k) numbers: K141468; K062087; K980858; K974360; K090967; K040026; K961610; K982231; K970836 5
3. Comparison with predicate: Similarities Item New device BD FACSLyric 3-1, 4-2, 4-2-2 and 4-3-3 Configurations Predicate BD FACSCanto II 4-2-2 Configuration Intended Use The BD FACSLyric™ flow cytometer is intended for use as an in vitro diagnostic device for immunophenotyping using up to six fluorescence detection channels and two light scatter channels using a blue (488-
nm) and a red (640-nm) laser. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument. The BD FACSCanto™ II flow cytometers (4-2-2 and 5-3 configurations) function as part of a system with dedicated clinical software intended for use with cleared or approved in vitro diagnostic (IVD) assays that are indicated for use with the instrument for the identification and enumeration of human cell subsets. Only six detection channels using a blue (488 nm) and a red (633 nm) laser have been cleared for in vitro diagnostic use. For use with or without the BD FACS Sample Prep Assistant III. Forward Scatter Detection Photodiode with built-in 488/10 bandpass filter Same IVD Lasers/Excitation Blue Laser: Blue/488 nm, 20mW Same Fluorescence and Side Scatter Detection Side scatter and fluorescence · Reflective optics with single transmission bandpass filter in front of each PMT · High
Product code: |
idK170974_s0_e2000 | K170974.txt | panel | Hematology (81) | (k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K170974 B. Purpose for Submission: New device C. Manufacturer and Instrument Name: BD Biosciences BD FACSLyric Flow Cytometer (3−1, 4−2, 4−2−2 and 4−3−3 optical configurations) with BD FACSuite Clinical Software D. Type of Test or Tests Performed: Quantitative and Semi-quantitative Flow Cytometric Immunoassays E. Systems Description: 1. Device Description: The BD FACSLyric™ flow cytometer (3−1, 4−2, 4−2−2, and 4−3−3 optical configurations) systems consist of a flow cytometer, sheath tank, waste tank, and a computer workstation. System options include an automated FACS Universal Loader and a barcode reader. The BD FACSLyric Flow Cytometer includes the 488 nm laser and 640 nm laser as part of four available manufactured instrument configurations. BD FACSLyric Flow Cytometer, 3−1 configuration, 4-color/2-laser BD FACSLyric Flow Cytometer, 4−2 configuration, 6-color/2-laser BD FACSLyric Flow Cytometer, 4−2−2 configuration, 8-color/3-laser BD FACSLyric Flow Cytometer, 4−3−3 configuration, 10-color/3-laser The lower level configurations are upgradeable to higher level configurations by adding filters, photomultiplier tubes (PMTs), and a laser. Only the 488 nm laser and 640 nm lasers are utilized for cleared in vitro diagnostic (IVD) applications and only fluorescence channels 1 (FL1) through FL6 are the subject of this 510(k) submission. Seven to ten-
color immunophenotyping is for research use only (RUO). All optical configurations of the FACSLyric share the same dimensions: 22.8 inches in height by 24.93 inches in width by 22.8 inches in depth. 2
Accessory Reagents BD™ FC beads 7-color kit: used to establish fluorescence compensation on the flow cytometer. BD™ CS&T beads: used for the quality control of optics, electronics, and fluidics, and for adjusting detector voltages and fluorescence compensation on the flow cytometer. BD Trucount™ tubes: used to determine absolute counts of leucocytes in erythrocyte-
lysed whole blood. Optional BD FACS™ Universal Loader 2. Principles of Operation: Flow cytometers combine fluidics, optics, and electronics subsystems to measure and analyze signals emitted when particles in a liquid stream flow through a glass cuvette at which beams of laser light are directed. The scatter and fluorescence light signals from these particles provide information about cell size, internal complexity, and relative fluorescence intensity. The Instructions for Use for each BD FACSLyric instrument includes details on the system components and theory of operations. The instruments are intended for use with cleared or approved in vitro diagnostic (IVD) assays for the identification and enumeration of human cell subsets that are indicated for use with the instrument. 3. Modes of Operation: Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? Yes ____X____ or No ________ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes ____X____ or No ________ 4. Specimen Identification: Barcode reader or manual entry 5. Specimen Sampling and Handling: The instruments may be used with or without the BD FACS Sample Prep Assistant III. Specimen handling should be performed according to the IVD assay intended for use 3
with the instruments. 6. Calibration: Calibration is performed with the IVD assay intended for use with the instruments. 7. Quality Control: Quality control is performed with the IVD assay intended for use with the instruments. 8. Software: FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types: Yes _____X___ or No ________ F. Regulatory Information: 1. Regulation section: 21 CFR §864.5220, Automated Differential Cell Counter 2. Classification: Class II 3. Product code: OYE, flow cytometric reagents and accessories 4. Panel: Hematology (81) G. Intended Use: 1. Indication(s) for use: The BD FACSLyric™ flow cytometer is intended for use as an in vitro diagnostic device for immunophenotyping using up to six fluorescence detection channels and two light scatter channels using a blue (488-nm) and a red (640-nm) laser. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument. BD Multitest™ 6-color TBNK, BD Multitest™ IMK kit, BD Multitest™ CD3/CD8/CD45/CD4, and BD Multitest™ CD3/CD16+CD56/CD45/CD19, all with 4
optional BD Trucount™ tubes, are intended for use on the BD FACSLyric flow cytometer with peripheral whole blood for immunophenotyping. These reagents are indicated for use in the immunological assessment of normal individuals, and patients having, or suspected of having, immune deficiency. These reagents determine the percentages and absolute counts of the following mature human lymphocyte subsets: BD Multitest 6-color TBNK with optional BD Trucount tubes • T lymphocytes (CD3+) • B lymphocytes (CD19+) • Natural killer (NK) lymphocytes (CD3–CD16+ and/or CD56+) • Helper/inducer T lymphocytes (CD3+CD4+) • Suppressor/cytotoxic T lymphocytes (CD3+CD8+) BD Multitest IMK kit with optional BD Trucount tubes • T lymphocytes (CD3+) • B lymphocytes (CD19+) • Natural killer (NK) lymphocytes (CD3–CD16+ and/or CD56+) • Helper/inducer T lymphocytes (CD3+CD4+) • Suppressor/cytotoxic T lymphocytes (CD3+CD8+) BD Multitest CD3/CD8/CD45/CD4 with optional BD Trucount tubes • T lymphocytes (CD3+) • Suppressor/cytotoxic T lymphocytes (CD3+CD8+) • Helper/inducer T lymphocytes (CD3+CD4+) BD Multitest CD3/CD16+CD56/CD45/CD19 with optional BD Trucount tubes • T lymphocytes (CD3+) • Natural killer (NK) lymphocytes (CD3–CD16+ and/or CD56+) • B lymphocytes (CD3–CD19+) 2. Special conditions for use statement(s): For Prescription Use Only H. Substantial Equivalence Information: 1. Predicate device names: BD FACSCanto II (4-2-2 and 5-3 configurations); BD FACSCanto II (4-2 configuration); BD Multitest CD3/CD16+56/CD45/CD19 and BD Multitest IMK Kit; BD Multitest CD3/CD8/CD45/CD4; BD Multitest 6-color TBNK; BD FACS 7-Color Setup Beads; BD Multi-Check Control; BD Multi-Check CD4 Low Control; BD Trucount Tubes 2. Predicate 510(k) numbers: K141468; K062087; K980858; K974360; K090967; K040026; K961610; K982231; K970836 5
3. Comparison with predicate: Similarities Item New device BD FACSLyric 3-1, 4-2, 4-2-2 and 4-3-3 Configurations Predicate BD FACSCanto II 4-2-2 Configuration Intended Use The BD FACSLyric™ flow cytometer is intended for use as an in vitro diagnostic device for immunophenotyping using up to six fluorescence detection channels and two light scatter channels using a blue (488-
nm) and a red (640-nm) laser. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument. The BD FACSCanto™ II flow cytometers (4-2-2 and 5-3 configurations) function as part of a system with dedicated clinical software intended for use with cleared or approved in vitro diagnostic (IVD) assays that are indicated for use with the instrument for the identification and enumeration of human cell subsets. Only six detection channels using a blue (488 nm) and a red (633 nm) laser have been cleared for in vitro diagnostic use. For use with or without the BD FACS Sample Prep Assistant III. Forward Scatter Detection Photodiode with built-in 488/10 bandpass filter Same IVD Lasers/Excitation Blue Laser: Blue/488 nm, 20mW Same Fluorescence and Side Scatter Detection Side scatter and fluorescence · Reflective optics with single transmission bandpass filter in front of each PMT · High
Panel: |
idK170974_s0_e2000 | K170974.txt | applicant | BD Biosciences | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K170974 B. Purpose for Submission: New device C. Manufacturer and Instrument Name: BD Biosciences BD FACSLyric Flow Cytometer (3−1, 4−2, 4−2−2 and 4−3−3 optical configurations) with BD FACSuite Clinical Software D. Type of Test or Tests Performed: Quantitative and Semi-quantitative Flow Cytometric Immunoassays E. Systems Description: 1. Device Description: The BD FACSLyric™ flow cytometer (3−1, 4−2, 4−2−2, and 4−3−3 optical configurations) systems consist of a flow cytometer, sheath tank, waste tank, and a computer workstation. System options include an automated FACS Universal Loader and a barcode reader. The BD FACSLyric Flow Cytometer includes the 488 nm laser and 640 nm laser as part of four available manufactured instrument configurations. BD FACSLyric Flow Cytometer, 3−1 configuration, 4-color/2-laser BD FACSLyric Flow Cytometer, 4−2 configuration, 6-color/2-laser BD FACSLyric Flow Cytometer, 4−2−2 configuration, 8-color/3-laser BD FACSLyric Flow Cytometer, 4−3−3 configuration, 10-color/3-laser The lower level configurations are upgradeable to higher level configurations by adding filters, photomultiplier tubes (PMTs), and a laser. Only the 488 nm laser and 640 nm lasers are utilized for cleared in vitro diagnostic (IVD) applications and only fluorescence channels 1 (FL1) through FL6 are the subject of this 510(k) submission. Seven to ten-
color immunophenotyping is for research use only (RUO). All optical configurations of the FACSLyric share the same dimensions: 22.8 inches in height by 24.93 inches in width by 22.8 inches in depth. 2
Accessory Reagents BD™ FC beads 7-color kit: used to establish fluorescence compensation on the flow cytometer. BD™ CS&T beads: used for the quality control of optics, electronics, and fluidics, and for adjusting detector voltages and fluorescence compensation on the flow cytometer. BD Trucount™ tubes: used to determine absolute counts of leucocytes in erythrocyte-
lysed whole blood. Optional BD FACS™ Universal Loader 2. Principles of Operation: Flow cytometers combine fluidics, optics, and electronics subsystems to measure and analyze signals emitted when particles in a liquid stream flow through a glass cuvette at which beams of laser light are directed. The scatter and fluorescence light signals from these particles provide information about cell size, internal complexity, and relative fluorescence intensity. The Instructions for Use for each BD FACSLyric instrument includes details on the system components and theory of operations. The instruments are intended for use with cleared or approved in vitro diagnostic (IVD) assays for the identification and enumeration of human cell subsets that are indicated for use with the instrument. 3. Modes of Operation: Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? Yes ____X____ or No ________ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes ____X____ or No ________ 4. Specimen Identification: Barcode reader or manual entry 5. Specimen Sampling and Handling: The instruments may be used with or without the BD FACS Sample Prep Assistant III. Specimen handling should be performed according to the IVD assay intended for use 3
with the instruments. 6. Calibration: Calibration is performed with the IVD assay intended for use with the instruments. 7. Quality Control: Quality control is performed with the IVD assay intended for use with the instruments. 8. Software: FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types: Yes _____X___ or No ________ F. Regulatory Information: 1. Regulation section: 21 CFR §864.5220, Automated Differential Cell Counter 2. Classification: Class II 3. Product code: OYE, flow cytometric reagents and accessories 4. Panel: Hematology (81) G. Intended Use: 1. Indication(s) for use: The BD FACSLyric™ flow cytometer is intended for use as an in vitro diagnostic device for immunophenotyping using up to six fluorescence detection channels and two light scatter channels using a blue (488-nm) and a red (640-nm) laser. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument. BD Multitest™ 6-color TBNK, BD Multitest™ IMK kit, BD Multitest™ CD3/CD8/CD45/CD4, and BD Multitest™ CD3/CD16+CD56/CD45/CD19, all with 4
optional BD Trucount™ tubes, are intended for use on the BD FACSLyric flow cytometer with peripheral whole blood for immunophenotyping. These reagents are indicated for use in the immunological assessment of normal individuals, and patients having, or suspected of having, immune deficiency. These reagents determine the percentages and absolute counts of the following mature human lymphocyte subsets: BD Multitest 6-color TBNK with optional BD Trucount tubes • T lymphocytes (CD3+) • B lymphocytes (CD19+) • Natural killer (NK) lymphocytes (CD3–CD16+ and/or CD56+) • Helper/inducer T lymphocytes (CD3+CD4+) • Suppressor/cytotoxic T lymphocytes (CD3+CD8+) BD Multitest IMK kit with optional BD Trucount tubes • T lymphocytes (CD3+) • B lymphocytes (CD19+) • Natural killer (NK) lymphocytes (CD3–CD16+ and/or CD56+) • Helper/inducer T lymphocytes (CD3+CD4+) • Suppressor/cytotoxic T lymphocytes (CD3+CD8+) BD Multitest CD3/CD8/CD45/CD4 with optional BD Trucount tubes • T lymphocytes (CD3+) • Suppressor/cytotoxic T lymphocytes (CD3+CD8+) • Helper/inducer T lymphocytes (CD3+CD4+) BD Multitest CD3/CD16+CD56/CD45/CD19 with optional BD Trucount tubes • T lymphocytes (CD3+) • Natural killer (NK) lymphocytes (CD3–CD16+ and/or CD56+) • B lymphocytes (CD3–CD19+) 2. Special conditions for use statement(s): For Prescription Use Only H. Substantial Equivalence Information: 1. Predicate device names: BD FACSCanto II (4-2-2 and 5-3 configurations); BD FACSCanto II (4-2 configuration); BD Multitest CD3/CD16+56/CD45/CD19 and BD Multitest IMK Kit; BD Multitest CD3/CD8/CD45/CD4; BD Multitest 6-color TBNK; BD FACS 7-Color Setup Beads; BD Multi-Check Control; BD Multi-Check CD4 Low Control; BD Trucount Tubes 2. Predicate 510(k) numbers: K141468; K062087; K980858; K974360; K090967; K040026; K961610; K982231; K970836 5
3. Comparison with predicate: Similarities Item New device BD FACSLyric 3-1, 4-2, 4-2-2 and 4-3-3 Configurations Predicate BD FACSCanto II 4-2-2 Configuration Intended Use The BD FACSLyric™ flow cytometer is intended for use as an in vitro diagnostic device for immunophenotyping using up to six fluorescence detection channels and two light scatter channels using a blue (488-
nm) and a red (640-nm) laser. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument. The BD FACSCanto™ II flow cytometers (4-2-2 and 5-3 configurations) function as part of a system with dedicated clinical software intended for use with cleared or approved in vitro diagnostic (IVD) assays that are indicated for use with the instrument for the identification and enumeration of human cell subsets. Only six detection channels using a blue (488 nm) and a red (633 nm) laser have been cleared for in vitro diagnostic use. For use with or without the BD FACS Sample Prep Assistant III. Forward Scatter Detection Photodiode with built-in 488/10 bandpass filter Same IVD Lasers/Excitation Blue Laser: Blue/488 nm, 20mW Same Fluorescence and Side Scatter Detection Side scatter and fluorescence · Reflective optics with single transmission bandpass filter in front of each PMT · High
Applicant: |
idK170974_s0_e2000 | K170974.txt | regulation section | 21 CFR §864.5220, Automated Differential Cell Counter | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K170974 B. Purpose for Submission: New device C. Manufacturer and Instrument Name: BD Biosciences BD FACSLyric Flow Cytometer (3−1, 4−2, 4−2−2 and 4−3−3 optical configurations) with BD FACSuite Clinical Software D. Type of Test or Tests Performed: Quantitative and Semi-quantitative Flow Cytometric Immunoassays E. Systems Description: 1. Device Description: The BD FACSLyric™ flow cytometer (3−1, 4−2, 4−2−2, and 4−3−3 optical configurations) systems consist of a flow cytometer, sheath tank, waste tank, and a computer workstation. System options include an automated FACS Universal Loader and a barcode reader. The BD FACSLyric Flow Cytometer includes the 488 nm laser and 640 nm laser as part of four available manufactured instrument configurations. BD FACSLyric Flow Cytometer, 3−1 configuration, 4-color/2-laser BD FACSLyric Flow Cytometer, 4−2 configuration, 6-color/2-laser BD FACSLyric Flow Cytometer, 4−2−2 configuration, 8-color/3-laser BD FACSLyric Flow Cytometer, 4−3−3 configuration, 10-color/3-laser The lower level configurations are upgradeable to higher level configurations by adding filters, photomultiplier tubes (PMTs), and a laser. Only the 488 nm laser and 640 nm lasers are utilized for cleared in vitro diagnostic (IVD) applications and only fluorescence channels 1 (FL1) through FL6 are the subject of this 510(k) submission. Seven to ten-
color immunophenotyping is for research use only (RUO). All optical configurations of the FACSLyric share the same dimensions: 22.8 inches in height by 24.93 inches in width by 22.8 inches in depth. 2
Accessory Reagents BD™ FC beads 7-color kit: used to establish fluorescence compensation on the flow cytometer. BD™ CS&T beads: used for the quality control of optics, electronics, and fluidics, and for adjusting detector voltages and fluorescence compensation on the flow cytometer. BD Trucount™ tubes: used to determine absolute counts of leucocytes in erythrocyte-
lysed whole blood. Optional BD FACS™ Universal Loader 2. Principles of Operation: Flow cytometers combine fluidics, optics, and electronics subsystems to measure and analyze signals emitted when particles in a liquid stream flow through a glass cuvette at which beams of laser light are directed. The scatter and fluorescence light signals from these particles provide information about cell size, internal complexity, and relative fluorescence intensity. The Instructions for Use for each BD FACSLyric instrument includes details on the system components and theory of operations. The instruments are intended for use with cleared or approved in vitro diagnostic (IVD) assays for the identification and enumeration of human cell subsets that are indicated for use with the instrument. 3. Modes of Operation: Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? Yes ____X____ or No ________ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes ____X____ or No ________ 4. Specimen Identification: Barcode reader or manual entry 5. Specimen Sampling and Handling: The instruments may be used with or without the BD FACS Sample Prep Assistant III. Specimen handling should be performed according to the IVD assay intended for use 3
with the instruments. 6. Calibration: Calibration is performed with the IVD assay intended for use with the instruments. 7. Quality Control: Quality control is performed with the IVD assay intended for use with the instruments. 8. Software: FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types: Yes _____X___ or No ________ F. Regulatory Information: 1. Regulation section: 21 CFR §864.5220, Automated Differential Cell Counter 2. Classification: Class II 3. Product code: OYE, flow cytometric reagents and accessories 4. Panel: Hematology (81) G. Intended Use: 1. Indication(s) for use: The BD FACSLyric™ flow cytometer is intended for use as an in vitro diagnostic device for immunophenotyping using up to six fluorescence detection channels and two light scatter channels using a blue (488-nm) and a red (640-nm) laser. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument. BD Multitest™ 6-color TBNK, BD Multitest™ IMK kit, BD Multitest™ CD3/CD8/CD45/CD4, and BD Multitest™ CD3/CD16+CD56/CD45/CD19, all with 4
optional BD Trucount™ tubes, are intended for use on the BD FACSLyric flow cytometer with peripheral whole blood for immunophenotyping. These reagents are indicated for use in the immunological assessment of normal individuals, and patients having, or suspected of having, immune deficiency. These reagents determine the percentages and absolute counts of the following mature human lymphocyte subsets: BD Multitest 6-color TBNK with optional BD Trucount tubes • T lymphocytes (CD3+) • B lymphocytes (CD19+) • Natural killer (NK) lymphocytes (CD3–CD16+ and/or CD56+) • Helper/inducer T lymphocytes (CD3+CD4+) • Suppressor/cytotoxic T lymphocytes (CD3+CD8+) BD Multitest IMK kit with optional BD Trucount tubes • T lymphocytes (CD3+) • B lymphocytes (CD19+) • Natural killer (NK) lymphocytes (CD3–CD16+ and/or CD56+) • Helper/inducer T lymphocytes (CD3+CD4+) • Suppressor/cytotoxic T lymphocytes (CD3+CD8+) BD Multitest CD3/CD8/CD45/CD4 with optional BD Trucount tubes • T lymphocytes (CD3+) • Suppressor/cytotoxic T lymphocytes (CD3+CD8+) • Helper/inducer T lymphocytes (CD3+CD4+) BD Multitest CD3/CD16+CD56/CD45/CD19 with optional BD Trucount tubes • T lymphocytes (CD3+) • Natural killer (NK) lymphocytes (CD3–CD16+ and/or CD56+) • B lymphocytes (CD3–CD19+) 2. Special conditions for use statement(s): For Prescription Use Only H. Substantial Equivalence Information: 1. Predicate device names: BD FACSCanto II (4-2-2 and 5-3 configurations); BD FACSCanto II (4-2 configuration); BD Multitest CD3/CD16+56/CD45/CD19 and BD Multitest IMK Kit; BD Multitest CD3/CD8/CD45/CD4; BD Multitest 6-color TBNK; BD FACS 7-Color Setup Beads; BD Multi-Check Control; BD Multi-Check CD4 Low Control; BD Trucount Tubes 2. Predicate 510(k) numbers: K141468; K062087; K980858; K974360; K090967; K040026; K961610; K982231; K970836 5
3. Comparison with predicate: Similarities Item New device BD FACSLyric 3-1, 4-2, 4-2-2 and 4-3-3 Configurations Predicate BD FACSCanto II 4-2-2 Configuration Intended Use The BD FACSLyric™ flow cytometer is intended for use as an in vitro diagnostic device for immunophenotyping using up to six fluorescence detection channels and two light scatter channels using a blue (488-
nm) and a red (640-nm) laser. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument. The BD FACSCanto™ II flow cytometers (4-2-2 and 5-3 configurations) function as part of a system with dedicated clinical software intended for use with cleared or approved in vitro diagnostic (IVD) assays that are indicated for use with the instrument for the identification and enumeration of human cell subsets. Only six detection channels using a blue (488 nm) and a red (633 nm) laser have been cleared for in vitro diagnostic use. For use with or without the BD FACS Sample Prep Assistant III. Forward Scatter Detection Photodiode with built-in 488/10 bandpass filter Same IVD Lasers/Excitation Blue Laser: Blue/488 nm, 20mW Same Fluorescence and Side Scatter Detection Side scatter and fluorescence · Reflective optics with single transmission bandpass filter in front of each PMT · High
Regulation section: |
idK170974_s8000_e10000 | K170974.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. | 44 0.93 0.0 0.22 0.47 1.06 Normal Average CD3+ % 76.74 0.68 0.07 0.34 0.10 0.77 CD3+% Tube A 76.64 0.85 0.12 0.31 0.0 0.91 CD3+% Tube B 76.84 1.00 0.0 0.23 0.22 1.05 CD4+ % 51.67 1.39 0.0 0.74 0.0 1.58 CD8+ % 23.23 0.83 0.0 0.0 0.19 0.85 CD19+% 12.02 0.64 0.07 0.0 0.11 0.66 CD16+CD56+% 10.30 0.57 0.03 0.16 0.15 0.62 17
c. Linearity/assay reportable range: The linearity study was performed based on recommendations in the CLSI document CLSI EP6-A6, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline. Linearity was evaluated using triplicate measurements of 11 concentrations of lymphocyte subsets across a range approximately 20 to 30% wider than the anticipated linear range. In addition, seven supplemental concentration levels for CD4 were used to evaluate linearity near the medical decision point at 50 cells/μL and 200 cells/μL for CD4 absolute counts. Linearity studies were performed on each configuration to verify that the relationship between the observed values and the true concentrations of the analyte was linear for each configuration. The objective of each linearity study was to estimate the linearity of the BD FACSLyric with BD FACSuite™ clinical software using the BD Multitest IMK Kit (4-color) and the BD Multitest 6-color TBNK reagent for the lyse/no-wash method of sample preparation. Whole blood samples collected in EDTA tubes were fractionated by centrifugation to isolate PBMCs, plasma, and RBCs. A low concentration pool was created using autologous plasma reconstituted with RBCs; a high concentration pool was created using concentrated PBMCs in autologous plasma and RBCs. Intermediate concentration levels were created by proportionally mixing high and low pools. Replicates of each dilution were stained with the BD Multitest IMK Kit (4-color) and BD Multitest 6-color TBNK Reagent in Trucount tubes. Regression statistics were provided for all each cellular subset. The instrument system using the FACSuiteClinical software for the IMK and TBNK assay was found to be linear for each parameter (absolute counts) for each configuration. d. Carryover: The carryover studies were performed based on CLSI H26-A2 Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Approved Standard- Second Edition. Sample Carryover: Specimen carry over studies were performed on the BD FACSLyric™ to determine whether results were affected by contamination from neighboring samples. System carryover was evaluated by estimating the percent carryover of abnormally high leucocyte count samples to abnormally low leucocyte count samples. Three high leucocyte concentration samples were acquired sequentially, immediately followed by the sequential acquisition of three low leucocyte concentration samples. Carryover of both BD FACS Universal Loader (UL) and manual acquisition was evaluated on three FACSLyric instruments (one 3-1 and two 4-3-3) using two different sample volumes, 500 uL and 1500 uL and calculating the percent difference according to the formula % Carryover = [(L1-L3)/H3-L3)]*100. Carryover from one specimen to another was demonstrated to be leucocyte carryover less than or equal to 0.1% for low carryover and less than or equal to 0.5% for 18
standard carryover on all three FACSLyric instruments. Reagent Carryover: Percent volume carryover was measured by enumeration of Trucount Control beads in known concentrations and sample volumes. Percent reagent carryover was then calculated using the volume carryover because the amount of reagent is consistent throughout the sample. Three replicates of Trucount tubes with Trucount High Control beads were run first, followed by three replicates of Trucount tubes without Trucount Control beads. The volume carryover was quantified by the number of Trucount High Control beads present in the first tube without Trucount Control beads (L1) after subtracting the number of events present in the third tube without Trucount Control beads (L3), this tube is considered background. This procedure was repeated three times on each instrument and each run was evaluated individually. The volume carryover experiment was carried out on three FACSLyric instruments using UL acquisition on two instruments and manual acquisition on one instrument. The amount of reagent being carried over is found to be well below the amount of reagent required for effective staining of the sample. e.
Interfering Substances: Not applicable 2. Other Supportive Instrument Performance Data Not Covered Above: Limit of Blank (LoB); Limit of Detection (LoD); Limit of Quantitation (LoQ): The study was performed in accordance with CLSI EP17-A2, Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline-
Second Edition. Twenty four samples with sixty total replicates were evaluated for each blank for LoB and low concentration sample for LoD per reagent lot, across four test days for each instrument configuration. Three lots of the reagent were collected for a total of 180 data points per assay and configuration combination. LoB and LoD for all reagents tested was less than 15 cells/μL. For CD4 Lymphocyte subset absolute counts of each of the reagents, the established LoB and LoD were less than 50 cells/μL. For LoQ determination, four low concentration pools were created by diluting normal whole blood with cell free plasma to achieve CD4 absolute counts of 10, 20, 30 and 50 cells/μL. Forty replicates were prepared from each of the concentration pools and were stained with two different lots of each reagent. Ten replicates from each concentration pool were run on each FACSLyric instrument configuration. The remaining ten replicates were run on the predicate device, FACSCanto II. The LoQ of the FACSLyric system with Multitest reagents was established for the CD3+, CD3+CD4+, CD3+CD8+, CD19+, CD16+CD56+ and CD45+ lymphocyte subsets. The LoQ is less than 50 cells/μL for CD4 absolute count. 19
Expected values/Reference range: The reference interval study was performed based on recommendations in the CLSI document CLSI EP28-A3c, How to Define and Determine Reference Intervals in the Clinical Laboratory, Approved Guideline-Second Edition. A total of 134 samples for Multitest 6-Color TBNK and 130 samples for Multitest IMK kit from one clinical site were evaluated. Reference Intervals for all lymphocyte subsets in the Multitest 6-Color TBNK and Multitest IMK kit were established for the FACSLyric system. Testing was performed using prospectively procured EDTA venous blood specimens from apparently healthy adult male and female subjects free of hematological abnormalities to satisfy age. Reference Intervals Analysis Results for Multitest 6-Color TBNK Parameters Reference Range AbsCD3+
856–2669 AbsCD4+
491–1734 AbsCD8+
162–1074 AbsCD19+
73–562 AbsCD16+CD56+
108–680 %CD3+
57.5–83.1 %CD4+
31.5–62.4 %CD8+
9.6–38.3 %CD19+
5.9–24.2 %CD16+CD56+
5.2–30.4 Reference Intervals Analysis Results for Multitest IMK kit Parameters Reference Range Average AbsCD3+
827–2547 AbsCD3+ Tube A 840−2641 AbsCD3+ Tube B 812−2655 AbsCD4+
488–1711 AbsCD8+
154–1097 AbsCD19+
60–551 AbsCD16+CD56+
102–617 Average %CD3+
56.9–82.5 %CD3+ Tube A 56.7−83.4 %CD3+ Tube B 56.7−82.5 %CD4+
32.4–63.2 %CD8+
9.0–39.0 %CD19+
5.1–23.0 %CD16+CD56+
5.4–30.0 K. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. 20
L. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
Proposed labeling: |
idK170974_s8000_e10000 | K170974.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | 19.44 0.93 0.0 0.22 0.47 1.06 Normal Average CD3+ % 76.74 0.68 0.07 0.34 0.10 0.77 CD3+% Tube A 76.64 0.85 0.12 0.31 0.0 0.91 CD3+% Tube B 76.84 1.00 0.0 0.23 0.22 1.05 CD4+ % 51.67 1.39 0.0 0.74 0.0 1.58 CD8+ % 23.23 0.83 0.0 0.0 0.19 0.85 CD19+% 12.02 0.64 0.07 0.0 0.11 0.66 CD16+CD56+% 10.30 0.57 0.03 0.16 0.15 0.62 17
c. Linearity/assay reportable range: The linearity study was performed based on recommendations in the CLSI document CLSI EP6-A6, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline. Linearity was evaluated using triplicate measurements of 11 concentrations of lymphocyte subsets across a range approximately 20 to 30% wider than the anticipated linear range. In addition, seven supplemental concentration levels for CD4 were used to evaluate linearity near the medical decision point at 50 cells/μL and 200 cells/μL for CD4 absolute counts. Linearity studies were performed on each configuration to verify that the relationship between the observed values and the true concentrations of the analyte was linear for each configuration. The objective of each linearity study was to estimate the linearity of the BD FACSLyric with BD FACSuite™ clinical software using the BD Multitest IMK Kit (4-color) and the BD Multitest 6-color TBNK reagent for the lyse/no-wash method of sample preparation. Whole blood samples collected in EDTA tubes were fractionated by centrifugation to isolate PBMCs, plasma, and RBCs. A low concentration pool was created using autologous plasma reconstituted with RBCs; a high concentration pool was created using concentrated PBMCs in autologous plasma and RBCs. Intermediate concentration levels were created by proportionally mixing high and low pools. Replicates of each dilution were stained with the BD Multitest IMK Kit (4-color) and BD Multitest 6-color TBNK Reagent in Trucount tubes. Regression statistics were provided for all each cellular subset. The instrument system using the FACSuiteClinical software for the IMK and TBNK assay was found to be linear for each parameter (absolute counts) for each configuration. d. Carryover: The carryover studies were performed based on CLSI H26-A2 Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Approved Standard- Second Edition. Sample Carryover: Specimen carry over studies were performed on the BD FACSLyric™ to determine whether results were affected by contamination from neighboring samples. System carryover was evaluated by estimating the percent carryover of abnormally high leucocyte count samples to abnormally low leucocyte count samples. Three high leucocyte concentration samples were acquired sequentially, immediately followed by the sequential acquisition of three low leucocyte concentration samples. Carryover of both BD FACS Universal Loader (UL) and manual acquisition was evaluated on three FACSLyric instruments (one 3-1 and two 4-3-3) using two different sample volumes, 500 uL and 1500 uL and calculating the percent difference according to the formula % Carryover = [(L1-L3)/H3-L3)]*100. Carryover from one specimen to another was demonstrated to be leucocyte carryover less than or equal to 0.1% for low carryover and less than or equal to 0.5% for 18
standard carryover on all three FACSLyric instruments. Reagent Carryover: Percent volume carryover was measured by enumeration of Trucount Control beads in known concentrations and sample volumes. Percent reagent carryover was then calculated using the volume carryover because the amount of reagent is consistent throughout the sample. Three replicates of Trucount tubes with Trucount High Control beads were run first, followed by three replicates of Trucount tubes without Trucount Control beads. The volume carryover was quantified by the number of Trucount High Control beads present in the first tube without Trucount Control beads (L1) after subtracting the number of events present in the third tube without Trucount Control beads (L3), this tube is considered background. This procedure was repeated three times on each instrument and each run was evaluated individually. The volume carryover experiment was carried out on three FACSLyric instruments using UL acquisition on two instruments and manual acquisition on one instrument. The amount of reagent being carried over is found to be well below the amount of reagent required for effective staining of the sample. e.
Interfering Substances: Not applicable 2. Other Supportive Instrument Performance Data Not Covered Above: Limit of Blank (LoB); Limit of Detection (LoD); Limit of Quantitation (LoQ): The study was performed in accordance with CLSI EP17-A2, Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline-
Second Edition. Twenty four samples with sixty total replicates were evaluated for each blank for LoB and low concentration sample for LoD per reagent lot, across four test days for each instrument configuration. Three lots of the reagent were collected for a total of 180 data points per assay and configuration combination. LoB and LoD for all reagents tested was less than 15 cells/μL. For CD4 Lymphocyte subset absolute counts of each of the reagents, the established LoB and LoD were less than 50 cells/μL. For LoQ determination, four low concentration pools were created by diluting normal whole blood with cell free plasma to achieve CD4 absolute counts of 10, 20, 30 and 50 cells/μL. Forty replicates were prepared from each of the concentration pools and were stained with two different lots of each reagent. Ten replicates from each concentration pool were run on each FACSLyric instrument configuration. The remaining ten replicates were run on the predicate device, FACSCanto II. The LoQ of the FACSLyric system with Multitest reagents was established for the CD3+, CD3+CD4+, CD3+CD8+, CD19+, CD16+CD56+ and CD45+ lymphocyte subsets. The LoQ is less than 50 cells/μL for CD4 absolute count. 19
Expected values/Reference range: The reference interval study was performed based on recommendations in the CLSI document CLSI EP28-A3c, How to Define and Determine Reference Intervals in the Clinical Laboratory, Approved Guideline-Second Edition. A total of 134 samples for Multitest 6-Color TBNK and 130 samples for Multitest IMK kit from one clinical site were evaluated. Reference Intervals for all lymphocyte subsets in the Multitest 6-Color TBNK and Multitest IMK kit were established for the FACSLyric system. Testing was performed using prospectively procured EDTA venous blood specimens from apparently healthy adult male and female subjects free of hematological abnormalities to satisfy age. Reference Intervals Analysis Results for Multitest 6-Color TBNK Parameters Reference Range AbsCD3+
856–2669 AbsCD4+
491–1734 AbsCD8+
162–1074 AbsCD19+
73–562 AbsCD16+CD56+
108–680 %CD3+
57.5–83.1 %CD4+
31.5–62.4 %CD8+
9.6–38.3 %CD19+
5.9–24.2 %CD16+CD56+
5.2–30.4 Reference Intervals Analysis Results for Multitest IMK kit Parameters Reference Range Average AbsCD3+
827–2547 AbsCD3+ Tube A 840−2641 AbsCD3+ Tube B 812−2655 AbsCD4+
488–1711 AbsCD8+
154–1097 AbsCD19+
60–551 AbsCD16+CD56+
102–617 Average %CD3+
56.9–82.5 %CD3+ Tube A 56.7−83.4 %CD3+ Tube B 56.7−82.5 %CD4+
32.4–63.2 %CD8+
9.0–39.0 %CD19+
5.1–23.0 %CD16+CD56+
5.4–30.0 K. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. 20
L. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
Conclusion: |
idK160585_s0_e2000 | K160585.txt | measurand | WBC (103/μL), RBC (106/μL), HGB (g/dL), HCT (%), PLT (103/μL), and RET (%) | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K160585 B. Purpose for Submission: To expand the intended use of an existing cleared calibrator (XN CAL; K141962) for use on an additional analyzer, the Sysmex XN-L Analyzer. The XN CAL has previously been cleared for use on other Sysmex XN Series analyzers – the XN-10, XN-11, XN-20, and XN-
21 analyzers. C. Measurand: Assayed hematology parameters: WBC (103/μL), RBC (106/μL), HGB (g/dL), HCT (%), PLT (103/μL), and RET (%) D. Type of Test: Quantitative E. Applicant: Streck, Inc. F. Proprietary and Established Names: XN CAL G. Regulatory Information: 1. Regulation section: 21 CFR § 864.8150, Calibrator for cell indices 2. Classification: Class II 3. Product code: KRX, Calibrator for cell indices 2 4. Panel: Hematology (81) H. Intended Use: 1. Intended use(s): XN CAL is used for the calibration and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. Assayed parameters include: WBC (103/μL), RBC (106/μL), HGB (g/dL), HCT (%), PLT (103/μL), and RET (%). 2. Indication(s) for use: Same as intended use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers I. Device Description: XN CAL is an in-vitro diagnostic product that contains the following: stabilized red blood cell component(s), stabilized white blood cell component(s), stabilized platelet component(s), and stabilized nucleated red blood cell component(s) in a preservative medium. The product is packaged in polypropylene plastic vials with screw caps. The vials will be packaged in five-welled or one-welled vacuum formed clamshell container with the Instructions for Use (IFU) assay sheet. The product must be stored at 2 – 8°C. J. Substantial Equivalence Information: 1. Predicate device name(s): XN CAL 2. Predicate 510(k) number(s): K141962 3. Comparison with predicate: 3 Similarities Item Device Predicate Intended Use XN CAL is used for the calibration and calibration verification of Sysmex XN series hematology analyzers. Assayed parameters include: WBC (103/μL), RBC (106/μL), HGB (g/dL), HCT (%), PLT (103/μL), and RET (%). Same Reagents XN CAL contains the following: stabilized red blood cell component(s), stabilized white blood cell component(s), stabilized platelet component(s), and stabilized nucleated red blood cell component(s) in a preservative medium. Same Storage Conditions 2–8°C Same Open Vial Stability 4 hours Same Differences Item Device Predicate Intended Use XN CAL is used for the calibration and calibration verification of the following Sysmex XN series hematology analyzers: XN-
10, XN-11, XN-20, XN-21, and XN-L. XN CAL predicate is NOT cleared for calibration and calibration verification of XN-L analyzers. Closed Vial Stability 35 days 49 days K. Standard/Guidance Document Referenced (if applicable): CLSI H7-A3: Procedure of Determining Packed Cell Volume by the Microhematocrit Method; Approved Standard – Third Edition. CLSI H15-A3: Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard – Third Edition. CLSI H26-A2: Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Approved Standard – Second Edition 4 CLSI EP05-A3: Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline – Third Edition. L. Test Principle: XN CAL was designed to function as a substitute for fresh whole blood to calibrate the Sysmex XN10/20, XN 11/21, and XN-L series hematology analyzers. This product is for in-
vitro diagnostic use to calibrate the following parameters: RBC (106/μL), HGB (g/dL), HCT (%), PLT (103/μL), WBC (103/μL), and RET (%). M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: i. Multi-site reproducibility study: Data was collected from Sysmex XN-L model analyzers at three sites – Streck, Sysmex-Buffalo Grove, and Sysmex-Mundelein with three different operators. Three separately manufactured lots of XN CAL were tested on each analyzer. The study was conducted over the course of 5 days, with three runs per day, and two replicates per run (5 days x 3 runs x 2 replicates x 3 lots x 3 sites). The means for each of the assayed parameters for each lot are indicated in Table 1, below. The total reproducibility estimates (Table 2, below) for each parameter for each lot include the repeatability (within-run), between-
run, between-day, and between-site precision estimates. Results across the three separately manufactured lots of XN CAL demonstrated consistent recovery across multiple instruments, at multiple sites. Table 1: Performance of XN CAL On Three XN-L Analyzers (3 sites) – Mean Values Parameter Mean Lot N WBC RBC HGB HCT PLT RET Lot 6144* 90 7.26 4.36 12.9 36.7 243 2.23 Lot 6172* 90 7.23 4.36 12.3 34.9 246 2.26 Lot 6200* 90 7.32 4.40 12.5 35.4 245 2.20 * = Within lot Table 2: Performance of XN CAL On Three XN-L Analyzers (3 sites) – Variability Estimates Reproducibility Estimates for Each Parameter Lot WBC RBC HGB HCT PLT RET SD %CV SD %CV SD %CV SD %CV SD %CV SD %CV Lot 6144* 0.16 2.2 0.06 1.3 0.1 1.1 0.9 2.3 8 3.1 0.13 5.9 Lot 6172* 0.21 2.9 0.05 1.2 0.1 1.2 0.7 2.1 10 4.1 0.17 7.4 Lot 6200* 0.18 2.4 0.05 1.2 0.1 1.1 0.8 2.3 12 4.7 0.15 7.0 * = Within lot 5 ii. Internal precision study: Performance data provided by the closed-vial stability study was used to support the internal precision study. In this study, performance of three (3) lots of XN CAL was evaluated at one site, on one instrument, for 21 non-consecutive days, two vials per day, and two replicates per vial. The internal precision for each lot of XN CAL was consistent across lots for each assayed parameter (see Tables 3 and 4, below). Total variability estimates (within-lab precision) included repeatability (within-run), between-vial, and between-day (Table 4, below). Table 3: XN CAL Internal Precision Study – Mean Values Parameter Mean Lot N WBC RBC HGB HCT PLT RET Lot 5201* 80 7.28 4.40 11.7 34.5 237 2.48 Lot 5229* 80 7.18 4.44 12.0 35.4 236 2.31 Lot 5257* 80 7.33 4.38 12.1 35.4 232 2.27 * = Within lot Table 4: Within Lab Precision for XN CAL Total variability (within-lab precision) for Each Parameter Lot WBC RBC HGB HCT PLT RET SD %CV SD %CV SD %CV SD %CV SD %CV SD %CV Lot 5201* 0.12 1.7 0.03 0.6 0.1 0.6 0.3 0.8 4 1.9 0.08 3.3 Lot 5229* 0.11 1.6 0.03 0.8 0.1 0.6 0.4 1.0 5 2.3 0.07 3.2 Lot 5257* 0.12 1.6 0.03 0.8 0.1 0.6 0.3 0.7 5 2.0 0.07 3.3 Between Lots 0.08 1.
Measurand: |
idK160585_s0_e2000 | K160585.txt | type of test | Quantitative | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K160585 B. Purpose for Submission: To expand the intended use of an existing cleared calibrator (XN CAL; K141962) for use on an additional analyzer, the Sysmex XN-L Analyzer. The XN CAL has previously been cleared for use on other Sysmex XN Series analyzers – the XN-10, XN-11, XN-20, and XN-
21 analyzers. C. Measurand: Assayed hematology parameters: WBC (103/μL), RBC (106/μL), HGB (g/dL), HCT (%), PLT (103/μL), and RET (%) D. Type of Test: Quantitative E. Applicant: Streck, Inc. F. Proprietary and Established Names: XN CAL G. Regulatory Information: 1. Regulation section: 21 CFR § 864.8150, Calibrator for cell indices 2. Classification: Class II 3. Product code: KRX, Calibrator for cell indices 2 4. Panel: Hematology (81) H. Intended Use: 1. Intended use(s): XN CAL is used for the calibration and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. Assayed parameters include: WBC (103/μL), RBC (106/μL), HGB (g/dL), HCT (%), PLT (103/μL), and RET (%). 2. Indication(s) for use: Same as intended use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers I. Device Description: XN CAL is an in-vitro diagnostic product that contains the following: stabilized red blood cell component(s), stabilized white blood cell component(s), stabilized platelet component(s), and stabilized nucleated red blood cell component(s) in a preservative medium. The product is packaged in polypropylene plastic vials with screw caps. The vials will be packaged in five-welled or one-welled vacuum formed clamshell container with the Instructions for Use (IFU) assay sheet. The product must be stored at 2 – 8°C. J. Substantial Equivalence Information: 1. Predicate device name(s): XN CAL 2. Predicate 510(k) number(s): K141962 3. Comparison with predicate: 3 Similarities Item Device Predicate Intended Use XN CAL is used for the calibration and calibration verification of Sysmex XN series hematology analyzers. Assayed parameters include: WBC (103/μL), RBC (106/μL), HGB (g/dL), HCT (%), PLT (103/μL), and RET (%). Same Reagents XN CAL contains the following: stabilized red blood cell component(s), stabilized white blood cell component(s), stabilized platelet component(s), and stabilized nucleated red blood cell component(s) in a preservative medium. Same Storage Conditions 2–8°C Same Open Vial Stability 4 hours Same Differences Item Device Predicate Intended Use XN CAL is used for the calibration and calibration verification of the following Sysmex XN series hematology analyzers: XN-
10, XN-11, XN-20, XN-21, and XN-L. XN CAL predicate is NOT cleared for calibration and calibration verification of XN-L analyzers. Closed Vial Stability 35 days 49 days K. Standard/Guidance Document Referenced (if applicable): CLSI H7-A3: Procedure of Determining Packed Cell Volume by the Microhematocrit Method; Approved Standard – Third Edition. CLSI H15-A3: Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard – Third Edition. CLSI H26-A2: Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Approved Standard – Second Edition 4 CLSI EP05-A3: Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline – Third Edition. L. Test Principle: XN CAL was designed to function as a substitute for fresh whole blood to calibrate the Sysmex XN10/20, XN 11/21, and XN-L series hematology analyzers. This product is for in-
vitro diagnostic use to calibrate the following parameters: RBC (106/μL), HGB (g/dL), HCT (%), PLT (103/μL), WBC (103/μL), and RET (%). M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: i. Multi-site reproducibility study: Data was collected from Sysmex XN-L model analyzers at three sites – Streck, Sysmex-Buffalo Grove, and Sysmex-Mundelein with three different operators. Three separately manufactured lots of XN CAL were tested on each analyzer. The study was conducted over the course of 5 days, with three runs per day, and two replicates per run (5 days x 3 runs x 2 replicates x 3 lots x 3 sites). The means for each of the assayed parameters for each lot are indicated in Table 1, below. The total reproducibility estimates (Table 2, below) for each parameter for each lot include the repeatability (within-run), between-
run, between-day, and between-site precision estimates. Results across the three separately manufactured lots of XN CAL demonstrated consistent recovery across multiple instruments, at multiple sites. Table 1: Performance of XN CAL On Three XN-L Analyzers (3 sites) – Mean Values Parameter Mean Lot N WBC RBC HGB HCT PLT RET Lot 6144* 90 7.26 4.36 12.9 36.7 243 2.23 Lot 6172* 90 7.23 4.36 12.3 34.9 246 2.26 Lot 6200* 90 7.32 4.40 12.5 35.4 245 2.20 * = Within lot Table 2: Performance of XN CAL On Three XN-L Analyzers (3 sites) – Variability Estimates Reproducibility Estimates for Each Parameter Lot WBC RBC HGB HCT PLT RET SD %CV SD %CV SD %CV SD %CV SD %CV SD %CV Lot 6144* 0.16 2.2 0.06 1.3 0.1 1.1 0.9 2.3 8 3.1 0.13 5.9 Lot 6172* 0.21 2.9 0.05 1.2 0.1 1.2 0.7 2.1 10 4.1 0.17 7.4 Lot 6200* 0.18 2.4 0.05 1.2 0.1 1.1 0.8 2.3 12 4.7 0.15 7.0 * = Within lot 5 ii. Internal precision study: Performance data provided by the closed-vial stability study was used to support the internal precision study. In this study, performance of three (3) lots of XN CAL was evaluated at one site, on one instrument, for 21 non-consecutive days, two vials per day, and two replicates per vial. The internal precision for each lot of XN CAL was consistent across lots for each assayed parameter (see Tables 3 and 4, below). Total variability estimates (within-lab precision) included repeatability (within-run), between-vial, and between-day (Table 4, below). Table 3: XN CAL Internal Precision Study – Mean Values Parameter Mean Lot N WBC RBC HGB HCT PLT RET Lot 5201* 80 7.28 4.40 11.7 34.5 237 2.48 Lot 5229* 80 7.18 4.44 12.0 35.4 236 2.31 Lot 5257* 80 7.33 4.38 12.1 35.4 232 2.27 * = Within lot Table 4: Within Lab Precision for XN CAL Total variability (within-lab precision) for Each Parameter Lot WBC RBC HGB HCT PLT RET SD %CV SD %CV SD %CV SD %CV SD %CV SD %CV Lot 5201* 0.12 1.7 0.03 0.6 0.1 0.6 0.3 0.8 4 1.9 0.08 3.3 Lot 5229* 0.11 1.6 0.03 0.8 0.1 0.6 0.4 1.0 5 2.3 0.07 3.2 Lot 5257* 0.12 1.6 0.03 0.8 0.1 0.6 0.3 0.7 5 2.0 0.07 3.3 Between Lots 0.08 1.
Type of test: |
idK160585_s0_e2000 | K160585.txt | classification | Class II | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K160585 B. Purpose for Submission: To expand the intended use of an existing cleared calibrator (XN CAL; K141962) for use on an additional analyzer, the Sysmex XN-L Analyzer. The XN CAL has previously been cleared for use on other Sysmex XN Series analyzers – the XN-10, XN-11, XN-20, and XN-
21 analyzers. C. Measurand: Assayed hematology parameters: WBC (103/μL), RBC (106/μL), HGB (g/dL), HCT (%), PLT (103/μL), and RET (%) D. Type of Test: Quantitative E. Applicant: Streck, Inc. F. Proprietary and Established Names: XN CAL G. Regulatory Information: 1. Regulation section: 21 CFR § 864.8150, Calibrator for cell indices 2. Classification: Class II 3. Product code: KRX, Calibrator for cell indices 2 4. Panel: Hematology (81) H. Intended Use: 1. Intended use(s): XN CAL is used for the calibration and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. Assayed parameters include: WBC (103/μL), RBC (106/μL), HGB (g/dL), HCT (%), PLT (103/μL), and RET (%). 2. Indication(s) for use: Same as intended use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers I. Device Description: XN CAL is an in-vitro diagnostic product that contains the following: stabilized red blood cell component(s), stabilized white blood cell component(s), stabilized platelet component(s), and stabilized nucleated red blood cell component(s) in a preservative medium. The product is packaged in polypropylene plastic vials with screw caps. The vials will be packaged in five-welled or one-welled vacuum formed clamshell container with the Instructions for Use (IFU) assay sheet. The product must be stored at 2 – 8°C. J. Substantial Equivalence Information: 1. Predicate device name(s): XN CAL 2. Predicate 510(k) number(s): K141962 3. Comparison with predicate: 3 Similarities Item Device Predicate Intended Use XN CAL is used for the calibration and calibration verification of Sysmex XN series hematology analyzers. Assayed parameters include: WBC (103/μL), RBC (106/μL), HGB (g/dL), HCT (%), PLT (103/μL), and RET (%). Same Reagents XN CAL contains the following: stabilized red blood cell component(s), stabilized white blood cell component(s), stabilized platelet component(s), and stabilized nucleated red blood cell component(s) in a preservative medium. Same Storage Conditions 2–8°C Same Open Vial Stability 4 hours Same Differences Item Device Predicate Intended Use XN CAL is used for the calibration and calibration verification of the following Sysmex XN series hematology analyzers: XN-
10, XN-11, XN-20, XN-21, and XN-L. XN CAL predicate is NOT cleared for calibration and calibration verification of XN-L analyzers. Closed Vial Stability 35 days 49 days K. Standard/Guidance Document Referenced (if applicable): CLSI H7-A3: Procedure of Determining Packed Cell Volume by the Microhematocrit Method; Approved Standard – Third Edition. CLSI H15-A3: Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard – Third Edition. CLSI H26-A2: Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Approved Standard – Second Edition 4 CLSI EP05-A3: Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline – Third Edition. L. Test Principle: XN CAL was designed to function as a substitute for fresh whole blood to calibrate the Sysmex XN10/20, XN 11/21, and XN-L series hematology analyzers. This product is for in-
vitro diagnostic use to calibrate the following parameters: RBC (106/μL), HGB (g/dL), HCT (%), PLT (103/μL), WBC (103/μL), and RET (%). M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: i. Multi-site reproducibility study: Data was collected from Sysmex XN-L model analyzers at three sites – Streck, Sysmex-Buffalo Grove, and Sysmex-Mundelein with three different operators. Three separately manufactured lots of XN CAL were tested on each analyzer. The study was conducted over the course of 5 days, with three runs per day, and two replicates per run (5 days x 3 runs x 2 replicates x 3 lots x 3 sites). The means for each of the assayed parameters for each lot are indicated in Table 1, below. The total reproducibility estimates (Table 2, below) for each parameter for each lot include the repeatability (within-run), between-
run, between-day, and between-site precision estimates. Results across the three separately manufactured lots of XN CAL demonstrated consistent recovery across multiple instruments, at multiple sites. Table 1: Performance of XN CAL On Three XN-L Analyzers (3 sites) – Mean Values Parameter Mean Lot N WBC RBC HGB HCT PLT RET Lot 6144* 90 7.26 4.36 12.9 36.7 243 2.23 Lot 6172* 90 7.23 4.36 12.3 34.9 246 2.26 Lot 6200* 90 7.32 4.40 12.5 35.4 245 2.20 * = Within lot Table 2: Performance of XN CAL On Three XN-L Analyzers (3 sites) – Variability Estimates Reproducibility Estimates for Each Parameter Lot WBC RBC HGB HCT PLT RET SD %CV SD %CV SD %CV SD %CV SD %CV SD %CV Lot 6144* 0.16 2.2 0.06 1.3 0.1 1.1 0.9 2.3 8 3.1 0.13 5.9 Lot 6172* 0.21 2.9 0.05 1.2 0.1 1.2 0.7 2.1 10 4.1 0.17 7.4 Lot 6200* 0.18 2.4 0.05 1.2 0.1 1.1 0.8 2.3 12 4.7 0.15 7.0 * = Within lot 5 ii. Internal precision study: Performance data provided by the closed-vial stability study was used to support the internal precision study. In this study, performance of three (3) lots of XN CAL was evaluated at one site, on one instrument, for 21 non-consecutive days, two vials per day, and two replicates per vial. The internal precision for each lot of XN CAL was consistent across lots for each assayed parameter (see Tables 3 and 4, below). Total variability estimates (within-lab precision) included repeatability (within-run), between-vial, and between-day (Table 4, below). Table 3: XN CAL Internal Precision Study – Mean Values Parameter Mean Lot N WBC RBC HGB HCT PLT RET Lot 5201* 80 7.28 4.40 11.7 34.5 237 2.48 Lot 5229* 80 7.18 4.44 12.0 35.4 236 2.31 Lot 5257* 80 7.33 4.38 12.1 35.4 232 2.27 * = Within lot Table 4: Within Lab Precision for XN CAL Total variability (within-lab precision) for Each Parameter Lot WBC RBC HGB HCT PLT RET SD %CV SD %CV SD %CV SD %CV SD %CV SD %CV Lot 5201* 0.12 1.7 0.03 0.6 0.1 0.6 0.3 0.8 4 1.9 0.08 3.3 Lot 5229* 0.11 1.6 0.03 0.8 0.1 0.6 0.4 1.0 5 2.3 0.07 3.2 Lot 5257* 0.12 1.6 0.03 0.8 0.1 0.6 0.3 0.7 5 2.0 0.07 3.3 Between Lots 0.08 1.
Classification: |
idK160585_s0_e2000 | K160585.txt | product code | KRX, Calibrator for cell indices | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K160585 B. Purpose for Submission: To expand the intended use of an existing cleared calibrator (XN CAL; K141962) for use on an additional analyzer, the Sysmex XN-L Analyzer. The XN CAL has previously been cleared for use on other Sysmex XN Series analyzers – the XN-10, XN-11, XN-20, and XN-
21 analyzers. C. Measurand: Assayed hematology parameters: WBC (103/μL), RBC (106/μL), HGB (g/dL), HCT (%), PLT (103/μL), and RET (%) D. Type of Test: Quantitative E. Applicant: Streck, Inc. F. Proprietary and Established Names: XN CAL G. Regulatory Information: 1. Regulation section: 21 CFR § 864.8150, Calibrator for cell indices 2. Classification: Class II 3. Product code: KRX, Calibrator for cell indices 2 4. Panel: Hematology (81) H. Intended Use: 1. Intended use(s): XN CAL is used for the calibration and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. Assayed parameters include: WBC (103/μL), RBC (106/μL), HGB (g/dL), HCT (%), PLT (103/μL), and RET (%). 2. Indication(s) for use: Same as intended use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers I. Device Description: XN CAL is an in-vitro diagnostic product that contains the following: stabilized red blood cell component(s), stabilized white blood cell component(s), stabilized platelet component(s), and stabilized nucleated red blood cell component(s) in a preservative medium. The product is packaged in polypropylene plastic vials with screw caps. The vials will be packaged in five-welled or one-welled vacuum formed clamshell container with the Instructions for Use (IFU) assay sheet. The product must be stored at 2 – 8°C. J. Substantial Equivalence Information: 1. Predicate device name(s): XN CAL 2. Predicate 510(k) number(s): K141962 3. Comparison with predicate: 3 Similarities Item Device Predicate Intended Use XN CAL is used for the calibration and calibration verification of Sysmex XN series hematology analyzers. Assayed parameters include: WBC (103/μL), RBC (106/μL), HGB (g/dL), HCT (%), PLT (103/μL), and RET (%). Same Reagents XN CAL contains the following: stabilized red blood cell component(s), stabilized white blood cell component(s), stabilized platelet component(s), and stabilized nucleated red blood cell component(s) in a preservative medium. Same Storage Conditions 2–8°C Same Open Vial Stability 4 hours Same Differences Item Device Predicate Intended Use XN CAL is used for the calibration and calibration verification of the following Sysmex XN series hematology analyzers: XN-
10, XN-11, XN-20, XN-21, and XN-L. XN CAL predicate is NOT cleared for calibration and calibration verification of XN-L analyzers. Closed Vial Stability 35 days 49 days K. Standard/Guidance Document Referenced (if applicable): CLSI H7-A3: Procedure of Determining Packed Cell Volume by the Microhematocrit Method; Approved Standard – Third Edition. CLSI H15-A3: Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard – Third Edition. CLSI H26-A2: Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Approved Standard – Second Edition 4 CLSI EP05-A3: Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline – Third Edition. L. Test Principle: XN CAL was designed to function as a substitute for fresh whole blood to calibrate the Sysmex XN10/20, XN 11/21, and XN-L series hematology analyzers. This product is for in-
vitro diagnostic use to calibrate the following parameters: RBC (106/μL), HGB (g/dL), HCT (%), PLT (103/μL), WBC (103/μL), and RET (%). M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: i. Multi-site reproducibility study: Data was collected from Sysmex XN-L model analyzers at three sites – Streck, Sysmex-Buffalo Grove, and Sysmex-Mundelein with three different operators. Three separately manufactured lots of XN CAL were tested on each analyzer. The study was conducted over the course of 5 days, with three runs per day, and two replicates per run (5 days x 3 runs x 2 replicates x 3 lots x 3 sites). The means for each of the assayed parameters for each lot are indicated in Table 1, below. The total reproducibility estimates (Table 2, below) for each parameter for each lot include the repeatability (within-run), between-
run, between-day, and between-site precision estimates. Results across the three separately manufactured lots of XN CAL demonstrated consistent recovery across multiple instruments, at multiple sites. Table 1: Performance of XN CAL On Three XN-L Analyzers (3 sites) – Mean Values Parameter Mean Lot N WBC RBC HGB HCT PLT RET Lot 6144* 90 7.26 4.36 12.9 36.7 243 2.23 Lot 6172* 90 7.23 4.36 12.3 34.9 246 2.26 Lot 6200* 90 7.32 4.40 12.5 35.4 245 2.20 * = Within lot Table 2: Performance of XN CAL On Three XN-L Analyzers (3 sites) – Variability Estimates Reproducibility Estimates for Each Parameter Lot WBC RBC HGB HCT PLT RET SD %CV SD %CV SD %CV SD %CV SD %CV SD %CV Lot 6144* 0.16 2.2 0.06 1.3 0.1 1.1 0.9 2.3 8 3.1 0.13 5.9 Lot 6172* 0.21 2.9 0.05 1.2 0.1 1.2 0.7 2.1 10 4.1 0.17 7.4 Lot 6200* 0.18 2.4 0.05 1.2 0.1 1.1 0.8 2.3 12 4.7 0.15 7.0 * = Within lot 5 ii. Internal precision study: Performance data provided by the closed-vial stability study was used to support the internal precision study. In this study, performance of three (3) lots of XN CAL was evaluated at one site, on one instrument, for 21 non-consecutive days, two vials per day, and two replicates per vial. The internal precision for each lot of XN CAL was consistent across lots for each assayed parameter (see Tables 3 and 4, below). Total variability estimates (within-lab precision) included repeatability (within-run), between-vial, and between-day (Table 4, below). Table 3: XN CAL Internal Precision Study – Mean Values Parameter Mean Lot N WBC RBC HGB HCT PLT RET Lot 5201* 80 7.28 4.40 11.7 34.5 237 2.48 Lot 5229* 80 7.18 4.44 12.0 35.4 236 2.31 Lot 5257* 80 7.33 4.38 12.1 35.4 232 2.27 * = Within lot Table 4: Within Lab Precision for XN CAL Total variability (within-lab precision) for Each Parameter Lot WBC RBC HGB HCT PLT RET SD %CV SD %CV SD %CV SD %CV SD %CV SD %CV Lot 5201* 0.12 1.7 0.03 0.6 0.1 0.6 0.3 0.8 4 1.9 0.08 3.3 Lot 5229* 0.11 1.6 0.03 0.8 0.1 0.6 0.4 1.0 5 2.3 0.07 3.2 Lot 5257* 0.12 1.6 0.03 0.8 0.1 0.6 0.3 0.7 5 2.0 0.07 3.3 Between Lots 0.08 1.
Product code: |
idK160585_s0_e2000 | K160585.txt | panel | Hematology (81) | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K160585 B. Purpose for Submission: To expand the intended use of an existing cleared calibrator (XN CAL; K141962) for use on an additional analyzer, the Sysmex XN-L Analyzer. The XN CAL has previously been cleared for use on other Sysmex XN Series analyzers – the XN-10, XN-11, XN-20, and XN-
21 analyzers. C. Measurand: Assayed hematology parameters: WBC (103/μL), RBC (106/μL), HGB (g/dL), HCT (%), PLT (103/μL), and RET (%) D. Type of Test: Quantitative E. Applicant: Streck, Inc. F. Proprietary and Established Names: XN CAL G. Regulatory Information: 1. Regulation section: 21 CFR § 864.8150, Calibrator for cell indices 2. Classification: Class II 3. Product code: KRX, Calibrator for cell indices 2 4. Panel: Hematology (81) H. Intended Use: 1. Intended use(s): XN CAL is used for the calibration and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. Assayed parameters include: WBC (103/μL), RBC (106/μL), HGB (g/dL), HCT (%), PLT (103/μL), and RET (%). 2. Indication(s) for use: Same as intended use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers I. Device Description: XN CAL is an in-vitro diagnostic product that contains the following: stabilized red blood cell component(s), stabilized white blood cell component(s), stabilized platelet component(s), and stabilized nucleated red blood cell component(s) in a preservative medium. The product is packaged in polypropylene plastic vials with screw caps. The vials will be packaged in five-welled or one-welled vacuum formed clamshell container with the Instructions for Use (IFU) assay sheet. The product must be stored at 2 – 8°C. J. Substantial Equivalence Information: 1. Predicate device name(s): XN CAL 2. Predicate 510(k) number(s): K141962 3. Comparison with predicate: 3 Similarities Item Device Predicate Intended Use XN CAL is used for the calibration and calibration verification of Sysmex XN series hematology analyzers. Assayed parameters include: WBC (103/μL), RBC (106/μL), HGB (g/dL), HCT (%), PLT (103/μL), and RET (%). Same Reagents XN CAL contains the following: stabilized red blood cell component(s), stabilized white blood cell component(s), stabilized platelet component(s), and stabilized nucleated red blood cell component(s) in a preservative medium. Same Storage Conditions 2–8°C Same Open Vial Stability 4 hours Same Differences Item Device Predicate Intended Use XN CAL is used for the calibration and calibration verification of the following Sysmex XN series hematology analyzers: XN-
10, XN-11, XN-20, XN-21, and XN-L. XN CAL predicate is NOT cleared for calibration and calibration verification of XN-L analyzers. Closed Vial Stability 35 days 49 days K. Standard/Guidance Document Referenced (if applicable): CLSI H7-A3: Procedure of Determining Packed Cell Volume by the Microhematocrit Method; Approved Standard – Third Edition. CLSI H15-A3: Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard – Third Edition. CLSI H26-A2: Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Approved Standard – Second Edition 4 CLSI EP05-A3: Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline – Third Edition. L. Test Principle: XN CAL was designed to function as a substitute for fresh whole blood to calibrate the Sysmex XN10/20, XN 11/21, and XN-L series hematology analyzers. This product is for in-
vitro diagnostic use to calibrate the following parameters: RBC (106/μL), HGB (g/dL), HCT (%), PLT (103/μL), WBC (103/μL), and RET (%). M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: i. Multi-site reproducibility study: Data was collected from Sysmex XN-L model analyzers at three sites – Streck, Sysmex-Buffalo Grove, and Sysmex-Mundelein with three different operators. Three separately manufactured lots of XN CAL were tested on each analyzer. The study was conducted over the course of 5 days, with three runs per day, and two replicates per run (5 days x 3 runs x 2 replicates x 3 lots x 3 sites). The means for each of the assayed parameters for each lot are indicated in Table 1, below. The total reproducibility estimates (Table 2, below) for each parameter for each lot include the repeatability (within-run), between-
run, between-day, and between-site precision estimates. Results across the three separately manufactured lots of XN CAL demonstrated consistent recovery across multiple instruments, at multiple sites. Table 1: Performance of XN CAL On Three XN-L Analyzers (3 sites) – Mean Values Parameter Mean Lot N WBC RBC HGB HCT PLT RET Lot 6144* 90 7.26 4.36 12.9 36.7 243 2.23 Lot 6172* 90 7.23 4.36 12.3 34.9 246 2.26 Lot 6200* 90 7.32 4.40 12.5 35.4 245 2.20 * = Within lot Table 2: Performance of XN CAL On Three XN-L Analyzers (3 sites) – Variability Estimates Reproducibility Estimates for Each Parameter Lot WBC RBC HGB HCT PLT RET SD %CV SD %CV SD %CV SD %CV SD %CV SD %CV Lot 6144* 0.16 2.2 0.06 1.3 0.1 1.1 0.9 2.3 8 3.1 0.13 5.9 Lot 6172* 0.21 2.9 0.05 1.2 0.1 1.2 0.7 2.1 10 4.1 0.17 7.4 Lot 6200* 0.18 2.4 0.05 1.2 0.1 1.1 0.8 2.3 12 4.7 0.15 7.0 * = Within lot 5 ii. Internal precision study: Performance data provided by the closed-vial stability study was used to support the internal precision study. In this study, performance of three (3) lots of XN CAL was evaluated at one site, on one instrument, for 21 non-consecutive days, two vials per day, and two replicates per vial. The internal precision for each lot of XN CAL was consistent across lots for each assayed parameter (see Tables 3 and 4, below). Total variability estimates (within-lab precision) included repeatability (within-run), between-vial, and between-day (Table 4, below). Table 3: XN CAL Internal Precision Study – Mean Values Parameter Mean Lot N WBC RBC HGB HCT PLT RET Lot 5201* 80 7.28 4.40 11.7 34.5 237 2.48 Lot 5229* 80 7.18 4.44 12.0 35.4 236 2.31 Lot 5257* 80 7.33 4.38 12.1 35.4 232 2.27 * = Within lot Table 4: Within Lab Precision for XN CAL Total variability (within-lab precision) for Each Parameter Lot WBC RBC HGB HCT PLT RET SD %CV SD %CV SD %CV SD %CV SD %CV SD %CV Lot 5201* 0.12 1.7 0.03 0.6 0.1 0.6 0.3 0.8 4 1.9 0.08 3.3 Lot 5229* 0.11 1.6 0.03 0.8 0.1 0.6 0.4 1.0 5 2.3 0.07 3.2 Lot 5257* 0.12 1.6 0.03 0.8 0.1 0.6 0.3 0.7 5 2.0 0.07 3.3 Between Lots 0.08 1.
Panel: |
idK160585_s0_e2000 | K160585.txt | predicate device name | XN CAL | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K160585 B. Purpose for Submission: To expand the intended use of an existing cleared calibrator (XN CAL; K141962) for use on an additional analyzer, the Sysmex XN-L Analyzer. The XN CAL has previously been cleared for use on other Sysmex XN Series analyzers – the XN-10, XN-11, XN-20, and XN-
21 analyzers. C. Measurand: Assayed hematology parameters: WBC (103/μL), RBC (106/μL), HGB (g/dL), HCT (%), PLT (103/μL), and RET (%) D. Type of Test: Quantitative E. Applicant: Streck, Inc. F. Proprietary and Established Names: XN CAL G. Regulatory Information: 1. Regulation section: 21 CFR § 864.8150, Calibrator for cell indices 2. Classification: Class II 3. Product code: KRX, Calibrator for cell indices 2 4. Panel: Hematology (81) H. Intended Use: 1. Intended use(s): XN CAL is used for the calibration and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. Assayed parameters include: WBC (103/μL), RBC (106/μL), HGB (g/dL), HCT (%), PLT (103/μL), and RET (%). 2. Indication(s) for use: Same as intended use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers I. Device Description: XN CAL is an in-vitro diagnostic product that contains the following: stabilized red blood cell component(s), stabilized white blood cell component(s), stabilized platelet component(s), and stabilized nucleated red blood cell component(s) in a preservative medium. The product is packaged in polypropylene plastic vials with screw caps. The vials will be packaged in five-welled or one-welled vacuum formed clamshell container with the Instructions for Use (IFU) assay sheet. The product must be stored at 2 – 8°C. J. Substantial Equivalence Information: 1. Predicate device name(s): XN CAL 2. Predicate 510(k) number(s): K141962 3. Comparison with predicate: 3 Similarities Item Device Predicate Intended Use XN CAL is used for the calibration and calibration verification of Sysmex XN series hematology analyzers. Assayed parameters include: WBC (103/μL), RBC (106/μL), HGB (g/dL), HCT (%), PLT (103/μL), and RET (%). Same Reagents XN CAL contains the following: stabilized red blood cell component(s), stabilized white blood cell component(s), stabilized platelet component(s), and stabilized nucleated red blood cell component(s) in a preservative medium. Same Storage Conditions 2–8°C Same Open Vial Stability 4 hours Same Differences Item Device Predicate Intended Use XN CAL is used for the calibration and calibration verification of the following Sysmex XN series hematology analyzers: XN-
10, XN-11, XN-20, XN-21, and XN-L. XN CAL predicate is NOT cleared for calibration and calibration verification of XN-L analyzers. Closed Vial Stability 35 days 49 days K. Standard/Guidance Document Referenced (if applicable): CLSI H7-A3: Procedure of Determining Packed Cell Volume by the Microhematocrit Method; Approved Standard – Third Edition. CLSI H15-A3: Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard – Third Edition. CLSI H26-A2: Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Approved Standard – Second Edition 4 CLSI EP05-A3: Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline – Third Edition. L. Test Principle: XN CAL was designed to function as a substitute for fresh whole blood to calibrate the Sysmex XN10/20, XN 11/21, and XN-L series hematology analyzers. This product is for in-
vitro diagnostic use to calibrate the following parameters: RBC (106/μL), HGB (g/dL), HCT (%), PLT (103/μL), WBC (103/μL), and RET (%). M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: i. Multi-site reproducibility study: Data was collected from Sysmex XN-L model analyzers at three sites – Streck, Sysmex-Buffalo Grove, and Sysmex-Mundelein with three different operators. Three separately manufactured lots of XN CAL were tested on each analyzer. The study was conducted over the course of 5 days, with three runs per day, and two replicates per run (5 days x 3 runs x 2 replicates x 3 lots x 3 sites). The means for each of the assayed parameters for each lot are indicated in Table 1, below. The total reproducibility estimates (Table 2, below) for each parameter for each lot include the repeatability (within-run), between-
run, between-day, and between-site precision estimates. Results across the three separately manufactured lots of XN CAL demonstrated consistent recovery across multiple instruments, at multiple sites. Table 1: Performance of XN CAL On Three XN-L Analyzers (3 sites) – Mean Values Parameter Mean Lot N WBC RBC HGB HCT PLT RET Lot 6144* 90 7.26 4.36 12.9 36.7 243 2.23 Lot 6172* 90 7.23 4.36 12.3 34.9 246 2.26 Lot 6200* 90 7.32 4.40 12.5 35.4 245 2.20 * = Within lot Table 2: Performance of XN CAL On Three XN-L Analyzers (3 sites) – Variability Estimates Reproducibility Estimates for Each Parameter Lot WBC RBC HGB HCT PLT RET SD %CV SD %CV SD %CV SD %CV SD %CV SD %CV Lot 6144* 0.16 2.2 0.06 1.3 0.1 1.1 0.9 2.3 8 3.1 0.13 5.9 Lot 6172* 0.21 2.9 0.05 1.2 0.1 1.2 0.7 2.1 10 4.1 0.17 7.4 Lot 6200* 0.18 2.4 0.05 1.2 0.1 1.1 0.8 2.3 12 4.7 0.15 7.0 * = Within lot 5 ii. Internal precision study: Performance data provided by the closed-vial stability study was used to support the internal precision study. In this study, performance of three (3) lots of XN CAL was evaluated at one site, on one instrument, for 21 non-consecutive days, two vials per day, and two replicates per vial. The internal precision for each lot of XN CAL was consistent across lots for each assayed parameter (see Tables 3 and 4, below). Total variability estimates (within-lab precision) included repeatability (within-run), between-vial, and between-day (Table 4, below). Table 3: XN CAL Internal Precision Study – Mean Values Parameter Mean Lot N WBC RBC HGB HCT PLT RET Lot 5201* 80 7.28 4.40 11.7 34.5 237 2.48 Lot 5229* 80 7.18 4.44 12.0 35.4 236 2.31 Lot 5257* 80 7.33 4.38 12.1 35.4 232 2.27 * = Within lot Table 4: Within Lab Precision for XN CAL Total variability (within-lab precision) for Each Parameter Lot WBC RBC HGB HCT PLT RET SD %CV SD %CV SD %CV SD %CV SD %CV SD %CV Lot 5201* 0.12 1.7 0.03 0.6 0.1 0.6 0.3 0.8 4 1.9 0.08 3.3 Lot 5229* 0.11 1.6 0.03 0.8 0.1 0.6 0.4 1.0 5 2.3 0.07 3.2 Lot 5257* 0.12 1.6 0.03 0.8 0.1 0.6 0.3 0.7 5 2.0 0.07 3.3 Between Lots 0.08 1.
Predicate device name: |
idK160585_s0_e2000 | K160585.txt | applicant | Streck, Inc. | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K160585 B. Purpose for Submission: To expand the intended use of an existing cleared calibrator (XN CAL; K141962) for use on an additional analyzer, the Sysmex XN-L Analyzer. The XN CAL has previously been cleared for use on other Sysmex XN Series analyzers – the XN-10, XN-11, XN-20, and XN-
21 analyzers. C. Measurand: Assayed hematology parameters: WBC (103/μL), RBC (106/μL), HGB (g/dL), HCT (%), PLT (103/μL), and RET (%) D. Type of Test: Quantitative E. Applicant: Streck, Inc. F. Proprietary and Established Names: XN CAL G. Regulatory Information: 1. Regulation section: 21 CFR § 864.8150, Calibrator for cell indices 2. Classification: Class II 3. Product code: KRX, Calibrator for cell indices 2 4. Panel: Hematology (81) H. Intended Use: 1. Intended use(s): XN CAL is used for the calibration and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. Assayed parameters include: WBC (103/μL), RBC (106/μL), HGB (g/dL), HCT (%), PLT (103/μL), and RET (%). 2. Indication(s) for use: Same as intended use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers I. Device Description: XN CAL is an in-vitro diagnostic product that contains the following: stabilized red blood cell component(s), stabilized white blood cell component(s), stabilized platelet component(s), and stabilized nucleated red blood cell component(s) in a preservative medium. The product is packaged in polypropylene plastic vials with screw caps. The vials will be packaged in five-welled or one-welled vacuum formed clamshell container with the Instructions for Use (IFU) assay sheet. The product must be stored at 2 – 8°C. J. Substantial Equivalence Information: 1. Predicate device name(s): XN CAL 2. Predicate 510(k) number(s): K141962 3. Comparison with predicate: 3 Similarities Item Device Predicate Intended Use XN CAL is used for the calibration and calibration verification of Sysmex XN series hematology analyzers. Assayed parameters include: WBC (103/μL), RBC (106/μL), HGB (g/dL), HCT (%), PLT (103/μL), and RET (%). Same Reagents XN CAL contains the following: stabilized red blood cell component(s), stabilized white blood cell component(s), stabilized platelet component(s), and stabilized nucleated red blood cell component(s) in a preservative medium. Same Storage Conditions 2–8°C Same Open Vial Stability 4 hours Same Differences Item Device Predicate Intended Use XN CAL is used for the calibration and calibration verification of the following Sysmex XN series hematology analyzers: XN-
10, XN-11, XN-20, XN-21, and XN-L. XN CAL predicate is NOT cleared for calibration and calibration verification of XN-L analyzers. Closed Vial Stability 35 days 49 days K. Standard/Guidance Document Referenced (if applicable): CLSI H7-A3: Procedure of Determining Packed Cell Volume by the Microhematocrit Method; Approved Standard – Third Edition. CLSI H15-A3: Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard – Third Edition. CLSI H26-A2: Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Approved Standard – Second Edition 4 CLSI EP05-A3: Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline – Third Edition. L. Test Principle: XN CAL was designed to function as a substitute for fresh whole blood to calibrate the Sysmex XN10/20, XN 11/21, and XN-L series hematology analyzers. This product is for in-
vitro diagnostic use to calibrate the following parameters: RBC (106/μL), HGB (g/dL), HCT (%), PLT (103/μL), WBC (103/μL), and RET (%). M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: i. Multi-site reproducibility study: Data was collected from Sysmex XN-L model analyzers at three sites – Streck, Sysmex-Buffalo Grove, and Sysmex-Mundelein with three different operators. Three separately manufactured lots of XN CAL were tested on each analyzer. The study was conducted over the course of 5 days, with three runs per day, and two replicates per run (5 days x 3 runs x 2 replicates x 3 lots x 3 sites). The means for each of the assayed parameters for each lot are indicated in Table 1, below. The total reproducibility estimates (Table 2, below) for each parameter for each lot include the repeatability (within-run), between-
run, between-day, and between-site precision estimates. Results across the three separately manufactured lots of XN CAL demonstrated consistent recovery across multiple instruments, at multiple sites. Table 1: Performance of XN CAL On Three XN-L Analyzers (3 sites) – Mean Values Parameter Mean Lot N WBC RBC HGB HCT PLT RET Lot 6144* 90 7.26 4.36 12.9 36.7 243 2.23 Lot 6172* 90 7.23 4.36 12.3 34.9 246 2.26 Lot 6200* 90 7.32 4.40 12.5 35.4 245 2.20 * = Within lot Table 2: Performance of XN CAL On Three XN-L Analyzers (3 sites) – Variability Estimates Reproducibility Estimates for Each Parameter Lot WBC RBC HGB HCT PLT RET SD %CV SD %CV SD %CV SD %CV SD %CV SD %CV Lot 6144* 0.16 2.2 0.06 1.3 0.1 1.1 0.9 2.3 8 3.1 0.13 5.9 Lot 6172* 0.21 2.9 0.05 1.2 0.1 1.2 0.7 2.1 10 4.1 0.17 7.4 Lot 6200* 0.18 2.4 0.05 1.2 0.1 1.1 0.8 2.3 12 4.7 0.15 7.0 * = Within lot 5 ii. Internal precision study: Performance data provided by the closed-vial stability study was used to support the internal precision study. In this study, performance of three (3) lots of XN CAL was evaluated at one site, on one instrument, for 21 non-consecutive days, two vials per day, and two replicates per vial. The internal precision for each lot of XN CAL was consistent across lots for each assayed parameter (see Tables 3 and 4, below). Total variability estimates (within-lab precision) included repeatability (within-run), between-vial, and between-day (Table 4, below). Table 3: XN CAL Internal Precision Study – Mean Values Parameter Mean Lot N WBC RBC HGB HCT PLT RET Lot 5201* 80 7.28 4.40 11.7 34.5 237 2.48 Lot 5229* 80 7.18 4.44 12.0 35.4 236 2.31 Lot 5257* 80 7.33 4.38 12.1 35.4 232 2.27 * = Within lot Table 4: Within Lab Precision for XN CAL Total variability (within-lab precision) for Each Parameter Lot WBC RBC HGB HCT PLT RET SD %CV SD %CV SD %CV SD %CV SD %CV SD %CV Lot 5201* 0.12 1.7 0.03 0.6 0.1 0.6 0.3 0.8 4 1.9 0.08 3.3 Lot 5229* 0.11 1.6 0.03 0.8 0.1 0.6 0.4 1.0 5 2.3 0.07 3.2 Lot 5257* 0.12 1.6 0.03 0.8 0.1 0.6 0.3 0.7 5 2.0 0.07 3.3 Between Lots 0.08 1.
Applicant: |
idK160585_s0_e2000 | K160585.txt | proprietary and established names | XN CAL | IAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K160585 B. Purpose for Submission: To expand the intended use of an existing cleared calibrator (XN CAL; K141962) for use on an additional analyzer, the Sysmex XN-L Analyzer. The XN CAL has previously been cleared for use on other Sysmex XN Series analyzers – the XN-10, XN-11, XN-20, and XN-
21 analyzers. C. Measurand: Assayed hematology parameters: WBC (103/μL), RBC (106/μL), HGB (g/dL), HCT (%), PLT (103/μL), and RET (%) D. Type of Test: Quantitative E. Applicant: Streck, Inc. F. Proprietary and Established Names: XN CAL G. Regulatory Information: 1. Regulation section: 21 CFR § 864.8150, Calibrator for cell indices 2. Classification: Class II 3. Product code: KRX, Calibrator for cell indices 2 4. Panel: Hematology (81) H. Intended Use: 1. Intended use(s): XN CAL is used for the calibration and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. Assayed parameters include: WBC (103/μL), RBC (106/μL), HGB (g/dL), HCT (%), PLT (103/μL), and RET (%). 2. Indication(s) for use: Same as intended use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers I. Device Description: XN CAL is an in-vitro diagnostic product that contains the following: stabilized red blood cell component(s), stabilized white blood cell component(s), stabilized platelet component(s), and stabilized nucleated red blood cell component(s) in a preservative medium. The product is packaged in polypropylene plastic vials with screw caps. The vials will be packaged in five-welled or one-welled vacuum formed clamshell container with the Instructions for Use (IFU) assay sheet. The product must be stored at 2 – 8°C. J. Substantial Equivalence Information: 1. Predicate device name(s): XN CAL 2. Predicate 510(k) number(s): K141962 3. Comparison with predicate: 3 Similarities Item Device Predicate Intended Use XN CAL is used for the calibration and calibration verification of Sysmex XN series hematology analyzers. Assayed parameters include: WBC (103/μL), RBC (106/μL), HGB (g/dL), HCT (%), PLT (103/μL), and RET (%). Same Reagents XN CAL contains the following: stabilized red blood cell component(s), stabilized white blood cell component(s), stabilized platelet component(s), and stabilized nucleated red blood cell component(s) in a preservative medium. Same Storage Conditions 2–8°C Same Open Vial Stability 4 hours Same Differences Item Device Predicate Intended Use XN CAL is used for the calibration and calibration verification of the following Sysmex XN series hematology analyzers: XN-
10, XN-11, XN-20, XN-21, and XN-L. XN CAL predicate is NOT cleared for calibration and calibration verification of XN-L analyzers. Closed Vial Stability 35 days 49 days K. Standard/Guidance Document Referenced (if applicable): CLSI H7-A3: Procedure of Determining Packed Cell Volume by the Microhematocrit Method; Approved Standard – Third Edition. CLSI H15-A3: Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard – Third Edition. CLSI H26-A2: Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Approved Standard – Second Edition 4 CLSI EP05-A3: Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline – Third Edition. L. Test Principle: XN CAL was designed to function as a substitute for fresh whole blood to calibrate the Sysmex XN10/20, XN 11/21, and XN-L series hematology analyzers. This product is for in-
vitro diagnostic use to calibrate the following parameters: RBC (106/μL), HGB (g/dL), HCT (%), PLT (103/μL), WBC (103/μL), and RET (%). M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: i. Multi-site reproducibility study: Data was collected from Sysmex XN-L model analyzers at three sites – Streck, Sysmex-Buffalo Grove, and Sysmex-Mundelein with three different operators. Three separately manufactured lots of XN CAL were tested on each analyzer. The study was conducted over the course of 5 days, with three runs per day, and two replicates per run (5 days x 3 runs x 2 replicates x 3 lots x 3 sites). The means for each of the assayed parameters for each lot are indicated in Table 1, below. The total reproducibility estimates (Table 2, below) for each parameter for each lot include the repeatability (within-run), between-
run, between-day, and between-site precision estimates. Results across the three separately manufactured lots of XN CAL demonstrated consistent recovery across multiple instruments, at multiple sites. Table 1: Performance of XN CAL On Three XN-L Analyzers (3 sites) – Mean Values Parameter Mean Lot N WBC RBC HGB HCT PLT RET Lot 6144* 90 7.26 4.36 12.9 36.7 243 2.23 Lot 6172* 90 7.23 4.36 12.3 34.9 246 2.26 Lot 6200* 90 7.32 4.40 12.5 35.4 245 2.20 * = Within lot Table 2: Performance of XN CAL On Three XN-L Analyzers (3 sites) – Variability Estimates Reproducibility Estimates for Each Parameter Lot WBC RBC HGB HCT PLT RET SD %CV SD %CV SD %CV SD %CV SD %CV SD %CV Lot 6144* 0.16 2.2 0.06 1.3 0.1 1.1 0.9 2.3 8 3.1 0.13 5.9 Lot 6172* 0.21 2.9 0.05 1.2 0.1 1.2 0.7 2.1 10 4.1 0.17 7.4 Lot 6200* 0.18 2.4 0.05 1.2 0.1 1.1 0.8 2.3 12 4.7 0.15 7.0 * = Within lot 5 ii. Internal precision study: Performance data provided by the closed-vial stability study was used to support the internal precision study. In this study, performance of three (3) lots of XN CAL was evaluated at one site, on one instrument, for 21 non-consecutive days, two vials per day, and two replicates per vial. The internal precision for each lot of XN CAL was consistent across lots for each assayed parameter (see Tables 3 and 4, below). Total variability estimates (within-lab precision) included repeatability (within-run), between-vial, and between-day (Table 4, below). Table 3: XN CAL Internal Precision Study – Mean Values Parameter Mean Lot N WBC RBC HGB HCT PLT RET Lot 5201* 80 7.28 4.40 11.7 34.5 237 2.48 Lot 5229* 80 7.18 4.44 12.0 35.4 236 2.31 Lot 5257* 80 7.33 4.38 12.1 35.4 232 2.27 * = Within lot Table 4: Within Lab Precision for XN CAL Total variability (within-lab precision) for Each Parameter Lot WBC RBC HGB HCT PLT RET SD %CV SD %CV SD %CV SD %CV SD %CV SD %CV Lot 5201* 0.12 1.7 0.03 0.6 0.1 0.6 0.3 0.8 4 1.9 0.08 3.3 Lot 5229* 0.11 1.6 0.03 0.8 0.1 0.6 0.4 1.0 5 2.3 0.07 3.2 Lot 5257* 0.12 1.6 0.03 0.8 0.1 0.6 0.3 0.7 5 2.0 0.07 3.3 Between Lots 0.08 1.
Proprietary and established names: |
idK160585_s0_e2000 | K160585.txt | regulation section | 21 CFR § 864.8150, Calibrator for cell indices | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K160585 B. Purpose for Submission: To expand the intended use of an existing cleared calibrator (XN CAL; K141962) for use on an additional analyzer, the Sysmex XN-L Analyzer. The XN CAL has previously been cleared for use on other Sysmex XN Series analyzers – the XN-10, XN-11, XN-20, and XN-
21 analyzers. C. Measurand: Assayed hematology parameters: WBC (103/μL), RBC (106/μL), HGB (g/dL), HCT (%), PLT (103/μL), and RET (%) D. Type of Test: Quantitative E. Applicant: Streck, Inc. F. Proprietary and Established Names: XN CAL G. Regulatory Information: 1. Regulation section: 21 CFR § 864.8150, Calibrator for cell indices 2. Classification: Class II 3. Product code: KRX, Calibrator for cell indices 2 4. Panel: Hematology (81) H. Intended Use: 1. Intended use(s): XN CAL is used for the calibration and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. Assayed parameters include: WBC (103/μL), RBC (106/μL), HGB (g/dL), HCT (%), PLT (103/μL), and RET (%). 2. Indication(s) for use: Same as intended use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers I. Device Description: XN CAL is an in-vitro diagnostic product that contains the following: stabilized red blood cell component(s), stabilized white blood cell component(s), stabilized platelet component(s), and stabilized nucleated red blood cell component(s) in a preservative medium. The product is packaged in polypropylene plastic vials with screw caps. The vials will be packaged in five-welled or one-welled vacuum formed clamshell container with the Instructions for Use (IFU) assay sheet. The product must be stored at 2 – 8°C. J. Substantial Equivalence Information: 1. Predicate device name(s): XN CAL 2. Predicate 510(k) number(s): K141962 3. Comparison with predicate: 3 Similarities Item Device Predicate Intended Use XN CAL is used for the calibration and calibration verification of Sysmex XN series hematology analyzers. Assayed parameters include: WBC (103/μL), RBC (106/μL), HGB (g/dL), HCT (%), PLT (103/μL), and RET (%). Same Reagents XN CAL contains the following: stabilized red blood cell component(s), stabilized white blood cell component(s), stabilized platelet component(s), and stabilized nucleated red blood cell component(s) in a preservative medium. Same Storage Conditions 2–8°C Same Open Vial Stability 4 hours Same Differences Item Device Predicate Intended Use XN CAL is used for the calibration and calibration verification of the following Sysmex XN series hematology analyzers: XN-
10, XN-11, XN-20, XN-21, and XN-L. XN CAL predicate is NOT cleared for calibration and calibration verification of XN-L analyzers. Closed Vial Stability 35 days 49 days K. Standard/Guidance Document Referenced (if applicable): CLSI H7-A3: Procedure of Determining Packed Cell Volume by the Microhematocrit Method; Approved Standard – Third Edition. CLSI H15-A3: Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard – Third Edition. CLSI H26-A2: Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Approved Standard – Second Edition 4 CLSI EP05-A3: Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline – Third Edition. L. Test Principle: XN CAL was designed to function as a substitute for fresh whole blood to calibrate the Sysmex XN10/20, XN 11/21, and XN-L series hematology analyzers. This product is for in-
vitro diagnostic use to calibrate the following parameters: RBC (106/μL), HGB (g/dL), HCT (%), PLT (103/μL), WBC (103/μL), and RET (%). M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: i. Multi-site reproducibility study: Data was collected from Sysmex XN-L model analyzers at three sites – Streck, Sysmex-Buffalo Grove, and Sysmex-Mundelein with three different operators. Three separately manufactured lots of XN CAL were tested on each analyzer. The study was conducted over the course of 5 days, with three runs per day, and two replicates per run (5 days x 3 runs x 2 replicates x 3 lots x 3 sites). The means for each of the assayed parameters for each lot are indicated in Table 1, below. The total reproducibility estimates (Table 2, below) for each parameter for each lot include the repeatability (within-run), between-
run, between-day, and between-site precision estimates. Results across the three separately manufactured lots of XN CAL demonstrated consistent recovery across multiple instruments, at multiple sites. Table 1: Performance of XN CAL On Three XN-L Analyzers (3 sites) – Mean Values Parameter Mean Lot N WBC RBC HGB HCT PLT RET Lot 6144* 90 7.26 4.36 12.9 36.7 243 2.23 Lot 6172* 90 7.23 4.36 12.3 34.9 246 2.26 Lot 6200* 90 7.32 4.40 12.5 35.4 245 2.20 * = Within lot Table 2: Performance of XN CAL On Three XN-L Analyzers (3 sites) – Variability Estimates Reproducibility Estimates for Each Parameter Lot WBC RBC HGB HCT PLT RET SD %CV SD %CV SD %CV SD %CV SD %CV SD %CV Lot 6144* 0.16 2.2 0.06 1.3 0.1 1.1 0.9 2.3 8 3.1 0.13 5.9 Lot 6172* 0.21 2.9 0.05 1.2 0.1 1.2 0.7 2.1 10 4.1 0.17 7.4 Lot 6200* 0.18 2.4 0.05 1.2 0.1 1.1 0.8 2.3 12 4.7 0.15 7.0 * = Within lot 5 ii. Internal precision study: Performance data provided by the closed-vial stability study was used to support the internal precision study. In this study, performance of three (3) lots of XN CAL was evaluated at one site, on one instrument, for 21 non-consecutive days, two vials per day, and two replicates per vial. The internal precision for each lot of XN CAL was consistent across lots for each assayed parameter (see Tables 3 and 4, below). Total variability estimates (within-lab precision) included repeatability (within-run), between-vial, and between-day (Table 4, below). Table 3: XN CAL Internal Precision Study – Mean Values Parameter Mean Lot N WBC RBC HGB HCT PLT RET Lot 5201* 80 7.28 4.40 11.7 34.5 237 2.48 Lot 5229* 80 7.18 4.44 12.0 35.4 236 2.31 Lot 5257* 80 7.33 4.38 12.1 35.4 232 2.27 * = Within lot Table 4: Within Lab Precision for XN CAL Total variability (within-lab precision) for Each Parameter Lot WBC RBC HGB HCT PLT RET SD %CV SD %CV SD %CV SD %CV SD %CV SD %CV Lot 5201* 0.12 1.7 0.03 0.6 0.1 0.6 0.3 0.8 4 1.9 0.08 3.3 Lot 5229* 0.11 1.6 0.03 0.8 0.1 0.6 0.4 1.0 5 2.3 0.07 3.2 Lot 5257* 0.12 1.6 0.03 0.8 0.1 0.6 0.3 0.7 5 2.0 0.07 3.3 Between Lots 0.08 1.
Regulation section: |
idK160585_s2000_e4000 | K160585.txt | proposed labeling | The provided labeling is sufficient and satisfies the requirements of 21 CFR Part 809.10. | .8 0.2 1.8 0.5 1.5 3 1.2 0.11 4.7 * = Within lot b. Linearity/assay reportable range: Not applicable c. Traceability, Stability, Expected values (controls, calibrators, or methods): Value Assignment: Value assignment for the three lots of XN CAL evaluated in this submission was based on data collected across three XN-L instruments at three sites. Data was collected across three separately manufactured lots over the course of 5 non-
consecutive days, with three (3) runs per day, and two (2) replicates per run. All assay ranges assigned to each lot for each of the parameters are based on the total reproducibility estimated from the multi-site reproducibility study. Assay values were assigned to the following parameters: RBC (106/μL), HGB (g/dL), HCT (%), PLT (103/μL), WBC (103/μL), and RET (%). Future lots of XN CAL will be value assigned at one site by a minimum of one operator. Five repeat measurements will be taken from two separate vials of calibrator and assayed in a single run on each of the 2 days. The average of the 20 individual measurements will be used for value assignment. All lot specific assay values will be included on the lot specific assay 6 sheet for each manufactured lot of control. This assay sheet will be included in each product package. Instruments at Streck are whole blood calibrated as per CLSI H26-
A2 and the individual parameters are traceable to reference methods found in CLSI H7-A3, CLSI H15-A3, and ICSH Expert Panel on Cytometry publications (Clin. Lab. Haemat. 1998. v10, 203-212; and Am. J. Clin. Pathol. 2001. v115, 460-464). Traceability: The instruments maintained at Streck and used for value assignment for XN CAL measurands were calibrated with whole blood in accordance with CLSI H26-A2 “Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Approved Standard – Second Edition,” and are traceable to the following reference methods: · WBC and RBC: Reference method for the enumeration of erythrocytes and leucocytes, ICSH Expert Panel on Cytometry, Clin Lab Haematol. 1994; 16, 131-138. Counts are performed on SCC (Semi-automated Single Channel counter), a volumetric manometer semi-automated electronic impedance cell counter. · HGB: Recommendation for reference method for haemoglobinometry in human blood (ICSH standard 1995) and specification for international haemiglobincyanide standard (4th edition), ICSH Expert Panel on Haemoglobinometry, J Clin Pathol 1996; 49: 271-274. · HCT: Recommendations for Reference Method for the Packed Cell Volume (ICSH Standard 2001), ICSH Expert Panel on Cytometry, Clin Lab Hematol. 2001; 7:148-170. · PLT: Platelet count values are determined by using a Neubauer Improved hemacytometer counting chamber and the bioanalytic® GmbH Thrombo-tic® PLT counting kit. This method is based on the procedure developed by Brecher and Cronkite. · RET%: Methods for Reticulocyte Counting (Automated Blood Cell Counters, Flow Cytometry, and Supravital Dyes); Approved Guideline – Second Edition Manual method CLSI H44-A2. · CLSI Document H15-A3, Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood, December, 2000. Reagent Stability: i. Open-vial stability: A 4-hour real-time open-vial stability study was conducted at one site on the XN-L model analyzer. Throughout the collection of the open-
vial stability data, the calibrator was stored as indicated in the instructions for use. Each vial was stored at 2–8°C and removed for testing. After testing, the vial was returned to 2–8°C until the next testing event. One vial of calibrator from each of the three lots was analyzed in four replicates on one day over a period of 5 hours (times 0, 2, 4, and 5 hours; n=16 measurements), on one analyzer. Stability performance of each lot of calibrator was assessed in terms of 7 parameter drift over time (for each parameter), as described in CLSI EP25-A – “Evaluation of Stability of In Vitro Diagnostic Agents; Approved Guideline.” Values associated with each parameter, for each lot, and at each time point were within the acceptable value range, supportive of a 4-hour open vial stability claim. ii. Closed-vial stability: A real-time, 35-day closed-vial study was conducted internally on one Sysmex XN-L model analyzer by one operator. Two vials of calibrators from each of the three lots were analyzed in duplicate over the course of 38–39 days (with data collected every 4 days), providing measurements for 21 non-consecutive days. Stability performance of each lot of calibrator was assessed in terms of parameter drift over time (for each parameter), as described in CLSI EP25-A – “Evaluation of Stability of In Vitro Diagnostic Agents; Approved Guideline.” Values associated with each parameter, for each lot, and at each time point were within the acceptable value range, supportive of a 35-day closed-vial stability claim. d. Detection limit: Not applicable e. Analytical specificity: Not applicable f. Assay cut-off: Not applicable 2. Comparison studies: a. Method comparison with predicate device: Not applicable b. Matrix comparison: Not applicable 3. Clinical studies: a. Clinical Sensitivity: Not applicable b. Clinical specificity: 8 Not applicable c. Other clinical supportive data (when a. and b. are not applicable): Not applicable 4. Clinical cut-off: Not applicable 5. Expected values/Reference range: All lot specific assay values will be included on the lot specific assay sheet for each manufactured lot of calibrators. This assay sheet will be included in each product package. N. Proposed Labeling: The provided labeling is sufficient and satisfies the requirements of 21 CFR Part 809.10. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
Proposed labeling: |
idK160585_s2000_e4000 | K160585.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | 03 0.8 0.2 1.8 0.5 1.5 3 1.2 0.11 4.7 * = Within lot b. Linearity/assay reportable range: Not applicable c. Traceability, Stability, Expected values (controls, calibrators, or methods): Value Assignment: Value assignment for the three lots of XN CAL evaluated in this submission was based on data collected across three XN-L instruments at three sites. Data was collected across three separately manufactured lots over the course of 5 non-
consecutive days, with three (3) runs per day, and two (2) replicates per run. All assay ranges assigned to each lot for each of the parameters are based on the total reproducibility estimated from the multi-site reproducibility study. Assay values were assigned to the following parameters: RBC (106/μL), HGB (g/dL), HCT (%), PLT (103/μL), WBC (103/μL), and RET (%). Future lots of XN CAL will be value assigned at one site by a minimum of one operator. Five repeat measurements will be taken from two separate vials of calibrator and assayed in a single run on each of the 2 days. The average of the 20 individual measurements will be used for value assignment. All lot specific assay values will be included on the lot specific assay 6 sheet for each manufactured lot of control. This assay sheet will be included in each product package. Instruments at Streck are whole blood calibrated as per CLSI H26-
A2 and the individual parameters are traceable to reference methods found in CLSI H7-A3, CLSI H15-A3, and ICSH Expert Panel on Cytometry publications (Clin. Lab. Haemat. 1998. v10, 203-212; and Am. J. Clin. Pathol. 2001. v115, 460-464). Traceability: The instruments maintained at Streck and used for value assignment for XN CAL measurands were calibrated with whole blood in accordance with CLSI H26-A2 “Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Approved Standard – Second Edition,” and are traceable to the following reference methods: · WBC and RBC: Reference method for the enumeration of erythrocytes and leucocytes, ICSH Expert Panel on Cytometry, Clin Lab Haematol. 1994; 16, 131-138. Counts are performed on SCC (Semi-automated Single Channel counter), a volumetric manometer semi-automated electronic impedance cell counter. · HGB: Recommendation for reference method for haemoglobinometry in human blood (ICSH standard 1995) and specification for international haemiglobincyanide standard (4th edition), ICSH Expert Panel on Haemoglobinometry, J Clin Pathol 1996; 49: 271-274. · HCT: Recommendations for Reference Method for the Packed Cell Volume (ICSH Standard 2001), ICSH Expert Panel on Cytometry, Clin Lab Hematol. 2001; 7:148-170. · PLT: Platelet count values are determined by using a Neubauer Improved hemacytometer counting chamber and the bioanalytic® GmbH Thrombo-tic® PLT counting kit. This method is based on the procedure developed by Brecher and Cronkite. · RET%: Methods for Reticulocyte Counting (Automated Blood Cell Counters, Flow Cytometry, and Supravital Dyes); Approved Guideline – Second Edition Manual method CLSI H44-A2. · CLSI Document H15-A3, Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood, December, 2000. Reagent Stability: i. Open-vial stability: A 4-hour real-time open-vial stability study was conducted at one site on the XN-L model analyzer. Throughout the collection of the open-
vial stability data, the calibrator was stored as indicated in the instructions for use. Each vial was stored at 2–8°C and removed for testing. After testing, the vial was returned to 2–8°C until the next testing event. One vial of calibrator from each of the three lots was analyzed in four replicates on one day over a period of 5 hours (times 0, 2, 4, and 5 hours; n=16 measurements), on one analyzer. Stability performance of each lot of calibrator was assessed in terms of 7 parameter drift over time (for each parameter), as described in CLSI EP25-A – “Evaluation of Stability of In Vitro Diagnostic Agents; Approved Guideline.” Values associated with each parameter, for each lot, and at each time point were within the acceptable value range, supportive of a 4-hour open vial stability claim. ii. Closed-vial stability: A real-time, 35-day closed-vial study was conducted internally on one Sysmex XN-L model analyzer by one operator. Two vials of calibrators from each of the three lots were analyzed in duplicate over the course of 38–39 days (with data collected every 4 days), providing measurements for 21 non-consecutive days. Stability performance of each lot of calibrator was assessed in terms of parameter drift over time (for each parameter), as described in CLSI EP25-A – “Evaluation of Stability of In Vitro Diagnostic Agents; Approved Guideline.” Values associated with each parameter, for each lot, and at each time point were within the acceptable value range, supportive of a 35-day closed-vial stability claim. d. Detection limit: Not applicable e. Analytical specificity: Not applicable f. Assay cut-off: Not applicable 2. Comparison studies: a. Method comparison with predicate device: Not applicable b. Matrix comparison: Not applicable 3. Clinical studies: a. Clinical Sensitivity: Not applicable b. Clinical specificity: 8 Not applicable c. Other clinical supportive data (when a. and b. are not applicable): Not applicable 4. Clinical cut-off: Not applicable 5. Expected values/Reference range: All lot specific assay values will be included on the lot specific assay sheet for each manufactured lot of calibrators. This assay sheet will be included in each product package. N. Proposed Labeling: The provided labeling is sufficient and satisfies the requirements of 21 CFR Part 809.10. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
Conclusion: |
idK180607_s0_e2000 | K180607.txt | purpose for submission | New device | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K180607 B. Purpose for Submission: New device C. Measurand: Steroid 21-Hydroxylase Antibody (21-OHAb) D. Type of Test: Manual�enzyme-linked� immunosorbent� assay,�qualitative E. Applicant: KRONUS�Market�Development� Associates,�INC.�
F. Proprietary and Established Names: KRONUS�Steroid� 21-Hydroxylase� Autoantibody� (21-OHAb)�ELISA�Kit G. Regulatory Information: 1.� Regulation� section:�
21�CFR�§�866.5660,� Multiple� autoantibody� immunological� test�system�
2.� Classification:�
Class�II�
3. Product�code:�
PCG,�21-Hydroxylase� Antibody� (21-OHAb)�antibody� assay�
4.� Panel:�
Immunology� (82)�
2
H. Intended Use: 1. Intended use: The KRONUS Steroid 21-Hydroxylase Autoantibody (21-OHAb) ELISA Kit is for the qualitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum. The Steroid 21-Hydroxylase Autoantibody (21-OHAb) ELISA Kit is useful as an aid in the diagnosis of autoimmune adrenal disease, whether expressed as autoimmune Addison's disease (isolated) or Addison's disease as part of the more complex autoimmune polyglandular syndrome (APS), type I or II. The assay result is to be used in conjunction with other clinical and laboratory findings and is not a substitute for functional testing required to diagnose adrenal insufficiency. 2. Indication for use: Same as intended use 3. Special conditions for use statement: For prescription use only. 4. Special instrument requirements: Microtiter plate reader capable of measuring a 96 well plate at 405 nm I. Device Description: The�KRONUS�Steroid� 21-Hydroxylase�Autoantibody� (21-OHAb)�ELISA�Kit�consists�
of�the�following� components:�
1. Recombinant� human�21-OHAb-coated�ELISA�strip�wells,� 96�wells�in�total�and�
supplied� as�12�strips�of�eight� wells�in�a�frame�and�sealed�in�a�foil� pouch�with�
desiccant�
2. Reference�Preparation,1�x�0.7�mL�(ready�to�use)�
3. Kit�Negative�Control,1� x�0.7�mL�(ready�to�use)�
4. Kit�Positive�Control� 1�and�2�(see�label�for�ranges),�2�x�0.7�mL�(ready�to�use)�
5. 21-OH�Reaction�Enhancer�(colored�red),�1�x�6�mL�(ready�to�use)�
6. 21-OH�Biotin� (lyophilized),� 3�x�5.5�mL�(reconstitute�immediately� prior�to�use)�
7. 21-OH�Biotin� Reconstitution� Buffer,�2�x�10�mL�(ready�to�use)�
8. Streptavidin� Peroxidase�(SA-POD),�1�x�0.7�mL�(dilute� SA-POD�1:20� before�use)�
9. Streptavidin-Peroxidase� Diluent,� 1�x�15�mL�(ready�to�use)�
10. Tetramethylbenzidine� Peroxidase�Substrate�(TMB),�1�x�15�mL�(ready�to�use)�
11. Stop�solution� (contains�0.25M�H2SO4),�1�x�12�mL�(ready-to-use)�
12. Concentrated�Wash�Solution� 1�x�125�mL�(dilute�1:10� with�deionized� water�before�
use)�
3
J. Substantial Equivalence Information: 1. Predicate device name and 510(k) number: KRONUS 21-OHAb RIA Assay Kit (K121046) 2. Comparison with predicate(s): Similarities Item Candidate Device KRONUS 21-OHAb ELISA Kit Predicate Device KRONUS 21-OHAb RIA Assay Kit Intended Use The KRONUS Steroid 21-
Hydroxylase Autoantibody (21-
OHAb) ELISA Kit is for the qualitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum. The Steroid 21-Hydroxylase Autoantibody (21-
OHAb) ELISA Kit is useful as an aid in the diagnosis of autoimmune adrenal disease, whether expressed as autoimmune Addison's disease (isolated) or Addison's disease as part of the more complex autoimmune polyglandular syndrome (APS), type I or II. The assay result is to be used in conjunction with other clinical and laboratory findings and is not a substitute for functional testing required to diagnose adrenal insufficiency. Same Analyte Steroid 21-Hydroxylase autoantibodies Same Sample Matrix Serum Same Incubation time Overnight (16–20 hours) Same Differences Item Candidate Device KRONUS 21-OHAb ELISA Kit Predicate Device KRONUS 21-OHAb RIA Assay Kit Methodology Autoantibodies to 21-OH bind to 21-
OH -biotin, are detected by a colorimetric reaction with streptavidin-peroxidase and Autoantibodies to 21-OH react with I125-labeled 21-OH tracer, are precipitated with Protein A, and read off a 4
Differences
Item
Candidate Device
KRONUS 21-OHAb ELISA Kit
Predicate Device KRONUS 21-OHAb RIA Assay Kit
tetramethyl benzidine and read off a reference preparation calibration curve Method/Principle Enzyme-linked immunosorbent assay (ELISA) Radioimmunoassay (RIA) Assay format Qualitative Semi-quantitative Detection Equipment Plate Reader Gamma counter Cut-off Positive:� ≥�45 Negative: < 45 Positive: > 1 U/mL Negative:�≤�1�U/mL K. Standard/Guidance Document Referenced (if applicable): · CLSI guideline EP12-A2, User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline–Second Edition · CLSI guideline EP07-A2, Interference Testing in Clinical Chemistry - Second Edition · CLSI guideline C28-A3c, Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline- Third Edition L. Test Principle: The KRONUS Steroid 21-Hydroxylase Autoantibody (21-OHAb) ELISA Kit depends on the divalent properties of the Steroid 21-Hydroxylase autoantibodies (21-OHAb) to form a bridge between 21-OH coated on ELISA plate wells and liquid phase 21-OH-
biotin. The level of bound 21-OHAb is then quantitated by the sequential addition of streptavidin peroxidase (SA-POD) and tetramethylbenzidine (TMB; a chromogenic substrate) to produce a colorogenic reaction. Stop solution is added to halt the reaction and absorbance is read using an ELISA plate reader with absorbance at 450 nm. The absorbance of each specimen is compared to the reference preparation, allowing for an index value to be calculated from the mean value of duplicate wells as follows: Index = test sample absorbance at 450 nm x 100 reference preparation absorbance at 450 nm Results are reported as “Negative”, “Positive”, or “Indeterminate”. A specimen with an index value equal to or greater than the specified cut-off (i.e. ≥45) is considered positive for antibodies against 21-OH while an index value below this cut-off (i.e. <45) is considered negative for 21-OH antibodies. 5
Index values are calculated from the mean of duplicates. Results can be considered valid determinations if sample replicates yield the same clinical interpretation (i.e. both replicates�have�index� values�that�are�<45�or�≥45)�and�coefficient�of�variation� does�not�
exceed 20% for determinations calculated from duplicates with at least one index value in the range
Purpose for submission: |
idK180607_s0_e2000 | K180607.txt | measurand | Steroid 21-Hydroxylase Antibody (21-OHAb) | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K180607 B. Purpose for Submission: New device C. Measurand: Steroid 21-Hydroxylase Antibody (21-OHAb) D. Type of Test: Manual�enzyme-linked� immunosorbent� assay,�qualitative E. Applicant: KRONUS�Market�Development� Associates,�INC.�
F. Proprietary and Established Names: KRONUS�Steroid� 21-Hydroxylase� Autoantibody� (21-OHAb)�ELISA�Kit G. Regulatory Information: 1.� Regulation� section:�
21�CFR�§�866.5660,� Multiple� autoantibody� immunological� test�system�
2.� Classification:�
Class�II�
3. Product�code:�
PCG,�21-Hydroxylase� Antibody� (21-OHAb)�antibody� assay�
4.� Panel:�
Immunology� (82)�
2
H. Intended Use: 1. Intended use: The KRONUS Steroid 21-Hydroxylase Autoantibody (21-OHAb) ELISA Kit is for the qualitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum. The Steroid 21-Hydroxylase Autoantibody (21-OHAb) ELISA Kit is useful as an aid in the diagnosis of autoimmune adrenal disease, whether expressed as autoimmune Addison's disease (isolated) or Addison's disease as part of the more complex autoimmune polyglandular syndrome (APS), type I or II. The assay result is to be used in conjunction with other clinical and laboratory findings and is not a substitute for functional testing required to diagnose adrenal insufficiency. 2. Indication for use: Same as intended use 3. Special conditions for use statement: For prescription use only. 4. Special instrument requirements: Microtiter plate reader capable of measuring a 96 well plate at 405 nm I. Device Description: The�KRONUS�Steroid� 21-Hydroxylase�Autoantibody� (21-OHAb)�ELISA�Kit�consists�
of�the�following� components:�
1. Recombinant� human�21-OHAb-coated�ELISA�strip�wells,� 96�wells�in�total�and�
supplied� as�12�strips�of�eight� wells�in�a�frame�and�sealed�in�a�foil� pouch�with�
desiccant�
2. Reference�Preparation,1�x�0.7�mL�(ready�to�use)�
3. Kit�Negative�Control,1� x�0.7�mL�(ready�to�use)�
4. Kit�Positive�Control� 1�and�2�(see�label�for�ranges),�2�x�0.7�mL�(ready�to�use)�
5. 21-OH�Reaction�Enhancer�(colored�red),�1�x�6�mL�(ready�to�use)�
6. 21-OH�Biotin� (lyophilized),� 3�x�5.5�mL�(reconstitute�immediately� prior�to�use)�
7. 21-OH�Biotin� Reconstitution� Buffer,�2�x�10�mL�(ready�to�use)�
8. Streptavidin� Peroxidase�(SA-POD),�1�x�0.7�mL�(dilute� SA-POD�1:20� before�use)�
9. Streptavidin-Peroxidase� Diluent,� 1�x�15�mL�(ready�to�use)�
10. Tetramethylbenzidine� Peroxidase�Substrate�(TMB),�1�x�15�mL�(ready�to�use)�
11. Stop�solution� (contains�0.25M�H2SO4),�1�x�12�mL�(ready-to-use)�
12. Concentrated�Wash�Solution� 1�x�125�mL�(dilute�1:10� with�deionized� water�before�
use)�
3
J. Substantial Equivalence Information: 1. Predicate device name and 510(k) number: KRONUS 21-OHAb RIA Assay Kit (K121046) 2. Comparison with predicate(s): Similarities Item Candidate Device KRONUS 21-OHAb ELISA Kit Predicate Device KRONUS 21-OHAb RIA Assay Kit Intended Use The KRONUS Steroid 21-
Hydroxylase Autoantibody (21-
OHAb) ELISA Kit is for the qualitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum. The Steroid 21-Hydroxylase Autoantibody (21-
OHAb) ELISA Kit is useful as an aid in the diagnosis of autoimmune adrenal disease, whether expressed as autoimmune Addison's disease (isolated) or Addison's disease as part of the more complex autoimmune polyglandular syndrome (APS), type I or II. The assay result is to be used in conjunction with other clinical and laboratory findings and is not a substitute for functional testing required to diagnose adrenal insufficiency. Same Analyte Steroid 21-Hydroxylase autoantibodies Same Sample Matrix Serum Same Incubation time Overnight (16–20 hours) Same Differences Item Candidate Device KRONUS 21-OHAb ELISA Kit Predicate Device KRONUS 21-OHAb RIA Assay Kit Methodology Autoantibodies to 21-OH bind to 21-
OH -biotin, are detected by a colorimetric reaction with streptavidin-peroxidase and Autoantibodies to 21-OH react with I125-labeled 21-OH tracer, are precipitated with Protein A, and read off a 4
Differences
Item
Candidate Device
KRONUS 21-OHAb ELISA Kit
Predicate Device KRONUS 21-OHAb RIA Assay Kit
tetramethyl benzidine and read off a reference preparation calibration curve Method/Principle Enzyme-linked immunosorbent assay (ELISA) Radioimmunoassay (RIA) Assay format Qualitative Semi-quantitative Detection Equipment Plate Reader Gamma counter Cut-off Positive:� ≥�45 Negative: < 45 Positive: > 1 U/mL Negative:�≤�1�U/mL K. Standard/Guidance Document Referenced (if applicable): · CLSI guideline EP12-A2, User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline–Second Edition · CLSI guideline EP07-A2, Interference Testing in Clinical Chemistry - Second Edition · CLSI guideline C28-A3c, Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline- Third Edition L. Test Principle: The KRONUS Steroid 21-Hydroxylase Autoantibody (21-OHAb) ELISA Kit depends on the divalent properties of the Steroid 21-Hydroxylase autoantibodies (21-OHAb) to form a bridge between 21-OH coated on ELISA plate wells and liquid phase 21-OH-
biotin. The level of bound 21-OHAb is then quantitated by the sequential addition of streptavidin peroxidase (SA-POD) and tetramethylbenzidine (TMB; a chromogenic substrate) to produce a colorogenic reaction. Stop solution is added to halt the reaction and absorbance is read using an ELISA plate reader with absorbance at 450 nm. The absorbance of each specimen is compared to the reference preparation, allowing for an index value to be calculated from the mean value of duplicate wells as follows: Index = test sample absorbance at 450 nm x 100 reference preparation absorbance at 450 nm Results are reported as “Negative”, “Positive”, or “Indeterminate”. A specimen with an index value equal to or greater than the specified cut-off (i.e. ≥45) is considered positive for antibodies against 21-OH while an index value below this cut-off (i.e. <45) is considered negative for 21-OH antibodies. 5
Index values are calculated from the mean of duplicates. Results can be considered valid determinations if sample replicates yield the same clinical interpretation (i.e. both replicates�have�index� values�that�are�<45�or�≥45)�and�coefficient�of�variation� does�not�
exceed 20% for determinations calculated from duplicates with at least one index value in the range
Measurand: |
idK180607_s0_e2000 | K180607.txt | type of test | Manual�enzyme-linked� immunosorbent� assay,�qualitative | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K180607 B. Purpose for Submission: New device C. Measurand: Steroid 21-Hydroxylase Antibody (21-OHAb) D. Type of Test: Manual�enzyme-linked� immunosorbent� assay,�qualitative E. Applicant: KRONUS�Market�Development� Associates,�INC.�
F. Proprietary and Established Names: KRONUS�Steroid� 21-Hydroxylase� Autoantibody� (21-OHAb)�ELISA�Kit G. Regulatory Information: 1.� Regulation� section:�
21�CFR�§�866.5660,� Multiple� autoantibody� immunological� test�system�
2.� Classification:�
Class�II�
3. Product�code:�
PCG,�21-Hydroxylase� Antibody� (21-OHAb)�antibody� assay�
4.� Panel:�
Immunology� (82)�
2
H. Intended Use: 1. Intended use: The KRONUS Steroid 21-Hydroxylase Autoantibody (21-OHAb) ELISA Kit is for the qualitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum. The Steroid 21-Hydroxylase Autoantibody (21-OHAb) ELISA Kit is useful as an aid in the diagnosis of autoimmune adrenal disease, whether expressed as autoimmune Addison's disease (isolated) or Addison's disease as part of the more complex autoimmune polyglandular syndrome (APS), type I or II. The assay result is to be used in conjunction with other clinical and laboratory findings and is not a substitute for functional testing required to diagnose adrenal insufficiency. 2. Indication for use: Same as intended use 3. Special conditions for use statement: For prescription use only. 4. Special instrument requirements: Microtiter plate reader capable of measuring a 96 well plate at 405 nm I. Device Description: The�KRONUS�Steroid� 21-Hydroxylase�Autoantibody� (21-OHAb)�ELISA�Kit�consists�
of�the�following� components:�
1. Recombinant� human�21-OHAb-coated�ELISA�strip�wells,� 96�wells�in�total�and�
supplied� as�12�strips�of�eight� wells�in�a�frame�and�sealed�in�a�foil� pouch�with�
desiccant�
2. Reference�Preparation,1�x�0.7�mL�(ready�to�use)�
3. Kit�Negative�Control,1� x�0.7�mL�(ready�to�use)�
4. Kit�Positive�Control� 1�and�2�(see�label�for�ranges),�2�x�0.7�mL�(ready�to�use)�
5. 21-OH�Reaction�Enhancer�(colored�red),�1�x�6�mL�(ready�to�use)�
6. 21-OH�Biotin� (lyophilized),� 3�x�5.5�mL�(reconstitute�immediately� prior�to�use)�
7. 21-OH�Biotin� Reconstitution� Buffer,�2�x�10�mL�(ready�to�use)�
8. Streptavidin� Peroxidase�(SA-POD),�1�x�0.7�mL�(dilute� SA-POD�1:20� before�use)�
9. Streptavidin-Peroxidase� Diluent,� 1�x�15�mL�(ready�to�use)�
10. Tetramethylbenzidine� Peroxidase�Substrate�(TMB),�1�x�15�mL�(ready�to�use)�
11. Stop�solution� (contains�0.25M�H2SO4),�1�x�12�mL�(ready-to-use)�
12. Concentrated�Wash�Solution� 1�x�125�mL�(dilute�1:10� with�deionized� water�before�
use)�
3
J. Substantial Equivalence Information: 1. Predicate device name and 510(k) number: KRONUS 21-OHAb RIA Assay Kit (K121046) 2. Comparison with predicate(s): Similarities Item Candidate Device KRONUS 21-OHAb ELISA Kit Predicate Device KRONUS 21-OHAb RIA Assay Kit Intended Use The KRONUS Steroid 21-
Hydroxylase Autoantibody (21-
OHAb) ELISA Kit is for the qualitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum. The Steroid 21-Hydroxylase Autoantibody (21-
OHAb) ELISA Kit is useful as an aid in the diagnosis of autoimmune adrenal disease, whether expressed as autoimmune Addison's disease (isolated) or Addison's disease as part of the more complex autoimmune polyglandular syndrome (APS), type I or II. The assay result is to be used in conjunction with other clinical and laboratory findings and is not a substitute for functional testing required to diagnose adrenal insufficiency. Same Analyte Steroid 21-Hydroxylase autoantibodies Same Sample Matrix Serum Same Incubation time Overnight (16–20 hours) Same Differences Item Candidate Device KRONUS 21-OHAb ELISA Kit Predicate Device KRONUS 21-OHAb RIA Assay Kit Methodology Autoantibodies to 21-OH bind to 21-
OH -biotin, are detected by a colorimetric reaction with streptavidin-peroxidase and Autoantibodies to 21-OH react with I125-labeled 21-OH tracer, are precipitated with Protein A, and read off a 4
Differences
Item
Candidate Device
KRONUS 21-OHAb ELISA Kit
Predicate Device KRONUS 21-OHAb RIA Assay Kit
tetramethyl benzidine and read off a reference preparation calibration curve Method/Principle Enzyme-linked immunosorbent assay (ELISA) Radioimmunoassay (RIA) Assay format Qualitative Semi-quantitative Detection Equipment Plate Reader Gamma counter Cut-off Positive:� ≥�45 Negative: < 45 Positive: > 1 U/mL Negative:�≤�1�U/mL K. Standard/Guidance Document Referenced (if applicable): · CLSI guideline EP12-A2, User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline–Second Edition · CLSI guideline EP07-A2, Interference Testing in Clinical Chemistry - Second Edition · CLSI guideline C28-A3c, Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline- Third Edition L. Test Principle: The KRONUS Steroid 21-Hydroxylase Autoantibody (21-OHAb) ELISA Kit depends on the divalent properties of the Steroid 21-Hydroxylase autoantibodies (21-OHAb) to form a bridge between 21-OH coated on ELISA plate wells and liquid phase 21-OH-
biotin. The level of bound 21-OHAb is then quantitated by the sequential addition of streptavidin peroxidase (SA-POD) and tetramethylbenzidine (TMB; a chromogenic substrate) to produce a colorogenic reaction. Stop solution is added to halt the reaction and absorbance is read using an ELISA plate reader with absorbance at 450 nm. The absorbance of each specimen is compared to the reference preparation, allowing for an index value to be calculated from the mean value of duplicate wells as follows: Index = test sample absorbance at 450 nm x 100 reference preparation absorbance at 450 nm Results are reported as “Negative”, “Positive”, or “Indeterminate”. A specimen with an index value equal to or greater than the specified cut-off (i.e. ≥45) is considered positive for antibodies against 21-OH while an index value below this cut-off (i.e. <45) is considered negative for 21-OH antibodies. 5
Index values are calculated from the mean of duplicates. Results can be considered valid determinations if sample replicates yield the same clinical interpretation (i.e. both replicates�have�index� values�that�are�<45�or�≥45)�and�coefficient�of�variation� does�not�
exceed 20% for determinations calculated from duplicates with at least one index value in the range
Type of test: |
idK180607_s0_e2000 | K180607.txt | classification | I | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K180607 B. Purpose for Submission: New device C. Measurand: Steroid 21-Hydroxylase Antibody (21-OHAb) D. Type of Test: Manual�enzyme-linked� immunosorbent� assay,�qualitative E. Applicant: KRONUS�Market�Development� Associates,�INC.�
F. Proprietary and Established Names: KRONUS�Steroid� 21-Hydroxylase� Autoantibody� (21-OHAb)�ELISA�Kit G. Regulatory Information: 1.� Regulation� section:�
21�CFR�§�866.5660,� Multiple� autoantibody� immunological� test�system�
2.� Classification:�
Class�II�
3. Product�code:�
PCG,�21-Hydroxylase� Antibody� (21-OHAb)�antibody� assay�
4.� Panel:�
Immunology� (82)�
2
H. Intended Use: 1. Intended use: The KRONUS Steroid 21-Hydroxylase Autoantibody (21-OHAb) ELISA Kit is for the qualitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum. The Steroid 21-Hydroxylase Autoantibody (21-OHAb) ELISA Kit is useful as an aid in the diagnosis of autoimmune adrenal disease, whether expressed as autoimmune Addison's disease (isolated) or Addison's disease as part of the more complex autoimmune polyglandular syndrome (APS), type I or II. The assay result is to be used in conjunction with other clinical and laboratory findings and is not a substitute for functional testing required to diagnose adrenal insufficiency. 2. Indication for use: Same as intended use 3. Special conditions for use statement: For prescription use only. 4. Special instrument requirements: Microtiter plate reader capable of measuring a 96 well plate at 405 nm I. Device Description: The�KRONUS�Steroid� 21-Hydroxylase�Autoantibody� (21-OHAb)�ELISA�Kit�consists�
of�the�following� components:�
1. Recombinant� human�21-OHAb-coated�ELISA�strip�wells,� 96�wells�in�total�and�
supplied� as�12�strips�of�eight� wells�in�a�frame�and�sealed�in�a�foil� pouch�with�
desiccant�
2. Reference�Preparation,1�x�0.7�mL�(ready�to�use)�
3. Kit�Negative�Control,1� x�0.7�mL�(ready�to�use)�
4. Kit�Positive�Control� 1�and�2�(see�label�for�ranges),�2�x�0.7�mL�(ready�to�use)�
5. 21-OH�Reaction�Enhancer�(colored�red),�1�x�6�mL�(ready�to�use)�
6. 21-OH�Biotin� (lyophilized),� 3�x�5.5�mL�(reconstitute�immediately� prior�to�use)�
7. 21-OH�Biotin� Reconstitution� Buffer,�2�x�10�mL�(ready�to�use)�
8. Streptavidin� Peroxidase�(SA-POD),�1�x�0.7�mL�(dilute� SA-POD�1:20� before�use)�
9. Streptavidin-Peroxidase� Diluent,� 1�x�15�mL�(ready�to�use)�
10. Tetramethylbenzidine� Peroxidase�Substrate�(TMB),�1�x�15�mL�(ready�to�use)�
11. Stop�solution� (contains�0.25M�H2SO4),�1�x�12�mL�(ready-to-use)�
12. Concentrated�Wash�Solution� 1�x�125�mL�(dilute�1:10� with�deionized� water�before�
use)�
3
J. Substantial Equivalence Information: 1. Predicate device name and 510(k) number: KRONUS 21-OHAb RIA Assay Kit (K121046) 2. Comparison with predicate(s): Similarities Item Candidate Device KRONUS 21-OHAb ELISA Kit Predicate Device KRONUS 21-OHAb RIA Assay Kit Intended Use The KRONUS Steroid 21-
Hydroxylase Autoantibody (21-
OHAb) ELISA Kit is for the qualitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum. The Steroid 21-Hydroxylase Autoantibody (21-
OHAb) ELISA Kit is useful as an aid in the diagnosis of autoimmune adrenal disease, whether expressed as autoimmune Addison's disease (isolated) or Addison's disease as part of the more complex autoimmune polyglandular syndrome (APS), type I or II. The assay result is to be used in conjunction with other clinical and laboratory findings and is not a substitute for functional testing required to diagnose adrenal insufficiency. Same Analyte Steroid 21-Hydroxylase autoantibodies Same Sample Matrix Serum Same Incubation time Overnight (16–20 hours) Same Differences Item Candidate Device KRONUS 21-OHAb ELISA Kit Predicate Device KRONUS 21-OHAb RIA Assay Kit Methodology Autoantibodies to 21-OH bind to 21-
OH -biotin, are detected by a colorimetric reaction with streptavidin-peroxidase and Autoantibodies to 21-OH react with I125-labeled 21-OH tracer, are precipitated with Protein A, and read off a 4
Differences
Item
Candidate Device
KRONUS 21-OHAb ELISA Kit
Predicate Device KRONUS 21-OHAb RIA Assay Kit
tetramethyl benzidine and read off a reference preparation calibration curve Method/Principle Enzyme-linked immunosorbent assay (ELISA) Radioimmunoassay (RIA) Assay format Qualitative Semi-quantitative Detection Equipment Plate Reader Gamma counter Cut-off Positive:� ≥�45 Negative: < 45 Positive: > 1 U/mL Negative:�≤�1�U/mL K. Standard/Guidance Document Referenced (if applicable): · CLSI guideline EP12-A2, User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline–Second Edition · CLSI guideline EP07-A2, Interference Testing in Clinical Chemistry - Second Edition · CLSI guideline C28-A3c, Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline- Third Edition L. Test Principle: The KRONUS Steroid 21-Hydroxylase Autoantibody (21-OHAb) ELISA Kit depends on the divalent properties of the Steroid 21-Hydroxylase autoantibodies (21-OHAb) to form a bridge between 21-OH coated on ELISA plate wells and liquid phase 21-OH-
biotin. The level of bound 21-OHAb is then quantitated by the sequential addition of streptavidin peroxidase (SA-POD) and tetramethylbenzidine (TMB; a chromogenic substrate) to produce a colorogenic reaction. Stop solution is added to halt the reaction and absorbance is read using an ELISA plate reader with absorbance at 450 nm. The absorbance of each specimen is compared to the reference preparation, allowing for an index value to be calculated from the mean value of duplicate wells as follows: Index = test sample absorbance at 450 nm x 100 reference preparation absorbance at 450 nm Results are reported as “Negative”, “Positive”, or “Indeterminate”. A specimen with an index value equal to or greater than the specified cut-off (i.e. ≥45) is considered positive for antibodies against 21-OH while an index value below this cut-off (i.e. <45) is considered negative for 21-OH antibodies. 5
Index values are calculated from the mean of duplicates. Results can be considered valid determinations if sample replicates yield the same clinical interpretation (i.e. both replicates�have�index� values�that�are�<45�or�≥45)�and�coefficient�of�variation� does�not�
exceed 20% for determinations calculated from duplicates with at least one index value in the range
Classification: |
idK180607_s0_e2000 | K180607.txt | panel | Immunology� (82)� | (k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K180607 B. Purpose for Submission: New device C. Measurand: Steroid 21-Hydroxylase Antibody (21-OHAb) D. Type of Test: Manual�enzyme-linked� immunosorbent� assay,�qualitative E. Applicant: KRONUS�Market�Development� Associates,�INC.�
F. Proprietary and Established Names: KRONUS�Steroid� 21-Hydroxylase� Autoantibody� (21-OHAb)�ELISA�Kit G. Regulatory Information: 1.� Regulation� section:�
21�CFR�§�866.5660,� Multiple� autoantibody� immunological� test�system�
2.� Classification:�
Class�II�
3. Product�code:�
PCG,�21-Hydroxylase� Antibody� (21-OHAb)�antibody� assay�
4.� Panel:�
Immunology� (82)�
2
H. Intended Use: 1. Intended use: The KRONUS Steroid 21-Hydroxylase Autoantibody (21-OHAb) ELISA Kit is for the qualitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum. The Steroid 21-Hydroxylase Autoantibody (21-OHAb) ELISA Kit is useful as an aid in the diagnosis of autoimmune adrenal disease, whether expressed as autoimmune Addison's disease (isolated) or Addison's disease as part of the more complex autoimmune polyglandular syndrome (APS), type I or II. The assay result is to be used in conjunction with other clinical and laboratory findings and is not a substitute for functional testing required to diagnose adrenal insufficiency. 2. Indication for use: Same as intended use 3. Special conditions for use statement: For prescription use only. 4. Special instrument requirements: Microtiter plate reader capable of measuring a 96 well plate at 405 nm I. Device Description: The�KRONUS�Steroid� 21-Hydroxylase�Autoantibody� (21-OHAb)�ELISA�Kit�consists�
of�the�following� components:�
1. Recombinant� human�21-OHAb-coated�ELISA�strip�wells,� 96�wells�in�total�and�
supplied� as�12�strips�of�eight� wells�in�a�frame�and�sealed�in�a�foil� pouch�with�
desiccant�
2. Reference�Preparation,1�x�0.7�mL�(ready�to�use)�
3. Kit�Negative�Control,1� x�0.7�mL�(ready�to�use)�
4. Kit�Positive�Control� 1�and�2�(see�label�for�ranges),�2�x�0.7�mL�(ready�to�use)�
5. 21-OH�Reaction�Enhancer�(colored�red),�1�x�6�mL�(ready�to�use)�
6. 21-OH�Biotin� (lyophilized),� 3�x�5.5�mL�(reconstitute�immediately� prior�to�use)�
7. 21-OH�Biotin� Reconstitution� Buffer,�2�x�10�mL�(ready�to�use)�
8. Streptavidin� Peroxidase�(SA-POD),�1�x�0.7�mL�(dilute� SA-POD�1:20� before�use)�
9. Streptavidin-Peroxidase� Diluent,� 1�x�15�mL�(ready�to�use)�
10. Tetramethylbenzidine� Peroxidase�Substrate�(TMB),�1�x�15�mL�(ready�to�use)�
11. Stop�solution� (contains�0.25M�H2SO4),�1�x�12�mL�(ready-to-use)�
12. Concentrated�Wash�Solution� 1�x�125�mL�(dilute�1:10� with�deionized� water�before�
use)�
3
J. Substantial Equivalence Information: 1. Predicate device name and 510(k) number: KRONUS 21-OHAb RIA Assay Kit (K121046) 2. Comparison with predicate(s): Similarities Item Candidate Device KRONUS 21-OHAb ELISA Kit Predicate Device KRONUS 21-OHAb RIA Assay Kit Intended Use The KRONUS Steroid 21-
Hydroxylase Autoantibody (21-
OHAb) ELISA Kit is for the qualitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum. The Steroid 21-Hydroxylase Autoantibody (21-
OHAb) ELISA Kit is useful as an aid in the diagnosis of autoimmune adrenal disease, whether expressed as autoimmune Addison's disease (isolated) or Addison's disease as part of the more complex autoimmune polyglandular syndrome (APS), type I or II. The assay result is to be used in conjunction with other clinical and laboratory findings and is not a substitute for functional testing required to diagnose adrenal insufficiency. Same Analyte Steroid 21-Hydroxylase autoantibodies Same Sample Matrix Serum Same Incubation time Overnight (16–20 hours) Same Differences Item Candidate Device KRONUS 21-OHAb ELISA Kit Predicate Device KRONUS 21-OHAb RIA Assay Kit Methodology Autoantibodies to 21-OH bind to 21-
OH -biotin, are detected by a colorimetric reaction with streptavidin-peroxidase and Autoantibodies to 21-OH react with I125-labeled 21-OH tracer, are precipitated with Protein A, and read off a 4
Differences
Item
Candidate Device
KRONUS 21-OHAb ELISA Kit
Predicate Device KRONUS 21-OHAb RIA Assay Kit
tetramethyl benzidine and read off a reference preparation calibration curve Method/Principle Enzyme-linked immunosorbent assay (ELISA) Radioimmunoassay (RIA) Assay format Qualitative Semi-quantitative Detection Equipment Plate Reader Gamma counter Cut-off Positive:� ≥�45 Negative: < 45 Positive: > 1 U/mL Negative:�≤�1�U/mL K. Standard/Guidance Document Referenced (if applicable): · CLSI guideline EP12-A2, User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline–Second Edition · CLSI guideline EP07-A2, Interference Testing in Clinical Chemistry - Second Edition · CLSI guideline C28-A3c, Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline- Third Edition L. Test Principle: The KRONUS Steroid 21-Hydroxylase Autoantibody (21-OHAb) ELISA Kit depends on the divalent properties of the Steroid 21-Hydroxylase autoantibodies (21-OHAb) to form a bridge between 21-OH coated on ELISA plate wells and liquid phase 21-OH-
biotin. The level of bound 21-OHAb is then quantitated by the sequential addition of streptavidin peroxidase (SA-POD) and tetramethylbenzidine (TMB; a chromogenic substrate) to produce a colorogenic reaction. Stop solution is added to halt the reaction and absorbance is read using an ELISA plate reader with absorbance at 450 nm. The absorbance of each specimen is compared to the reference preparation, allowing for an index value to be calculated from the mean value of duplicate wells as follows: Index = test sample absorbance at 450 nm x 100 reference preparation absorbance at 450 nm Results are reported as “Negative”, “Positive”, or “Indeterminate”. A specimen with an index value equal to or greater than the specified cut-off (i.e. ≥45) is considered positive for antibodies against 21-OH while an index value below this cut-off (i.e. <45) is considered negative for 21-OH antibodies. 5
Index values are calculated from the mean of duplicates. Results can be considered valid determinations if sample replicates yield the same clinical interpretation (i.e. both replicates�have�index� values�that�are�<45�or�≥45)�and�coefficient�of�variation� does�not�
exceed 20% for determinations calculated from duplicates with at least one index value in the range
Panel: |
idK180607_s0_e2000 | K180607.txt | intended use | The KRONUS Steroid 21-Hydroxylase Autoantibody (21-OHAb) ELISA Kit is for the qualitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum. The Steroid 21-Hydroxylase Autoantibody (21-OHAb) ELISA Kit is useful as an aid in the diagnosis of autoimmune adrenal disease, whether expressed as autoimmune Addison's disease (isolated) or Addison's disease as part of the more complex autoimmune polyglandular syndrome (APS), type I or II. The assay result is to be used in conjunction with other clinical and laboratory findings and is not a substitute for functional testing required to diagnose adrenal insufficiency. | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K180607 B. Purpose for Submission: New device C. Measurand: Steroid 21-Hydroxylase Antibody (21-OHAb) D. Type of Test: Manual�enzyme-linked� immunosorbent� assay,�qualitative E. Applicant: KRONUS�Market�Development� Associates,�INC.�
F. Proprietary and Established Names: KRONUS�Steroid� 21-Hydroxylase� Autoantibody� (21-OHAb)�ELISA�Kit G. Regulatory Information: 1.� Regulation� section:�
21�CFR�§�866.5660,� Multiple� autoantibody� immunological� test�system�
2.� Classification:�
Class�II�
3. Product�code:�
PCG,�21-Hydroxylase� Antibody� (21-OHAb)�antibody� assay�
4.� Panel:�
Immunology� (82)�
2
H. Intended Use: 1. Intended use: The KRONUS Steroid 21-Hydroxylase Autoantibody (21-OHAb) ELISA Kit is for the qualitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum. The Steroid 21-Hydroxylase Autoantibody (21-OHAb) ELISA Kit is useful as an aid in the diagnosis of autoimmune adrenal disease, whether expressed as autoimmune Addison's disease (isolated) or Addison's disease as part of the more complex autoimmune polyglandular syndrome (APS), type I or II. The assay result is to be used in conjunction with other clinical and laboratory findings and is not a substitute for functional testing required to diagnose adrenal insufficiency. 2. Indication for use: Same as intended use 3. Special conditions for use statement: For prescription use only. 4. Special instrument requirements: Microtiter plate reader capable of measuring a 96 well plate at 405 nm I. Device Description: The�KRONUS�Steroid� 21-Hydroxylase�Autoantibody� (21-OHAb)�ELISA�Kit�consists�
of�the�following� components:�
1. Recombinant� human�21-OHAb-coated�ELISA�strip�wells,� 96�wells�in�total�and�
supplied� as�12�strips�of�eight� wells�in�a�frame�and�sealed�in�a�foil� pouch�with�
desiccant�
2. Reference�Preparation,1�x�0.7�mL�(ready�to�use)�
3. Kit�Negative�Control,1� x�0.7�mL�(ready�to�use)�
4. Kit�Positive�Control� 1�and�2�(see�label�for�ranges),�2�x�0.7�mL�(ready�to�use)�
5. 21-OH�Reaction�Enhancer�(colored�red),�1�x�6�mL�(ready�to�use)�
6. 21-OH�Biotin� (lyophilized),� 3�x�5.5�mL�(reconstitute�immediately� prior�to�use)�
7. 21-OH�Biotin� Reconstitution� Buffer,�2�x�10�mL�(ready�to�use)�
8. Streptavidin� Peroxidase�(SA-POD),�1�x�0.7�mL�(dilute� SA-POD�1:20� before�use)�
9. Streptavidin-Peroxidase� Diluent,� 1�x�15�mL�(ready�to�use)�
10. Tetramethylbenzidine� Peroxidase�Substrate�(TMB),�1�x�15�mL�(ready�to�use)�
11. Stop�solution� (contains�0.25M�H2SO4),�1�x�12�mL�(ready-to-use)�
12. Concentrated�Wash�Solution� 1�x�125�mL�(dilute�1:10� with�deionized� water�before�
use)�
3
J. Substantial Equivalence Information: 1. Predicate device name and 510(k) number: KRONUS 21-OHAb RIA Assay Kit (K121046) 2. Comparison with predicate(s): Similarities Item Candidate Device KRONUS 21-OHAb ELISA Kit Predicate Device KRONUS 21-OHAb RIA Assay Kit Intended Use The KRONUS Steroid 21-
Hydroxylase Autoantibody (21-
OHAb) ELISA Kit is for the qualitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum. The Steroid 21-Hydroxylase Autoantibody (21-
OHAb) ELISA Kit is useful as an aid in the diagnosis of autoimmune adrenal disease, whether expressed as autoimmune Addison's disease (isolated) or Addison's disease as part of the more complex autoimmune polyglandular syndrome (APS), type I or II. The assay result is to be used in conjunction with other clinical and laboratory findings and is not a substitute for functional testing required to diagnose adrenal insufficiency. Same Analyte Steroid 21-Hydroxylase autoantibodies Same Sample Matrix Serum Same Incubation time Overnight (16–20 hours) Same Differences Item Candidate Device KRONUS 21-OHAb ELISA Kit Predicate Device KRONUS 21-OHAb RIA Assay Kit Methodology Autoantibodies to 21-OH bind to 21-
OH -biotin, are detected by a colorimetric reaction with streptavidin-peroxidase and Autoantibodies to 21-OH react with I125-labeled 21-OH tracer, are precipitated with Protein A, and read off a 4
Differences
Item
Candidate Device
KRONUS 21-OHAb ELISA Kit
Predicate Device KRONUS 21-OHAb RIA Assay Kit
tetramethyl benzidine and read off a reference preparation calibration curve Method/Principle Enzyme-linked immunosorbent assay (ELISA) Radioimmunoassay (RIA) Assay format Qualitative Semi-quantitative Detection Equipment Plate Reader Gamma counter Cut-off Positive:� ≥�45 Negative: < 45 Positive: > 1 U/mL Negative:�≤�1�U/mL K. Standard/Guidance Document Referenced (if applicable): · CLSI guideline EP12-A2, User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline–Second Edition · CLSI guideline EP07-A2, Interference Testing in Clinical Chemistry - Second Edition · CLSI guideline C28-A3c, Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline- Third Edition L. Test Principle: The KRONUS Steroid 21-Hydroxylase Autoantibody (21-OHAb) ELISA Kit depends on the divalent properties of the Steroid 21-Hydroxylase autoantibodies (21-OHAb) to form a bridge between 21-OH coated on ELISA plate wells and liquid phase 21-OH-
biotin. The level of bound 21-OHAb is then quantitated by the sequential addition of streptavidin peroxidase (SA-POD) and tetramethylbenzidine (TMB; a chromogenic substrate) to produce a colorogenic reaction. Stop solution is added to halt the reaction and absorbance is read using an ELISA plate reader with absorbance at 450 nm. The absorbance of each specimen is compared to the reference preparation, allowing for an index value to be calculated from the mean value of duplicate wells as follows: Index = test sample absorbance at 450 nm x 100 reference preparation absorbance at 450 nm Results are reported as “Negative”, “Positive”, or “Indeterminate”. A specimen with an index value equal to or greater than the specified cut-off (i.e. ≥45) is considered positive for antibodies against 21-OH while an index value below this cut-off (i.e. <45) is considered negative for 21-OH antibodies. 5
Index values are calculated from the mean of duplicates. Results can be considered valid determinations if sample replicates yield the same clinical interpretation (i.e. both replicates�have�index� values�that�are�<45�or�≥45)�and�coefficient�of�variation� does�not�
exceed 20% for determinations calculated from duplicates with at least one index value in the range
Intended use: |
idK180607_s0_e2000 | K180607.txt | predicate device name | KRONUS 21-OHAb RIA Assay Kit | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K180607 B. Purpose for Submission: New device C. Measurand: Steroid 21-Hydroxylase Antibody (21-OHAb) D. Type of Test: Manual�enzyme-linked� immunosorbent� assay,�qualitative E. Applicant: KRONUS�Market�Development� Associates,�INC.�
F. Proprietary and Established Names: KRONUS�Steroid� 21-Hydroxylase� Autoantibody� (21-OHAb)�ELISA�Kit G. Regulatory Information: 1.� Regulation� section:�
21�CFR�§�866.5660,� Multiple� autoantibody� immunological� test�system�
2.� Classification:�
Class�II�
3. Product�code:�
PCG,�21-Hydroxylase� Antibody� (21-OHAb)�antibody� assay�
4.� Panel:�
Immunology� (82)�
2
H. Intended Use: 1. Intended use: The KRONUS Steroid 21-Hydroxylase Autoantibody (21-OHAb) ELISA Kit is for the qualitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum. The Steroid 21-Hydroxylase Autoantibody (21-OHAb) ELISA Kit is useful as an aid in the diagnosis of autoimmune adrenal disease, whether expressed as autoimmune Addison's disease (isolated) or Addison's disease as part of the more complex autoimmune polyglandular syndrome (APS), type I or II. The assay result is to be used in conjunction with other clinical and laboratory findings and is not a substitute for functional testing required to diagnose adrenal insufficiency. 2. Indication for use: Same as intended use 3. Special conditions for use statement: For prescription use only. 4. Special instrument requirements: Microtiter plate reader capable of measuring a 96 well plate at 405 nm I. Device Description: The�KRONUS�Steroid� 21-Hydroxylase�Autoantibody� (21-OHAb)�ELISA�Kit�consists�
of�the�following� components:�
1. Recombinant� human�21-OHAb-coated�ELISA�strip�wells,� 96�wells�in�total�and�
supplied� as�12�strips�of�eight� wells�in�a�frame�and�sealed�in�a�foil� pouch�with�
desiccant�
2. Reference�Preparation,1�x�0.7�mL�(ready�to�use)�
3. Kit�Negative�Control,1� x�0.7�mL�(ready�to�use)�
4. Kit�Positive�Control� 1�and�2�(see�label�for�ranges),�2�x�0.7�mL�(ready�to�use)�
5. 21-OH�Reaction�Enhancer�(colored�red),�1�x�6�mL�(ready�to�use)�
6. 21-OH�Biotin� (lyophilized),� 3�x�5.5�mL�(reconstitute�immediately� prior�to�use)�
7. 21-OH�Biotin� Reconstitution� Buffer,�2�x�10�mL�(ready�to�use)�
8. Streptavidin� Peroxidase�(SA-POD),�1�x�0.7�mL�(dilute� SA-POD�1:20� before�use)�
9. Streptavidin-Peroxidase� Diluent,� 1�x�15�mL�(ready�to�use)�
10. Tetramethylbenzidine� Peroxidase�Substrate�(TMB),�1�x�15�mL�(ready�to�use)�
11. Stop�solution� (contains�0.25M�H2SO4),�1�x�12�mL�(ready-to-use)�
12. Concentrated�Wash�Solution� 1�x�125�mL�(dilute�1:10� with�deionized� water�before�
use)�
3
J. Substantial Equivalence Information: 1. Predicate device name and 510(k) number: KRONUS 21-OHAb RIA Assay Kit (K121046) 2. Comparison with predicate(s): Similarities Item Candidate Device KRONUS 21-OHAb ELISA Kit Predicate Device KRONUS 21-OHAb RIA Assay Kit Intended Use The KRONUS Steroid 21-
Hydroxylase Autoantibody (21-
OHAb) ELISA Kit is for the qualitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum. The Steroid 21-Hydroxylase Autoantibody (21-
OHAb) ELISA Kit is useful as an aid in the diagnosis of autoimmune adrenal disease, whether expressed as autoimmune Addison's disease (isolated) or Addison's disease as part of the more complex autoimmune polyglandular syndrome (APS), type I or II. The assay result is to be used in conjunction with other clinical and laboratory findings and is not a substitute for functional testing required to diagnose adrenal insufficiency. Same Analyte Steroid 21-Hydroxylase autoantibodies Same Sample Matrix Serum Same Incubation time Overnight (16–20 hours) Same Differences Item Candidate Device KRONUS 21-OHAb ELISA Kit Predicate Device KRONUS 21-OHAb RIA Assay Kit Methodology Autoantibodies to 21-OH bind to 21-
OH -biotin, are detected by a colorimetric reaction with streptavidin-peroxidase and Autoantibodies to 21-OH react with I125-labeled 21-OH tracer, are precipitated with Protein A, and read off a 4
Differences
Item
Candidate Device
KRONUS 21-OHAb ELISA Kit
Predicate Device KRONUS 21-OHAb RIA Assay Kit
tetramethyl benzidine and read off a reference preparation calibration curve Method/Principle Enzyme-linked immunosorbent assay (ELISA) Radioimmunoassay (RIA) Assay format Qualitative Semi-quantitative Detection Equipment Plate Reader Gamma counter Cut-off Positive:� ≥�45 Negative: < 45 Positive: > 1 U/mL Negative:�≤�1�U/mL K. Standard/Guidance Document Referenced (if applicable): · CLSI guideline EP12-A2, User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline–Second Edition · CLSI guideline EP07-A2, Interference Testing in Clinical Chemistry - Second Edition · CLSI guideline C28-A3c, Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline- Third Edition L. Test Principle: The KRONUS Steroid 21-Hydroxylase Autoantibody (21-OHAb) ELISA Kit depends on the divalent properties of the Steroid 21-Hydroxylase autoantibodies (21-OHAb) to form a bridge between 21-OH coated on ELISA plate wells and liquid phase 21-OH-
biotin. The level of bound 21-OHAb is then quantitated by the sequential addition of streptavidin peroxidase (SA-POD) and tetramethylbenzidine (TMB; a chromogenic substrate) to produce a colorogenic reaction. Stop solution is added to halt the reaction and absorbance is read using an ELISA plate reader with absorbance at 450 nm. The absorbance of each specimen is compared to the reference preparation, allowing for an index value to be calculated from the mean value of duplicate wells as follows: Index = test sample absorbance at 450 nm x 100 reference preparation absorbance at 450 nm Results are reported as “Negative”, “Positive”, or “Indeterminate”. A specimen with an index value equal to or greater than the specified cut-off (i.e. ≥45) is considered positive for antibodies against 21-OH while an index value below this cut-off (i.e. <45) is considered negative for 21-OH antibodies. 5
Index values are calculated from the mean of duplicates. Results can be considered valid determinations if sample replicates yield the same clinical interpretation (i.e. both replicates�have�index� values�that�are�<45�or�≥45)�and�coefficient�of�variation� does�not�
exceed 20% for determinations calculated from duplicates with at least one index value in the range
Predicate device name: |
idK180607_s0_e2000 | K180607.txt | applicant | KRONUS�Market�Development� Associates,�INC.� | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K180607 B. Purpose for Submission: New device C. Measurand: Steroid 21-Hydroxylase Antibody (21-OHAb) D. Type of Test: Manual�enzyme-linked� immunosorbent� assay,�qualitative E. Applicant: KRONUS�Market�Development� Associates,�INC.�
F. Proprietary and Established Names: KRONUS�Steroid� 21-Hydroxylase� Autoantibody� (21-OHAb)�ELISA�Kit G. Regulatory Information: 1.� Regulation� section:�
21�CFR�§�866.5660,� Multiple� autoantibody� immunological� test�system�
2.� Classification:�
Class�II�
3. Product�code:�
PCG,�21-Hydroxylase� Antibody� (21-OHAb)�antibody� assay�
4.� Panel:�
Immunology� (82)�
2
H. Intended Use: 1. Intended use: The KRONUS Steroid 21-Hydroxylase Autoantibody (21-OHAb) ELISA Kit is for the qualitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum. The Steroid 21-Hydroxylase Autoantibody (21-OHAb) ELISA Kit is useful as an aid in the diagnosis of autoimmune adrenal disease, whether expressed as autoimmune Addison's disease (isolated) or Addison's disease as part of the more complex autoimmune polyglandular syndrome (APS), type I or II. The assay result is to be used in conjunction with other clinical and laboratory findings and is not a substitute for functional testing required to diagnose adrenal insufficiency. 2. Indication for use: Same as intended use 3. Special conditions for use statement: For prescription use only. 4. Special instrument requirements: Microtiter plate reader capable of measuring a 96 well plate at 405 nm I. Device Description: The�KRONUS�Steroid� 21-Hydroxylase�Autoantibody� (21-OHAb)�ELISA�Kit�consists�
of�the�following� components:�
1. Recombinant� human�21-OHAb-coated�ELISA�strip�wells,� 96�wells�in�total�and�
supplied� as�12�strips�of�eight� wells�in�a�frame�and�sealed�in�a�foil� pouch�with�
desiccant�
2. Reference�Preparation,1�x�0.7�mL�(ready�to�use)�
3. Kit�Negative�Control,1� x�0.7�mL�(ready�to�use)�
4. Kit�Positive�Control� 1�and�2�(see�label�for�ranges),�2�x�0.7�mL�(ready�to�use)�
5. 21-OH�Reaction�Enhancer�(colored�red),�1�x�6�mL�(ready�to�use)�
6. 21-OH�Biotin� (lyophilized),� 3�x�5.5�mL�(reconstitute�immediately� prior�to�use)�
7. 21-OH�Biotin� Reconstitution� Buffer,�2�x�10�mL�(ready�to�use)�
8. Streptavidin� Peroxidase�(SA-POD),�1�x�0.7�mL�(dilute� SA-POD�1:20� before�use)�
9. Streptavidin-Peroxidase� Diluent,� 1�x�15�mL�(ready�to�use)�
10. Tetramethylbenzidine� Peroxidase�Substrate�(TMB),�1�x�15�mL�(ready�to�use)�
11. Stop�solution� (contains�0.25M�H2SO4),�1�x�12�mL�(ready-to-use)�
12. Concentrated�Wash�Solution� 1�x�125�mL�(dilute�1:10� with�deionized� water�before�
use)�
3
J. Substantial Equivalence Information: 1. Predicate device name and 510(k) number: KRONUS 21-OHAb RIA Assay Kit (K121046) 2. Comparison with predicate(s): Similarities Item Candidate Device KRONUS 21-OHAb ELISA Kit Predicate Device KRONUS 21-OHAb RIA Assay Kit Intended Use The KRONUS Steroid 21-
Hydroxylase Autoantibody (21-
OHAb) ELISA Kit is for the qualitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum. The Steroid 21-Hydroxylase Autoantibody (21-
OHAb) ELISA Kit is useful as an aid in the diagnosis of autoimmune adrenal disease, whether expressed as autoimmune Addison's disease (isolated) or Addison's disease as part of the more complex autoimmune polyglandular syndrome (APS), type I or II. The assay result is to be used in conjunction with other clinical and laboratory findings and is not a substitute for functional testing required to diagnose adrenal insufficiency. Same Analyte Steroid 21-Hydroxylase autoantibodies Same Sample Matrix Serum Same Incubation time Overnight (16–20 hours) Same Differences Item Candidate Device KRONUS 21-OHAb ELISA Kit Predicate Device KRONUS 21-OHAb RIA Assay Kit Methodology Autoantibodies to 21-OH bind to 21-
OH -biotin, are detected by a colorimetric reaction with streptavidin-peroxidase and Autoantibodies to 21-OH react with I125-labeled 21-OH tracer, are precipitated with Protein A, and read off a 4
Differences
Item
Candidate Device
KRONUS 21-OHAb ELISA Kit
Predicate Device KRONUS 21-OHAb RIA Assay Kit
tetramethyl benzidine and read off a reference preparation calibration curve Method/Principle Enzyme-linked immunosorbent assay (ELISA) Radioimmunoassay (RIA) Assay format Qualitative Semi-quantitative Detection Equipment Plate Reader Gamma counter Cut-off Positive:� ≥�45 Negative: < 45 Positive: > 1 U/mL Negative:�≤�1�U/mL K. Standard/Guidance Document Referenced (if applicable): · CLSI guideline EP12-A2, User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline–Second Edition · CLSI guideline EP07-A2, Interference Testing in Clinical Chemistry - Second Edition · CLSI guideline C28-A3c, Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline- Third Edition L. Test Principle: The KRONUS Steroid 21-Hydroxylase Autoantibody (21-OHAb) ELISA Kit depends on the divalent properties of the Steroid 21-Hydroxylase autoantibodies (21-OHAb) to form a bridge between 21-OH coated on ELISA plate wells and liquid phase 21-OH-
biotin. The level of bound 21-OHAb is then quantitated by the sequential addition of streptavidin peroxidase (SA-POD) and tetramethylbenzidine (TMB; a chromogenic substrate) to produce a colorogenic reaction. Stop solution is added to halt the reaction and absorbance is read using an ELISA plate reader with absorbance at 450 nm. The absorbance of each specimen is compared to the reference preparation, allowing for an index value to be calculated from the mean value of duplicate wells as follows: Index = test sample absorbance at 450 nm x 100 reference preparation absorbance at 450 nm Results are reported as “Negative”, “Positive”, or “Indeterminate”. A specimen with an index value equal to or greater than the specified cut-off (i.e. ≥45) is considered positive for antibodies against 21-OH while an index value below this cut-off (i.e. <45) is considered negative for 21-OH antibodies. 5
Index values are calculated from the mean of duplicates. Results can be considered valid determinations if sample replicates yield the same clinical interpretation (i.e. both replicates�have�index� values�that�are�<45�or�≥45)�and�coefficient�of�variation� does�not�
exceed 20% for determinations calculated from duplicates with at least one index value in the range
Applicant: |
idK180607_s0_e2000 | K180607.txt | proprietary and established names | KRONUS�Steroid� 21-Hydroxylase� Autoantibody� (21-OHAb)�ELISA�Kit | ANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K180607 B. Purpose for Submission: New device C. Measurand: Steroid 21-Hydroxylase Antibody (21-OHAb) D. Type of Test: Manual�enzyme-linked� immunosorbent� assay,�qualitative E. Applicant: KRONUS�Market�Development� Associates,�INC.�
F. Proprietary and Established Names: KRONUS�Steroid� 21-Hydroxylase� Autoantibody� (21-OHAb)�ELISA�Kit G. Regulatory Information: 1.� Regulation� section:�
21�CFR�§�866.5660,� Multiple� autoantibody� immunological� test�system�
2.� Classification:�
Class�II�
3. Product�code:�
PCG,�21-Hydroxylase� Antibody� (21-OHAb)�antibody� assay�
4.� Panel:�
Immunology� (82)�
2
H. Intended Use: 1. Intended use: The KRONUS Steroid 21-Hydroxylase Autoantibody (21-OHAb) ELISA Kit is for the qualitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum. The Steroid 21-Hydroxylase Autoantibody (21-OHAb) ELISA Kit is useful as an aid in the diagnosis of autoimmune adrenal disease, whether expressed as autoimmune Addison's disease (isolated) or Addison's disease as part of the more complex autoimmune polyglandular syndrome (APS), type I or II. The assay result is to be used in conjunction with other clinical and laboratory findings and is not a substitute for functional testing required to diagnose adrenal insufficiency. 2. Indication for use: Same as intended use 3. Special conditions for use statement: For prescription use only. 4. Special instrument requirements: Microtiter plate reader capable of measuring a 96 well plate at 405 nm I. Device Description: The�KRONUS�Steroid� 21-Hydroxylase�Autoantibody� (21-OHAb)�ELISA�Kit�consists�
of�the�following� components:�
1. Recombinant� human�21-OHAb-coated�ELISA�strip�wells,� 96�wells�in�total�and�
supplied� as�12�strips�of�eight� wells�in�a�frame�and�sealed�in�a�foil� pouch�with�
desiccant�
2. Reference�Preparation,1�x�0.7�mL�(ready�to�use)�
3. Kit�Negative�Control,1� x�0.7�mL�(ready�to�use)�
4. Kit�Positive�Control� 1�and�2�(see�label�for�ranges),�2�x�0.7�mL�(ready�to�use)�
5. 21-OH�Reaction�Enhancer�(colored�red),�1�x�6�mL�(ready�to�use)�
6. 21-OH�Biotin� (lyophilized),� 3�x�5.5�mL�(reconstitute�immediately� prior�to�use)�
7. 21-OH�Biotin� Reconstitution� Buffer,�2�x�10�mL�(ready�to�use)�
8. Streptavidin� Peroxidase�(SA-POD),�1�x�0.7�mL�(dilute� SA-POD�1:20� before�use)�
9. Streptavidin-Peroxidase� Diluent,� 1�x�15�mL�(ready�to�use)�
10. Tetramethylbenzidine� Peroxidase�Substrate�(TMB),�1�x�15�mL�(ready�to�use)�
11. Stop�solution� (contains�0.25M�H2SO4),�1�x�12�mL�(ready-to-use)�
12. Concentrated�Wash�Solution� 1�x�125�mL�(dilute�1:10� with�deionized� water�before�
use)�
3
J. Substantial Equivalence Information: 1. Predicate device name and 510(k) number: KRONUS 21-OHAb RIA Assay Kit (K121046) 2. Comparison with predicate(s): Similarities Item Candidate Device KRONUS 21-OHAb ELISA Kit Predicate Device KRONUS 21-OHAb RIA Assay Kit Intended Use The KRONUS Steroid 21-
Hydroxylase Autoantibody (21-
OHAb) ELISA Kit is for the qualitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum. The Steroid 21-Hydroxylase Autoantibody (21-
OHAb) ELISA Kit is useful as an aid in the diagnosis of autoimmune adrenal disease, whether expressed as autoimmune Addison's disease (isolated) or Addison's disease as part of the more complex autoimmune polyglandular syndrome (APS), type I or II. The assay result is to be used in conjunction with other clinical and laboratory findings and is not a substitute for functional testing required to diagnose adrenal insufficiency. Same Analyte Steroid 21-Hydroxylase autoantibodies Same Sample Matrix Serum Same Incubation time Overnight (16–20 hours) Same Differences Item Candidate Device KRONUS 21-OHAb ELISA Kit Predicate Device KRONUS 21-OHAb RIA Assay Kit Methodology Autoantibodies to 21-OH bind to 21-
OH -biotin, are detected by a colorimetric reaction with streptavidin-peroxidase and Autoantibodies to 21-OH react with I125-labeled 21-OH tracer, are precipitated with Protein A, and read off a 4
Differences
Item
Candidate Device
KRONUS 21-OHAb ELISA Kit
Predicate Device KRONUS 21-OHAb RIA Assay Kit
tetramethyl benzidine and read off a reference preparation calibration curve Method/Principle Enzyme-linked immunosorbent assay (ELISA) Radioimmunoassay (RIA) Assay format Qualitative Semi-quantitative Detection Equipment Plate Reader Gamma counter Cut-off Positive:� ≥�45 Negative: < 45 Positive: > 1 U/mL Negative:�≤�1�U/mL K. Standard/Guidance Document Referenced (if applicable): · CLSI guideline EP12-A2, User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline–Second Edition · CLSI guideline EP07-A2, Interference Testing in Clinical Chemistry - Second Edition · CLSI guideline C28-A3c, Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline- Third Edition L. Test Principle: The KRONUS Steroid 21-Hydroxylase Autoantibody (21-OHAb) ELISA Kit depends on the divalent properties of the Steroid 21-Hydroxylase autoantibodies (21-OHAb) to form a bridge between 21-OH coated on ELISA plate wells and liquid phase 21-OH-
biotin. The level of bound 21-OHAb is then quantitated by the sequential addition of streptavidin peroxidase (SA-POD) and tetramethylbenzidine (TMB; a chromogenic substrate) to produce a colorogenic reaction. Stop solution is added to halt the reaction and absorbance is read using an ELISA plate reader with absorbance at 450 nm. The absorbance of each specimen is compared to the reference preparation, allowing for an index value to be calculated from the mean value of duplicate wells as follows: Index = test sample absorbance at 450 nm x 100 reference preparation absorbance at 450 nm Results are reported as “Negative”, “Positive”, or “Indeterminate”. A specimen with an index value equal to or greater than the specified cut-off (i.e. ≥45) is considered positive for antibodies against 21-OH while an index value below this cut-off (i.e. <45) is considered negative for 21-OH antibodies. 5
Index values are calculated from the mean of duplicates. Results can be considered valid determinations if sample replicates yield the same clinical interpretation (i.e. both replicates�have�index� values�that�are�<45�or�≥45)�and�coefficient�of�variation� does�not�
exceed 20% for determinations calculated from duplicates with at least one index value in the range
Proprietary and established names: |
idK180607_s8000_e10000 | K180607.txt | proposed labeling | The�labeling� is�sufficient� and�it�satisfies�the�requirements�of�21�CFR�Part�809.10.� | � PAS�Type�II�
61�
58�(95.1%)�
Total�
94/108� (87.0%)�
NonTarget Disease Other AutoImmune Conditions / Noninfectious Disease�
Rheumatoid�Arthritis�
16�
0�(0.0%)�
Type�1�Diabetes�
71�
2�(2.8%)�
Neuromyelitis� Optica�Spectrum�Disorder�
8�
0�(0.0%)�
14
# Evaluated # Positive Non-Target Disease Other Auto-Immune Conditions / Non-infectious Diseases Hashimoto's Thyroiditis 30 0 (0.0%) Graves' Disease 58 0 (0.0%) Systemic Lupus Erythematosus 9 0 (0.0%) Amyloidosis 2 0 (0.0%) Sarcoidosis 14 0 (0.0%) Vitiligo 4 0 (0.0%) Sjogren’s Syndrome 17 0 (0.0%) Premature Ovarian Failure 3 0 (0.0%) Hypoparathyroidism 8 0 (0.0%) Pernicious Anemia 10 0 (0.0%) Infectious Diseases Coccidiodomycosis 1 0 (0.0%) Candidiasis 10 0 (0.0%) Histoplasmosis 10 0 (0.0%) Mycobacterium Tuberculosis 2 0 (0.0%) Human Immunodeficiency Virus 10 0 (0.0%) Cytomeglovirus 3 0 (0.0%) Post Tuberculosis Addison’s Disease 5 0 (0.0%) Total 2/291 (0.7%) Clinical sensitivity and specificity in this sample cohort are summarized in the following table: Diagnosis Positive Negative Total KRONUS 21-OHAb ELISA Kit Positive:� ≥45 94 2 96 Negative: <45 14 289 303 Total 108 291 399 Clinical sensitivity: 87.0% (94/108) 95% CI: 79.4% to 92.2% Clinical specificity: 99.3% (289/291) 95% CI: 97.5% to 99.8% 15
b. Other clinical supportive data (when a. and b. are not applicable): Not applicable 4. Clinical cut-off: See assay cut-off. 5. Expected values/Reference range: The expected values of 21-OHAb were analyzed in accordance with CLSI guideline C28-A3c using 1082 serum samples from apparently healthy blood donors (85% men, 15% women between the age from 11 to 68 years). The mean age of this cohort was 38.3 years (SD of 13.8). The range of index values obtained was 1.9–
74.7 with a mean index value of 7.2 (SD of 4.56). The upper limit of the reference range was determined using the non-parametric calculations. The�97.5th�percentile�
value�for�all�samples�was�17.1 (90%�CI:16.0–22.3).� A�total�of�1080�samples�
(99.8%)�were�negative�for�21-OHAb�and�two�samples�positive� for�21-OHAb�(0.2%)�
have�index�values�of�65.7�and�74.7.�It�is�the�responsibility� of�each�laboratory� to�
establish�its�own�reference�ranges�for�the�population� of�patients�it�serves,�as�
expected�values�are�affected�by�many�different�factors.�
N. Proposed Labeling: The�labeling� is�sufficient� and�it�satisfies�the�requirements�of�21�CFR�Part�809.10.�
O. Conclusion: The�submitted� information� in�this�premarket�notification� is�complete�and�supports�a�
substantial� equivalence� decision.�
Proposed labeling: |
idK180209_s0_e2000 | K180209.txt | purpose for submission | New Device | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k180209 B. Purpose for Submission: New Device C. Measurand: 1,5-Anhydroglucitol (1,5-AG) D. Type of Test: Quantitative, colorometric, pyranose oxidase (PROD) E. Applicant: Diazyme Laboratories Inc. F. Proprietary and Established Names: Diazyme 1,5-AG Assay G. Regulatory Information: 1. Regulation section: 21 CFR 864.7470; Glycosylated hemoglobin assay 2. Classification: Class II 3. Product code: NOZ; Assay, 1,5-Anhydroglucitol 4. Panel: Hematology (81) 2
H. Intended Use: 1. Intended use(s): See indications for use below. 2. Indication(s) for use: Diazyme 1,5-anhydroglucitol (1,5-AG) Assay is an enzymatic method intended for the quantitative determination of 1,5-anhydroglucitol (1,5-AG) in serum or plasma. The 1,5-
AG Assay is for the intermediate term (preceding 1-2 weeks) monitoring of glycemic control in people with diabetes. For in vitro diagnostic use only. 3. Special conditions for use statement(s): · For in vitro diagnostic use only · Prescription use only 4. Special instrument requirements: Beckman AU680 I. Device Description: Diazyme’s 1,5-AG Assay is an enzymatic method consisting of a two-reagent test kit (Reagent 1 and Reagent 2) and is to be used with a fully automated chemistry analyzer. The test system also includes a calibration standard and a two-level control set, both of which are purchased separately. J. Substantial Equivalence Information: 1. Predicate device name(s): GlycoMark 2. Predicate 510(k) number(s): k031604 3. Comparison with predicate: Similarities/Differences Item Diazyme 1,5-AG Assay GlycoMark™ (K031604) Indications for use The intermediate term monitoring of glycemic Same 3
Similarities/Differences
Item Diazyme 1,5-AG Assay GlycoMark™ (K031604) control in people with diabetes Sample
Serum or plasma
Same Test principle Pyranose
oxidase (PROD)
Same Linearity
0.5-110 ug/mL
Same Methodology
Colorimetric
Same Instruments
Beckman AU680
Roche Hitachi 917
K. Standard/Guidance Document Referenced (if applicable):
Clinical and Laboratory Standards Institute EP5-
Clinical and Laboratory Standards Institute EP6-A – Evaluation of the Linearity of Quantitative Analytical Methods; Approved (2003) A2 –
Clinical and Laboratory Standards Institute EP7-A2 – Interference Testing in Clinical Chemistry; Approved Guideline (2002) Evaluation of Precision Performance Clinical and Laboratory Standards Institute EP17-A2: Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline of Clinical Chemistry Devices
Clinical and Laboratory Standards Institute C28-A3 – Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline, Third Edition -
L. Test Principle: Approved Guideline
Diazyme’s 1,5-AG assay uses the enzyme pyranose oxidase (PROD) to oxidize the 2nd position hydroxyl group of 1,5-AG and to detect the generated hydrogen peroxide by colorimetry using peroxidase (POD). To eliminate reactive glucose in sample, it is pretreated by enzymatic reactions using hexokinase and pyruvate kinase (PK). Hexokinase uses adenosine triphosphate (ATP) to convert glucose into non-reactive glucose-6-phosphate (G-
6-P), generating adenosine diphosphate (ADP). The reaction is driven to completion with PK, as ADP is phosphorylated to ATP during the conversion of phosphoenolpyruvate (PEP) into pyruvate. -
M. Performance Characteristics (if/when applicable): Second Edition
Analytical performance: 1.
2.
a. Precision/Reproducibility: 4
Precision studies were performed using six serum samples containing the following concentrations of 1,5-AG: 3.1, 5.7, 11.6, 23.2, 61.8 and 97.3 ug/mL. Two levels of quality control (QC) material (3.6 and 12.3 ug/mL) and one level of calibrator solution (21.1 ug/mL) were also tested. Samples were tested in duplicate using three reagent lots over 20 days with two runs per day (20x2x2 design). Samples were analyzed using the Diazyme 1,5-AG Assay run on a Beckman AU680 analyzer. The results of data analysis of the combined three lots (n=240) are summarized below: Sample Mean Within-run Between- Run Between-Day Between-Lot Total SD % CV SD % CV SD % CV SD % CV SD % CV QC1 3.6 0.07 2.0 0.05 1.4 0.03 0.7 0.09 2.5 0.09 2.5 QC2 12.3 0.09 0.8 0.10 0.8 0.03 0.3 0.14 1.1 0.14 1.1 Calibrator 21.2 0.12 0.6 0.11 0.5 0.09 0.4 0.18 0.9 0.19 0.9 Serum 1 3.1 0.07 2.3 0.07 2.3 0.11 3.5 0.14 4.7 0.15 4.8 Serum 2 5.7 0.07 1.3 0.08 1.4 0.07 1.2 0.13 2.2 0.13 2.2 Serum 3 11.6 0.09 0.8 0.11 1.0 0.05 0.5 0.15 0.3 0.15 1.3 Serum 4 23.2 0.14 0.6 0.15 0.6 0.07 0.3 0.22 0.9 0.22 0.9 Serum 5 61.8 0.32 0.5 0.36 0.6 0.42 0.7 0.63 1.0 0.64 1.0 Serum 6 97.3 0.48 0.5 0.51 0.5 0.62 0.6 0.93 1.0 0.94 1.0 b. Linearity/assay reportable range: Linearity was evaluated using high and low 1,5-AG serum pools that were mixed to create the following eleven samples containing 1,5-AG concentrations spanning the measuring range: 0.2, 10.9, 22.1, 34.4, 45.3, 58.5, 68.6, 81.1, 92.7, 103.2, and 116.7 ug/mL 1,5-AG. Samples were measured in triplicate using one lot of reagent on a Beckman AU860 analyzer. The results of the linear regression analysis are summarized below: y = 1.0014x – 0.8351, R2 = 0.9998 The results of the linearity study support the claimed measuring range of 0.5 to 110 ug/mL. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability: The Diazyme 1,5-AG Assay is traceable to an internal standard manufactured using highly purified 1,5-AG, referred to as the Master Calibrator. The Master Calibrator was prepared by spiking the appropriate amount of pure 1,5-AG into a phosphate buffer solution. The Master Calibrator was subsequently value assigned. d. Detection limit: The Limit of Blank (LoB) study was performed with five serum samples, which were dialyzed to removed endogenous 1,5-AG, and two reagent lots. The samples were 5
tested in quadruplicate over three days (n=60 samples per reagent lot). The LoB was determined to be 0.3 ug/mL. The Limit of Detection (LoD) study was performed with five serum samples that were prepared by diluting native serum samples with serum that was dialyzed to removed endogenous 1,5-AG, with two reagent lots. Samples were tested in quadruplicate over three days (n=60 samples per reagent lot). The LoD was calculated as the LoB + (1.653 * SD of LoD samples). The LoD was determined to be 0.45 ug/mL. The Limit of Quantitation (LoQ) study was performed using five serum samples ranging from approximately 1 to 16 times the claimed LoB. Samples were either native serum or serum diluted with dialyzed serum to obtain the relevant 1
Purpose for submission: |
idK180209_s0_e2000 | K180209.txt | measurand | 1,5-Anhydroglucitol (1,5-AG) | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k180209 B. Purpose for Submission: New Device C. Measurand: 1,5-Anhydroglucitol (1,5-AG) D. Type of Test: Quantitative, colorometric, pyranose oxidase (PROD) E. Applicant: Diazyme Laboratories Inc. F. Proprietary and Established Names: Diazyme 1,5-AG Assay G. Regulatory Information: 1. Regulation section: 21 CFR 864.7470; Glycosylated hemoglobin assay 2. Classification: Class II 3. Product code: NOZ; Assay, 1,5-Anhydroglucitol 4. Panel: Hematology (81) 2
H. Intended Use: 1. Intended use(s): See indications for use below. 2. Indication(s) for use: Diazyme 1,5-anhydroglucitol (1,5-AG) Assay is an enzymatic method intended for the quantitative determination of 1,5-anhydroglucitol (1,5-AG) in serum or plasma. The 1,5-
AG Assay is for the intermediate term (preceding 1-2 weeks) monitoring of glycemic control in people with diabetes. For in vitro diagnostic use only. 3. Special conditions for use statement(s): · For in vitro diagnostic use only · Prescription use only 4. Special instrument requirements: Beckman AU680 I. Device Description: Diazyme’s 1,5-AG Assay is an enzymatic method consisting of a two-reagent test kit (Reagent 1 and Reagent 2) and is to be used with a fully automated chemistry analyzer. The test system also includes a calibration standard and a two-level control set, both of which are purchased separately. J. Substantial Equivalence Information: 1. Predicate device name(s): GlycoMark 2. Predicate 510(k) number(s): k031604 3. Comparison with predicate: Similarities/Differences Item Diazyme 1,5-AG Assay GlycoMark™ (K031604) Indications for use The intermediate term monitoring of glycemic Same 3
Similarities/Differences
Item Diazyme 1,5-AG Assay GlycoMark™ (K031604) control in people with diabetes Sample
Serum or plasma
Same Test principle Pyranose
oxidase (PROD)
Same Linearity
0.5-110 ug/mL
Same Methodology
Colorimetric
Same Instruments
Beckman AU680
Roche Hitachi 917
K. Standard/Guidance Document Referenced (if applicable):
Clinical and Laboratory Standards Institute EP5-
Clinical and Laboratory Standards Institute EP6-A – Evaluation of the Linearity of Quantitative Analytical Methods; Approved (2003) A2 –
Clinical and Laboratory Standards Institute EP7-A2 – Interference Testing in Clinical Chemistry; Approved Guideline (2002) Evaluation of Precision Performance Clinical and Laboratory Standards Institute EP17-A2: Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline of Clinical Chemistry Devices
Clinical and Laboratory Standards Institute C28-A3 – Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline, Third Edition -
L. Test Principle: Approved Guideline
Diazyme’s 1,5-AG assay uses the enzyme pyranose oxidase (PROD) to oxidize the 2nd position hydroxyl group of 1,5-AG and to detect the generated hydrogen peroxide by colorimetry using peroxidase (POD). To eliminate reactive glucose in sample, it is pretreated by enzymatic reactions using hexokinase and pyruvate kinase (PK). Hexokinase uses adenosine triphosphate (ATP) to convert glucose into non-reactive glucose-6-phosphate (G-
6-P), generating adenosine diphosphate (ADP). The reaction is driven to completion with PK, as ADP is phosphorylated to ATP during the conversion of phosphoenolpyruvate (PEP) into pyruvate. -
M. Performance Characteristics (if/when applicable): Second Edition
Analytical performance: 1.
2.
a. Precision/Reproducibility: 4
Precision studies were performed using six serum samples containing the following concentrations of 1,5-AG: 3.1, 5.7, 11.6, 23.2, 61.8 and 97.3 ug/mL. Two levels of quality control (QC) material (3.6 and 12.3 ug/mL) and one level of calibrator solution (21.1 ug/mL) were also tested. Samples were tested in duplicate using three reagent lots over 20 days with two runs per day (20x2x2 design). Samples were analyzed using the Diazyme 1,5-AG Assay run on a Beckman AU680 analyzer. The results of data analysis of the combined three lots (n=240) are summarized below: Sample Mean Within-run Between- Run Between-Day Between-Lot Total SD % CV SD % CV SD % CV SD % CV SD % CV QC1 3.6 0.07 2.0 0.05 1.4 0.03 0.7 0.09 2.5 0.09 2.5 QC2 12.3 0.09 0.8 0.10 0.8 0.03 0.3 0.14 1.1 0.14 1.1 Calibrator 21.2 0.12 0.6 0.11 0.5 0.09 0.4 0.18 0.9 0.19 0.9 Serum 1 3.1 0.07 2.3 0.07 2.3 0.11 3.5 0.14 4.7 0.15 4.8 Serum 2 5.7 0.07 1.3 0.08 1.4 0.07 1.2 0.13 2.2 0.13 2.2 Serum 3 11.6 0.09 0.8 0.11 1.0 0.05 0.5 0.15 0.3 0.15 1.3 Serum 4 23.2 0.14 0.6 0.15 0.6 0.07 0.3 0.22 0.9 0.22 0.9 Serum 5 61.8 0.32 0.5 0.36 0.6 0.42 0.7 0.63 1.0 0.64 1.0 Serum 6 97.3 0.48 0.5 0.51 0.5 0.62 0.6 0.93 1.0 0.94 1.0 b. Linearity/assay reportable range: Linearity was evaluated using high and low 1,5-AG serum pools that were mixed to create the following eleven samples containing 1,5-AG concentrations spanning the measuring range: 0.2, 10.9, 22.1, 34.4, 45.3, 58.5, 68.6, 81.1, 92.7, 103.2, and 116.7 ug/mL 1,5-AG. Samples were measured in triplicate using one lot of reagent on a Beckman AU860 analyzer. The results of the linear regression analysis are summarized below: y = 1.0014x – 0.8351, R2 = 0.9998 The results of the linearity study support the claimed measuring range of 0.5 to 110 ug/mL. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability: The Diazyme 1,5-AG Assay is traceable to an internal standard manufactured using highly purified 1,5-AG, referred to as the Master Calibrator. The Master Calibrator was prepared by spiking the appropriate amount of pure 1,5-AG into a phosphate buffer solution. The Master Calibrator was subsequently value assigned. d. Detection limit: The Limit of Blank (LoB) study was performed with five serum samples, which were dialyzed to removed endogenous 1,5-AG, and two reagent lots. The samples were 5
tested in quadruplicate over three days (n=60 samples per reagent lot). The LoB was determined to be 0.3 ug/mL. The Limit of Detection (LoD) study was performed with five serum samples that were prepared by diluting native serum samples with serum that was dialyzed to removed endogenous 1,5-AG, with two reagent lots. Samples were tested in quadruplicate over three days (n=60 samples per reagent lot). The LoD was calculated as the LoB + (1.653 * SD of LoD samples). The LoD was determined to be 0.45 ug/mL. The Limit of Quantitation (LoQ) study was performed using five serum samples ranging from approximately 1 to 16 times the claimed LoB. Samples were either native serum or serum diluted with dialyzed serum to obtain the relevant 1
Measurand: |
idK180209_s0_e2000 | K180209.txt | type of test | Quantitative, colorometric, pyranose oxidase (PROD) | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k180209 B. Purpose for Submission: New Device C. Measurand: 1,5-Anhydroglucitol (1,5-AG) D. Type of Test: Quantitative, colorometric, pyranose oxidase (PROD) E. Applicant: Diazyme Laboratories Inc. F. Proprietary and Established Names: Diazyme 1,5-AG Assay G. Regulatory Information: 1. Regulation section: 21 CFR 864.7470; Glycosylated hemoglobin assay 2. Classification: Class II 3. Product code: NOZ; Assay, 1,5-Anhydroglucitol 4. Panel: Hematology (81) 2
H. Intended Use: 1. Intended use(s): See indications for use below. 2. Indication(s) for use: Diazyme 1,5-anhydroglucitol (1,5-AG) Assay is an enzymatic method intended for the quantitative determination of 1,5-anhydroglucitol (1,5-AG) in serum or plasma. The 1,5-
AG Assay is for the intermediate term (preceding 1-2 weeks) monitoring of glycemic control in people with diabetes. For in vitro diagnostic use only. 3. Special conditions for use statement(s): · For in vitro diagnostic use only · Prescription use only 4. Special instrument requirements: Beckman AU680 I. Device Description: Diazyme’s 1,5-AG Assay is an enzymatic method consisting of a two-reagent test kit (Reagent 1 and Reagent 2) and is to be used with a fully automated chemistry analyzer. The test system also includes a calibration standard and a two-level control set, both of which are purchased separately. J. Substantial Equivalence Information: 1. Predicate device name(s): GlycoMark 2. Predicate 510(k) number(s): k031604 3. Comparison with predicate: Similarities/Differences Item Diazyme 1,5-AG Assay GlycoMark™ (K031604) Indications for use The intermediate term monitoring of glycemic Same 3
Similarities/Differences
Item Diazyme 1,5-AG Assay GlycoMark™ (K031604) control in people with diabetes Sample
Serum or plasma
Same Test principle Pyranose
oxidase (PROD)
Same Linearity
0.5-110 ug/mL
Same Methodology
Colorimetric
Same Instruments
Beckman AU680
Roche Hitachi 917
K. Standard/Guidance Document Referenced (if applicable):
Clinical and Laboratory Standards Institute EP5-
Clinical and Laboratory Standards Institute EP6-A – Evaluation of the Linearity of Quantitative Analytical Methods; Approved (2003) A2 –
Clinical and Laboratory Standards Institute EP7-A2 – Interference Testing in Clinical Chemistry; Approved Guideline (2002) Evaluation of Precision Performance Clinical and Laboratory Standards Institute EP17-A2: Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline of Clinical Chemistry Devices
Clinical and Laboratory Standards Institute C28-A3 – Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline, Third Edition -
L. Test Principle: Approved Guideline
Diazyme’s 1,5-AG assay uses the enzyme pyranose oxidase (PROD) to oxidize the 2nd position hydroxyl group of 1,5-AG and to detect the generated hydrogen peroxide by colorimetry using peroxidase (POD). To eliminate reactive glucose in sample, it is pretreated by enzymatic reactions using hexokinase and pyruvate kinase (PK). Hexokinase uses adenosine triphosphate (ATP) to convert glucose into non-reactive glucose-6-phosphate (G-
6-P), generating adenosine diphosphate (ADP). The reaction is driven to completion with PK, as ADP is phosphorylated to ATP during the conversion of phosphoenolpyruvate (PEP) into pyruvate. -
M. Performance Characteristics (if/when applicable): Second Edition
Analytical performance: 1.
2.
a. Precision/Reproducibility: 4
Precision studies were performed using six serum samples containing the following concentrations of 1,5-AG: 3.1, 5.7, 11.6, 23.2, 61.8 and 97.3 ug/mL. Two levels of quality control (QC) material (3.6 and 12.3 ug/mL) and one level of calibrator solution (21.1 ug/mL) were also tested. Samples were tested in duplicate using three reagent lots over 20 days with two runs per day (20x2x2 design). Samples were analyzed using the Diazyme 1,5-AG Assay run on a Beckman AU680 analyzer. The results of data analysis of the combined three lots (n=240) are summarized below: Sample Mean Within-run Between- Run Between-Day Between-Lot Total SD % CV SD % CV SD % CV SD % CV SD % CV QC1 3.6 0.07 2.0 0.05 1.4 0.03 0.7 0.09 2.5 0.09 2.5 QC2 12.3 0.09 0.8 0.10 0.8 0.03 0.3 0.14 1.1 0.14 1.1 Calibrator 21.2 0.12 0.6 0.11 0.5 0.09 0.4 0.18 0.9 0.19 0.9 Serum 1 3.1 0.07 2.3 0.07 2.3 0.11 3.5 0.14 4.7 0.15 4.8 Serum 2 5.7 0.07 1.3 0.08 1.4 0.07 1.2 0.13 2.2 0.13 2.2 Serum 3 11.6 0.09 0.8 0.11 1.0 0.05 0.5 0.15 0.3 0.15 1.3 Serum 4 23.2 0.14 0.6 0.15 0.6 0.07 0.3 0.22 0.9 0.22 0.9 Serum 5 61.8 0.32 0.5 0.36 0.6 0.42 0.7 0.63 1.0 0.64 1.0 Serum 6 97.3 0.48 0.5 0.51 0.5 0.62 0.6 0.93 1.0 0.94 1.0 b. Linearity/assay reportable range: Linearity was evaluated using high and low 1,5-AG serum pools that were mixed to create the following eleven samples containing 1,5-AG concentrations spanning the measuring range: 0.2, 10.9, 22.1, 34.4, 45.3, 58.5, 68.6, 81.1, 92.7, 103.2, and 116.7 ug/mL 1,5-AG. Samples were measured in triplicate using one lot of reagent on a Beckman AU860 analyzer. The results of the linear regression analysis are summarized below: y = 1.0014x – 0.8351, R2 = 0.9998 The results of the linearity study support the claimed measuring range of 0.5 to 110 ug/mL. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability: The Diazyme 1,5-AG Assay is traceable to an internal standard manufactured using highly purified 1,5-AG, referred to as the Master Calibrator. The Master Calibrator was prepared by spiking the appropriate amount of pure 1,5-AG into a phosphate buffer solution. The Master Calibrator was subsequently value assigned. d. Detection limit: The Limit of Blank (LoB) study was performed with five serum samples, which were dialyzed to removed endogenous 1,5-AG, and two reagent lots. The samples were 5
tested in quadruplicate over three days (n=60 samples per reagent lot). The LoB was determined to be 0.3 ug/mL. The Limit of Detection (LoD) study was performed with five serum samples that were prepared by diluting native serum samples with serum that was dialyzed to removed endogenous 1,5-AG, with two reagent lots. Samples were tested in quadruplicate over three days (n=60 samples per reagent lot). The LoD was calculated as the LoB + (1.653 * SD of LoD samples). The LoD was determined to be 0.45 ug/mL. The Limit of Quantitation (LoQ) study was performed using five serum samples ranging from approximately 1 to 16 times the claimed LoB. Samples were either native serum or serum diluted with dialyzed serum to obtain the relevant 1
Type of test: |
idK180209_s0_e2000 | K180209.txt | classification | Class II | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k180209 B. Purpose for Submission: New Device C. Measurand: 1,5-Anhydroglucitol (1,5-AG) D. Type of Test: Quantitative, colorometric, pyranose oxidase (PROD) E. Applicant: Diazyme Laboratories Inc. F. Proprietary and Established Names: Diazyme 1,5-AG Assay G. Regulatory Information: 1. Regulation section: 21 CFR 864.7470; Glycosylated hemoglobin assay 2. Classification: Class II 3. Product code: NOZ; Assay, 1,5-Anhydroglucitol 4. Panel: Hematology (81) 2
H. Intended Use: 1. Intended use(s): See indications for use below. 2. Indication(s) for use: Diazyme 1,5-anhydroglucitol (1,5-AG) Assay is an enzymatic method intended for the quantitative determination of 1,5-anhydroglucitol (1,5-AG) in serum or plasma. The 1,5-
AG Assay is for the intermediate term (preceding 1-2 weeks) monitoring of glycemic control in people with diabetes. For in vitro diagnostic use only. 3. Special conditions for use statement(s): · For in vitro diagnostic use only · Prescription use only 4. Special instrument requirements: Beckman AU680 I. Device Description: Diazyme’s 1,5-AG Assay is an enzymatic method consisting of a two-reagent test kit (Reagent 1 and Reagent 2) and is to be used with a fully automated chemistry analyzer. The test system also includes a calibration standard and a two-level control set, both of which are purchased separately. J. Substantial Equivalence Information: 1. Predicate device name(s): GlycoMark 2. Predicate 510(k) number(s): k031604 3. Comparison with predicate: Similarities/Differences Item Diazyme 1,5-AG Assay GlycoMark™ (K031604) Indications for use The intermediate term monitoring of glycemic Same 3
Similarities/Differences
Item Diazyme 1,5-AG Assay GlycoMark™ (K031604) control in people with diabetes Sample
Serum or plasma
Same Test principle Pyranose
oxidase (PROD)
Same Linearity
0.5-110 ug/mL
Same Methodology
Colorimetric
Same Instruments
Beckman AU680
Roche Hitachi 917
K. Standard/Guidance Document Referenced (if applicable):
Clinical and Laboratory Standards Institute EP5-
Clinical and Laboratory Standards Institute EP6-A – Evaluation of the Linearity of Quantitative Analytical Methods; Approved (2003) A2 –
Clinical and Laboratory Standards Institute EP7-A2 – Interference Testing in Clinical Chemistry; Approved Guideline (2002) Evaluation of Precision Performance Clinical and Laboratory Standards Institute EP17-A2: Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline of Clinical Chemistry Devices
Clinical and Laboratory Standards Institute C28-A3 – Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline, Third Edition -
L. Test Principle: Approved Guideline
Diazyme’s 1,5-AG assay uses the enzyme pyranose oxidase (PROD) to oxidize the 2nd position hydroxyl group of 1,5-AG and to detect the generated hydrogen peroxide by colorimetry using peroxidase (POD). To eliminate reactive glucose in sample, it is pretreated by enzymatic reactions using hexokinase and pyruvate kinase (PK). Hexokinase uses adenosine triphosphate (ATP) to convert glucose into non-reactive glucose-6-phosphate (G-
6-P), generating adenosine diphosphate (ADP). The reaction is driven to completion with PK, as ADP is phosphorylated to ATP during the conversion of phosphoenolpyruvate (PEP) into pyruvate. -
M. Performance Characteristics (if/when applicable): Second Edition
Analytical performance: 1.
2.
a. Precision/Reproducibility: 4
Precision studies were performed using six serum samples containing the following concentrations of 1,5-AG: 3.1, 5.7, 11.6, 23.2, 61.8 and 97.3 ug/mL. Two levels of quality control (QC) material (3.6 and 12.3 ug/mL) and one level of calibrator solution (21.1 ug/mL) were also tested. Samples were tested in duplicate using three reagent lots over 20 days with two runs per day (20x2x2 design). Samples were analyzed using the Diazyme 1,5-AG Assay run on a Beckman AU680 analyzer. The results of data analysis of the combined three lots (n=240) are summarized below: Sample Mean Within-run Between- Run Between-Day Between-Lot Total SD % CV SD % CV SD % CV SD % CV SD % CV QC1 3.6 0.07 2.0 0.05 1.4 0.03 0.7 0.09 2.5 0.09 2.5 QC2 12.3 0.09 0.8 0.10 0.8 0.03 0.3 0.14 1.1 0.14 1.1 Calibrator 21.2 0.12 0.6 0.11 0.5 0.09 0.4 0.18 0.9 0.19 0.9 Serum 1 3.1 0.07 2.3 0.07 2.3 0.11 3.5 0.14 4.7 0.15 4.8 Serum 2 5.7 0.07 1.3 0.08 1.4 0.07 1.2 0.13 2.2 0.13 2.2 Serum 3 11.6 0.09 0.8 0.11 1.0 0.05 0.5 0.15 0.3 0.15 1.3 Serum 4 23.2 0.14 0.6 0.15 0.6 0.07 0.3 0.22 0.9 0.22 0.9 Serum 5 61.8 0.32 0.5 0.36 0.6 0.42 0.7 0.63 1.0 0.64 1.0 Serum 6 97.3 0.48 0.5 0.51 0.5 0.62 0.6 0.93 1.0 0.94 1.0 b. Linearity/assay reportable range: Linearity was evaluated using high and low 1,5-AG serum pools that were mixed to create the following eleven samples containing 1,5-AG concentrations spanning the measuring range: 0.2, 10.9, 22.1, 34.4, 45.3, 58.5, 68.6, 81.1, 92.7, 103.2, and 116.7 ug/mL 1,5-AG. Samples were measured in triplicate using one lot of reagent on a Beckman AU860 analyzer. The results of the linear regression analysis are summarized below: y = 1.0014x – 0.8351, R2 = 0.9998 The results of the linearity study support the claimed measuring range of 0.5 to 110 ug/mL. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability: The Diazyme 1,5-AG Assay is traceable to an internal standard manufactured using highly purified 1,5-AG, referred to as the Master Calibrator. The Master Calibrator was prepared by spiking the appropriate amount of pure 1,5-AG into a phosphate buffer solution. The Master Calibrator was subsequently value assigned. d. Detection limit: The Limit of Blank (LoB) study was performed with five serum samples, which were dialyzed to removed endogenous 1,5-AG, and two reagent lots. The samples were 5
tested in quadruplicate over three days (n=60 samples per reagent lot). The LoB was determined to be 0.3 ug/mL. The Limit of Detection (LoD) study was performed with five serum samples that were prepared by diluting native serum samples with serum that was dialyzed to removed endogenous 1,5-AG, with two reagent lots. Samples were tested in quadruplicate over three days (n=60 samples per reagent lot). The LoD was calculated as the LoB + (1.653 * SD of LoD samples). The LoD was determined to be 0.45 ug/mL. The Limit of Quantitation (LoQ) study was performed using five serum samples ranging from approximately 1 to 16 times the claimed LoB. Samples were either native serum or serum diluted with dialyzed serum to obtain the relevant 1
Classification: |
idK180209_s0_e2000 | K180209.txt | product code | NOZ; Assay, 1,5-Anhydroglucitol | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k180209 B. Purpose for Submission: New Device C. Measurand: 1,5-Anhydroglucitol (1,5-AG) D. Type of Test: Quantitative, colorometric, pyranose oxidase (PROD) E. Applicant: Diazyme Laboratories Inc. F. Proprietary and Established Names: Diazyme 1,5-AG Assay G. Regulatory Information: 1. Regulation section: 21 CFR 864.7470; Glycosylated hemoglobin assay 2. Classification: Class II 3. Product code: NOZ; Assay, 1,5-Anhydroglucitol 4. Panel: Hematology (81) 2
H. Intended Use: 1. Intended use(s): See indications for use below. 2. Indication(s) for use: Diazyme 1,5-anhydroglucitol (1,5-AG) Assay is an enzymatic method intended for the quantitative determination of 1,5-anhydroglucitol (1,5-AG) in serum or plasma. The 1,5-
AG Assay is for the intermediate term (preceding 1-2 weeks) monitoring of glycemic control in people with diabetes. For in vitro diagnostic use only. 3. Special conditions for use statement(s): · For in vitro diagnostic use only · Prescription use only 4. Special instrument requirements: Beckman AU680 I. Device Description: Diazyme’s 1,5-AG Assay is an enzymatic method consisting of a two-reagent test kit (Reagent 1 and Reagent 2) and is to be used with a fully automated chemistry analyzer. The test system also includes a calibration standard and a two-level control set, both of which are purchased separately. J. Substantial Equivalence Information: 1. Predicate device name(s): GlycoMark 2. Predicate 510(k) number(s): k031604 3. Comparison with predicate: Similarities/Differences Item Diazyme 1,5-AG Assay GlycoMark™ (K031604) Indications for use The intermediate term monitoring of glycemic Same 3
Similarities/Differences
Item Diazyme 1,5-AG Assay GlycoMark™ (K031604) control in people with diabetes Sample
Serum or plasma
Same Test principle Pyranose
oxidase (PROD)
Same Linearity
0.5-110 ug/mL
Same Methodology
Colorimetric
Same Instruments
Beckman AU680
Roche Hitachi 917
K. Standard/Guidance Document Referenced (if applicable):
Clinical and Laboratory Standards Institute EP5-
Clinical and Laboratory Standards Institute EP6-A – Evaluation of the Linearity of Quantitative Analytical Methods; Approved (2003) A2 –
Clinical and Laboratory Standards Institute EP7-A2 – Interference Testing in Clinical Chemistry; Approved Guideline (2002) Evaluation of Precision Performance Clinical and Laboratory Standards Institute EP17-A2: Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline of Clinical Chemistry Devices
Clinical and Laboratory Standards Institute C28-A3 – Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline, Third Edition -
L. Test Principle: Approved Guideline
Diazyme’s 1,5-AG assay uses the enzyme pyranose oxidase (PROD) to oxidize the 2nd position hydroxyl group of 1,5-AG and to detect the generated hydrogen peroxide by colorimetry using peroxidase (POD). To eliminate reactive glucose in sample, it is pretreated by enzymatic reactions using hexokinase and pyruvate kinase (PK). Hexokinase uses adenosine triphosphate (ATP) to convert glucose into non-reactive glucose-6-phosphate (G-
6-P), generating adenosine diphosphate (ADP). The reaction is driven to completion with PK, as ADP is phosphorylated to ATP during the conversion of phosphoenolpyruvate (PEP) into pyruvate. -
M. Performance Characteristics (if/when applicable): Second Edition
Analytical performance: 1.
2.
a. Precision/Reproducibility: 4
Precision studies were performed using six serum samples containing the following concentrations of 1,5-AG: 3.1, 5.7, 11.6, 23.2, 61.8 and 97.3 ug/mL. Two levels of quality control (QC) material (3.6 and 12.3 ug/mL) and one level of calibrator solution (21.1 ug/mL) were also tested. Samples were tested in duplicate using three reagent lots over 20 days with two runs per day (20x2x2 design). Samples were analyzed using the Diazyme 1,5-AG Assay run on a Beckman AU680 analyzer. The results of data analysis of the combined three lots (n=240) are summarized below: Sample Mean Within-run Between- Run Between-Day Between-Lot Total SD % CV SD % CV SD % CV SD % CV SD % CV QC1 3.6 0.07 2.0 0.05 1.4 0.03 0.7 0.09 2.5 0.09 2.5 QC2 12.3 0.09 0.8 0.10 0.8 0.03 0.3 0.14 1.1 0.14 1.1 Calibrator 21.2 0.12 0.6 0.11 0.5 0.09 0.4 0.18 0.9 0.19 0.9 Serum 1 3.1 0.07 2.3 0.07 2.3 0.11 3.5 0.14 4.7 0.15 4.8 Serum 2 5.7 0.07 1.3 0.08 1.4 0.07 1.2 0.13 2.2 0.13 2.2 Serum 3 11.6 0.09 0.8 0.11 1.0 0.05 0.5 0.15 0.3 0.15 1.3 Serum 4 23.2 0.14 0.6 0.15 0.6 0.07 0.3 0.22 0.9 0.22 0.9 Serum 5 61.8 0.32 0.5 0.36 0.6 0.42 0.7 0.63 1.0 0.64 1.0 Serum 6 97.3 0.48 0.5 0.51 0.5 0.62 0.6 0.93 1.0 0.94 1.0 b. Linearity/assay reportable range: Linearity was evaluated using high and low 1,5-AG serum pools that were mixed to create the following eleven samples containing 1,5-AG concentrations spanning the measuring range: 0.2, 10.9, 22.1, 34.4, 45.3, 58.5, 68.6, 81.1, 92.7, 103.2, and 116.7 ug/mL 1,5-AG. Samples were measured in triplicate using one lot of reagent on a Beckman AU860 analyzer. The results of the linear regression analysis are summarized below: y = 1.0014x – 0.8351, R2 = 0.9998 The results of the linearity study support the claimed measuring range of 0.5 to 110 ug/mL. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability: The Diazyme 1,5-AG Assay is traceable to an internal standard manufactured using highly purified 1,5-AG, referred to as the Master Calibrator. The Master Calibrator was prepared by spiking the appropriate amount of pure 1,5-AG into a phosphate buffer solution. The Master Calibrator was subsequently value assigned. d. Detection limit: The Limit of Blank (LoB) study was performed with five serum samples, which were dialyzed to removed endogenous 1,5-AG, and two reagent lots. The samples were 5
tested in quadruplicate over three days (n=60 samples per reagent lot). The LoB was determined to be 0.3 ug/mL. The Limit of Detection (LoD) study was performed with five serum samples that were prepared by diluting native serum samples with serum that was dialyzed to removed endogenous 1,5-AG, with two reagent lots. Samples were tested in quadruplicate over three days (n=60 samples per reagent lot). The LoD was calculated as the LoB + (1.653 * SD of LoD samples). The LoD was determined to be 0.45 ug/mL. The Limit of Quantitation (LoQ) study was performed using five serum samples ranging from approximately 1 to 16 times the claimed LoB. Samples were either native serum or serum diluted with dialyzed serum to obtain the relevant 1
Product code: |
idK180209_s0_e2000 | K180209.txt | panel | Hematology (81) | (k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k180209 B. Purpose for Submission: New Device C. Measurand: 1,5-Anhydroglucitol (1,5-AG) D. Type of Test: Quantitative, colorometric, pyranose oxidase (PROD) E. Applicant: Diazyme Laboratories Inc. F. Proprietary and Established Names: Diazyme 1,5-AG Assay G. Regulatory Information: 1. Regulation section: 21 CFR 864.7470; Glycosylated hemoglobin assay 2. Classification: Class II 3. Product code: NOZ; Assay, 1,5-Anhydroglucitol 4. Panel: Hematology (81) 2
H. Intended Use: 1. Intended use(s): See indications for use below. 2. Indication(s) for use: Diazyme 1,5-anhydroglucitol (1,5-AG) Assay is an enzymatic method intended for the quantitative determination of 1,5-anhydroglucitol (1,5-AG) in serum or plasma. The 1,5-
AG Assay is for the intermediate term (preceding 1-2 weeks) monitoring of glycemic control in people with diabetes. For in vitro diagnostic use only. 3. Special conditions for use statement(s): · For in vitro diagnostic use only · Prescription use only 4. Special instrument requirements: Beckman AU680 I. Device Description: Diazyme’s 1,5-AG Assay is an enzymatic method consisting of a two-reagent test kit (Reagent 1 and Reagent 2) and is to be used with a fully automated chemistry analyzer. The test system also includes a calibration standard and a two-level control set, both of which are purchased separately. J. Substantial Equivalence Information: 1. Predicate device name(s): GlycoMark 2. Predicate 510(k) number(s): k031604 3. Comparison with predicate: Similarities/Differences Item Diazyme 1,5-AG Assay GlycoMark™ (K031604) Indications for use The intermediate term monitoring of glycemic Same 3
Similarities/Differences
Item Diazyme 1,5-AG Assay GlycoMark™ (K031604) control in people with diabetes Sample
Serum or plasma
Same Test principle Pyranose
oxidase (PROD)
Same Linearity
0.5-110 ug/mL
Same Methodology
Colorimetric
Same Instruments
Beckman AU680
Roche Hitachi 917
K. Standard/Guidance Document Referenced (if applicable):
Clinical and Laboratory Standards Institute EP5-
Clinical and Laboratory Standards Institute EP6-A – Evaluation of the Linearity of Quantitative Analytical Methods; Approved (2003) A2 –
Clinical and Laboratory Standards Institute EP7-A2 – Interference Testing in Clinical Chemistry; Approved Guideline (2002) Evaluation of Precision Performance Clinical and Laboratory Standards Institute EP17-A2: Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline of Clinical Chemistry Devices
Clinical and Laboratory Standards Institute C28-A3 – Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline, Third Edition -
L. Test Principle: Approved Guideline
Diazyme’s 1,5-AG assay uses the enzyme pyranose oxidase (PROD) to oxidize the 2nd position hydroxyl group of 1,5-AG and to detect the generated hydrogen peroxide by colorimetry using peroxidase (POD). To eliminate reactive glucose in sample, it is pretreated by enzymatic reactions using hexokinase and pyruvate kinase (PK). Hexokinase uses adenosine triphosphate (ATP) to convert glucose into non-reactive glucose-6-phosphate (G-
6-P), generating adenosine diphosphate (ADP). The reaction is driven to completion with PK, as ADP is phosphorylated to ATP during the conversion of phosphoenolpyruvate (PEP) into pyruvate. -
M. Performance Characteristics (if/when applicable): Second Edition
Analytical performance: 1.
2.
a. Precision/Reproducibility: 4
Precision studies were performed using six serum samples containing the following concentrations of 1,5-AG: 3.1, 5.7, 11.6, 23.2, 61.8 and 97.3 ug/mL. Two levels of quality control (QC) material (3.6 and 12.3 ug/mL) and one level of calibrator solution (21.1 ug/mL) were also tested. Samples were tested in duplicate using three reagent lots over 20 days with two runs per day (20x2x2 design). Samples were analyzed using the Diazyme 1,5-AG Assay run on a Beckman AU680 analyzer. The results of data analysis of the combined three lots (n=240) are summarized below: Sample Mean Within-run Between- Run Between-Day Between-Lot Total SD % CV SD % CV SD % CV SD % CV SD % CV QC1 3.6 0.07 2.0 0.05 1.4 0.03 0.7 0.09 2.5 0.09 2.5 QC2 12.3 0.09 0.8 0.10 0.8 0.03 0.3 0.14 1.1 0.14 1.1 Calibrator 21.2 0.12 0.6 0.11 0.5 0.09 0.4 0.18 0.9 0.19 0.9 Serum 1 3.1 0.07 2.3 0.07 2.3 0.11 3.5 0.14 4.7 0.15 4.8 Serum 2 5.7 0.07 1.3 0.08 1.4 0.07 1.2 0.13 2.2 0.13 2.2 Serum 3 11.6 0.09 0.8 0.11 1.0 0.05 0.5 0.15 0.3 0.15 1.3 Serum 4 23.2 0.14 0.6 0.15 0.6 0.07 0.3 0.22 0.9 0.22 0.9 Serum 5 61.8 0.32 0.5 0.36 0.6 0.42 0.7 0.63 1.0 0.64 1.0 Serum 6 97.3 0.48 0.5 0.51 0.5 0.62 0.6 0.93 1.0 0.94 1.0 b. Linearity/assay reportable range: Linearity was evaluated using high and low 1,5-AG serum pools that were mixed to create the following eleven samples containing 1,5-AG concentrations spanning the measuring range: 0.2, 10.9, 22.1, 34.4, 45.3, 58.5, 68.6, 81.1, 92.7, 103.2, and 116.7 ug/mL 1,5-AG. Samples were measured in triplicate using one lot of reagent on a Beckman AU860 analyzer. The results of the linear regression analysis are summarized below: y = 1.0014x – 0.8351, R2 = 0.9998 The results of the linearity study support the claimed measuring range of 0.5 to 110 ug/mL. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability: The Diazyme 1,5-AG Assay is traceable to an internal standard manufactured using highly purified 1,5-AG, referred to as the Master Calibrator. The Master Calibrator was prepared by spiking the appropriate amount of pure 1,5-AG into a phosphate buffer solution. The Master Calibrator was subsequently value assigned. d. Detection limit: The Limit of Blank (LoB) study was performed with five serum samples, which were dialyzed to removed endogenous 1,5-AG, and two reagent lots. The samples were 5
tested in quadruplicate over three days (n=60 samples per reagent lot). The LoB was determined to be 0.3 ug/mL. The Limit of Detection (LoD) study was performed with five serum samples that were prepared by diluting native serum samples with serum that was dialyzed to removed endogenous 1,5-AG, with two reagent lots. Samples were tested in quadruplicate over three days (n=60 samples per reagent lot). The LoD was calculated as the LoB + (1.653 * SD of LoD samples). The LoD was determined to be 0.45 ug/mL. The Limit of Quantitation (LoQ) study was performed using five serum samples ranging from approximately 1 to 16 times the claimed LoB. Samples were either native serum or serum diluted with dialyzed serum to obtain the relevant 1
Panel: |
idK180209_s0_e2000 | K180209.txt | intended use | See indications for use below. | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k180209 B. Purpose for Submission: New Device C. Measurand: 1,5-Anhydroglucitol (1,5-AG) D. Type of Test: Quantitative, colorometric, pyranose oxidase (PROD) E. Applicant: Diazyme Laboratories Inc. F. Proprietary and Established Names: Diazyme 1,5-AG Assay G. Regulatory Information: 1. Regulation section: 21 CFR 864.7470; Glycosylated hemoglobin assay 2. Classification: Class II 3. Product code: NOZ; Assay, 1,5-Anhydroglucitol 4. Panel: Hematology (81) 2
H. Intended Use: 1. Intended use(s): See indications for use below. 2. Indication(s) for use: Diazyme 1,5-anhydroglucitol (1,5-AG) Assay is an enzymatic method intended for the quantitative determination of 1,5-anhydroglucitol (1,5-AG) in serum or plasma. The 1,5-
AG Assay is for the intermediate term (preceding 1-2 weeks) monitoring of glycemic control in people with diabetes. For in vitro diagnostic use only. 3. Special conditions for use statement(s): · For in vitro diagnostic use only · Prescription use only 4. Special instrument requirements: Beckman AU680 I. Device Description: Diazyme’s 1,5-AG Assay is an enzymatic method consisting of a two-reagent test kit (Reagent 1 and Reagent 2) and is to be used with a fully automated chemistry analyzer. The test system also includes a calibration standard and a two-level control set, both of which are purchased separately. J. Substantial Equivalence Information: 1. Predicate device name(s): GlycoMark 2. Predicate 510(k) number(s): k031604 3. Comparison with predicate: Similarities/Differences Item Diazyme 1,5-AG Assay GlycoMark™ (K031604) Indications for use The intermediate term monitoring of glycemic Same 3
Similarities/Differences
Item Diazyme 1,5-AG Assay GlycoMark™ (K031604) control in people with diabetes Sample
Serum or plasma
Same Test principle Pyranose
oxidase (PROD)
Same Linearity
0.5-110 ug/mL
Same Methodology
Colorimetric
Same Instruments
Beckman AU680
Roche Hitachi 917
K. Standard/Guidance Document Referenced (if applicable):
Clinical and Laboratory Standards Institute EP5-
Clinical and Laboratory Standards Institute EP6-A – Evaluation of the Linearity of Quantitative Analytical Methods; Approved (2003) A2 –
Clinical and Laboratory Standards Institute EP7-A2 – Interference Testing in Clinical Chemistry; Approved Guideline (2002) Evaluation of Precision Performance Clinical and Laboratory Standards Institute EP17-A2: Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline of Clinical Chemistry Devices
Clinical and Laboratory Standards Institute C28-A3 – Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline, Third Edition -
L. Test Principle: Approved Guideline
Diazyme’s 1,5-AG assay uses the enzyme pyranose oxidase (PROD) to oxidize the 2nd position hydroxyl group of 1,5-AG and to detect the generated hydrogen peroxide by colorimetry using peroxidase (POD). To eliminate reactive glucose in sample, it is pretreated by enzymatic reactions using hexokinase and pyruvate kinase (PK). Hexokinase uses adenosine triphosphate (ATP) to convert glucose into non-reactive glucose-6-phosphate (G-
6-P), generating adenosine diphosphate (ADP). The reaction is driven to completion with PK, as ADP is phosphorylated to ATP during the conversion of phosphoenolpyruvate (PEP) into pyruvate. -
M. Performance Characteristics (if/when applicable): Second Edition
Analytical performance: 1.
2.
a. Precision/Reproducibility: 4
Precision studies were performed using six serum samples containing the following concentrations of 1,5-AG: 3.1, 5.7, 11.6, 23.2, 61.8 and 97.3 ug/mL. Two levels of quality control (QC) material (3.6 and 12.3 ug/mL) and one level of calibrator solution (21.1 ug/mL) were also tested. Samples were tested in duplicate using three reagent lots over 20 days with two runs per day (20x2x2 design). Samples were analyzed using the Diazyme 1,5-AG Assay run on a Beckman AU680 analyzer. The results of data analysis of the combined three lots (n=240) are summarized below: Sample Mean Within-run Between- Run Between-Day Between-Lot Total SD % CV SD % CV SD % CV SD % CV SD % CV QC1 3.6 0.07 2.0 0.05 1.4 0.03 0.7 0.09 2.5 0.09 2.5 QC2 12.3 0.09 0.8 0.10 0.8 0.03 0.3 0.14 1.1 0.14 1.1 Calibrator 21.2 0.12 0.6 0.11 0.5 0.09 0.4 0.18 0.9 0.19 0.9 Serum 1 3.1 0.07 2.3 0.07 2.3 0.11 3.5 0.14 4.7 0.15 4.8 Serum 2 5.7 0.07 1.3 0.08 1.4 0.07 1.2 0.13 2.2 0.13 2.2 Serum 3 11.6 0.09 0.8 0.11 1.0 0.05 0.5 0.15 0.3 0.15 1.3 Serum 4 23.2 0.14 0.6 0.15 0.6 0.07 0.3 0.22 0.9 0.22 0.9 Serum 5 61.8 0.32 0.5 0.36 0.6 0.42 0.7 0.63 1.0 0.64 1.0 Serum 6 97.3 0.48 0.5 0.51 0.5 0.62 0.6 0.93 1.0 0.94 1.0 b. Linearity/assay reportable range: Linearity was evaluated using high and low 1,5-AG serum pools that were mixed to create the following eleven samples containing 1,5-AG concentrations spanning the measuring range: 0.2, 10.9, 22.1, 34.4, 45.3, 58.5, 68.6, 81.1, 92.7, 103.2, and 116.7 ug/mL 1,5-AG. Samples were measured in triplicate using one lot of reagent on a Beckman AU860 analyzer. The results of the linear regression analysis are summarized below: y = 1.0014x – 0.8351, R2 = 0.9998 The results of the linearity study support the claimed measuring range of 0.5 to 110 ug/mL. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability: The Diazyme 1,5-AG Assay is traceable to an internal standard manufactured using highly purified 1,5-AG, referred to as the Master Calibrator. The Master Calibrator was prepared by spiking the appropriate amount of pure 1,5-AG into a phosphate buffer solution. The Master Calibrator was subsequently value assigned. d. Detection limit: The Limit of Blank (LoB) study was performed with five serum samples, which were dialyzed to removed endogenous 1,5-AG, and two reagent lots. The samples were 5
tested in quadruplicate over three days (n=60 samples per reagent lot). The LoB was determined to be 0.3 ug/mL. The Limit of Detection (LoD) study was performed with five serum samples that were prepared by diluting native serum samples with serum that was dialyzed to removed endogenous 1,5-AG, with two reagent lots. Samples were tested in quadruplicate over three days (n=60 samples per reagent lot). The LoD was calculated as the LoB + (1.653 * SD of LoD samples). The LoD was determined to be 0.45 ug/mL. The Limit of Quantitation (LoQ) study was performed using five serum samples ranging from approximately 1 to 16 times the claimed LoB. Samples were either native serum or serum diluted with dialyzed serum to obtain the relevant 1
Intended use: |
idK180209_s0_e2000 | K180209.txt | predicate device name | GlycoMark | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k180209 B. Purpose for Submission: New Device C. Measurand: 1,5-Anhydroglucitol (1,5-AG) D. Type of Test: Quantitative, colorometric, pyranose oxidase (PROD) E. Applicant: Diazyme Laboratories Inc. F. Proprietary and Established Names: Diazyme 1,5-AG Assay G. Regulatory Information: 1. Regulation section: 21 CFR 864.7470; Glycosylated hemoglobin assay 2. Classification: Class II 3. Product code: NOZ; Assay, 1,5-Anhydroglucitol 4. Panel: Hematology (81) 2
H. Intended Use: 1. Intended use(s): See indications for use below. 2. Indication(s) for use: Diazyme 1,5-anhydroglucitol (1,5-AG) Assay is an enzymatic method intended for the quantitative determination of 1,5-anhydroglucitol (1,5-AG) in serum or plasma. The 1,5-
AG Assay is for the intermediate term (preceding 1-2 weeks) monitoring of glycemic control in people with diabetes. For in vitro diagnostic use only. 3. Special conditions for use statement(s): · For in vitro diagnostic use only · Prescription use only 4. Special instrument requirements: Beckman AU680 I. Device Description: Diazyme’s 1,5-AG Assay is an enzymatic method consisting of a two-reagent test kit (Reagent 1 and Reagent 2) and is to be used with a fully automated chemistry analyzer. The test system also includes a calibration standard and a two-level control set, both of which are purchased separately. J. Substantial Equivalence Information: 1. Predicate device name(s): GlycoMark 2. Predicate 510(k) number(s): k031604 3. Comparison with predicate: Similarities/Differences Item Diazyme 1,5-AG Assay GlycoMark™ (K031604) Indications for use The intermediate term monitoring of glycemic Same 3
Similarities/Differences
Item Diazyme 1,5-AG Assay GlycoMark™ (K031604) control in people with diabetes Sample
Serum or plasma
Same Test principle Pyranose
oxidase (PROD)
Same Linearity
0.5-110 ug/mL
Same Methodology
Colorimetric
Same Instruments
Beckman AU680
Roche Hitachi 917
K. Standard/Guidance Document Referenced (if applicable):
Clinical and Laboratory Standards Institute EP5-
Clinical and Laboratory Standards Institute EP6-A – Evaluation of the Linearity of Quantitative Analytical Methods; Approved (2003) A2 –
Clinical and Laboratory Standards Institute EP7-A2 – Interference Testing in Clinical Chemistry; Approved Guideline (2002) Evaluation of Precision Performance Clinical and Laboratory Standards Institute EP17-A2: Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline of Clinical Chemistry Devices
Clinical and Laboratory Standards Institute C28-A3 – Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline, Third Edition -
L. Test Principle: Approved Guideline
Diazyme’s 1,5-AG assay uses the enzyme pyranose oxidase (PROD) to oxidize the 2nd position hydroxyl group of 1,5-AG and to detect the generated hydrogen peroxide by colorimetry using peroxidase (POD). To eliminate reactive glucose in sample, it is pretreated by enzymatic reactions using hexokinase and pyruvate kinase (PK). Hexokinase uses adenosine triphosphate (ATP) to convert glucose into non-reactive glucose-6-phosphate (G-
6-P), generating adenosine diphosphate (ADP). The reaction is driven to completion with PK, as ADP is phosphorylated to ATP during the conversion of phosphoenolpyruvate (PEP) into pyruvate. -
M. Performance Characteristics (if/when applicable): Second Edition
Analytical performance: 1.
2.
a. Precision/Reproducibility: 4
Precision studies were performed using six serum samples containing the following concentrations of 1,5-AG: 3.1, 5.7, 11.6, 23.2, 61.8 and 97.3 ug/mL. Two levels of quality control (QC) material (3.6 and 12.3 ug/mL) and one level of calibrator solution (21.1 ug/mL) were also tested. Samples were tested in duplicate using three reagent lots over 20 days with two runs per day (20x2x2 design). Samples were analyzed using the Diazyme 1,5-AG Assay run on a Beckman AU680 analyzer. The results of data analysis of the combined three lots (n=240) are summarized below: Sample Mean Within-run Between- Run Between-Day Between-Lot Total SD % CV SD % CV SD % CV SD % CV SD % CV QC1 3.6 0.07 2.0 0.05 1.4 0.03 0.7 0.09 2.5 0.09 2.5 QC2 12.3 0.09 0.8 0.10 0.8 0.03 0.3 0.14 1.1 0.14 1.1 Calibrator 21.2 0.12 0.6 0.11 0.5 0.09 0.4 0.18 0.9 0.19 0.9 Serum 1 3.1 0.07 2.3 0.07 2.3 0.11 3.5 0.14 4.7 0.15 4.8 Serum 2 5.7 0.07 1.3 0.08 1.4 0.07 1.2 0.13 2.2 0.13 2.2 Serum 3 11.6 0.09 0.8 0.11 1.0 0.05 0.5 0.15 0.3 0.15 1.3 Serum 4 23.2 0.14 0.6 0.15 0.6 0.07 0.3 0.22 0.9 0.22 0.9 Serum 5 61.8 0.32 0.5 0.36 0.6 0.42 0.7 0.63 1.0 0.64 1.0 Serum 6 97.3 0.48 0.5 0.51 0.5 0.62 0.6 0.93 1.0 0.94 1.0 b. Linearity/assay reportable range: Linearity was evaluated using high and low 1,5-AG serum pools that were mixed to create the following eleven samples containing 1,5-AG concentrations spanning the measuring range: 0.2, 10.9, 22.1, 34.4, 45.3, 58.5, 68.6, 81.1, 92.7, 103.2, and 116.7 ug/mL 1,5-AG. Samples were measured in triplicate using one lot of reagent on a Beckman AU860 analyzer. The results of the linear regression analysis are summarized below: y = 1.0014x – 0.8351, R2 = 0.9998 The results of the linearity study support the claimed measuring range of 0.5 to 110 ug/mL. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability: The Diazyme 1,5-AG Assay is traceable to an internal standard manufactured using highly purified 1,5-AG, referred to as the Master Calibrator. The Master Calibrator was prepared by spiking the appropriate amount of pure 1,5-AG into a phosphate buffer solution. The Master Calibrator was subsequently value assigned. d. Detection limit: The Limit of Blank (LoB) study was performed with five serum samples, which were dialyzed to removed endogenous 1,5-AG, and two reagent lots. The samples were 5
tested in quadruplicate over three days (n=60 samples per reagent lot). The LoB was determined to be 0.3 ug/mL. The Limit of Detection (LoD) study was performed with five serum samples that were prepared by diluting native serum samples with serum that was dialyzed to removed endogenous 1,5-AG, with two reagent lots. Samples were tested in quadruplicate over three days (n=60 samples per reagent lot). The LoD was calculated as the LoB + (1.653 * SD of LoD samples). The LoD was determined to be 0.45 ug/mL. The Limit of Quantitation (LoQ) study was performed using five serum samples ranging from approximately 1 to 16 times the claimed LoB. Samples were either native serum or serum diluted with dialyzed serum to obtain the relevant 1
Predicate device name: |
idK180209_s0_e2000 | K180209.txt | applicant | Diazyme Laboratories Inc. | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k180209 B. Purpose for Submission: New Device C. Measurand: 1,5-Anhydroglucitol (1,5-AG) D. Type of Test: Quantitative, colorometric, pyranose oxidase (PROD) E. Applicant: Diazyme Laboratories Inc. F. Proprietary and Established Names: Diazyme 1,5-AG Assay G. Regulatory Information: 1. Regulation section: 21 CFR 864.7470; Glycosylated hemoglobin assay 2. Classification: Class II 3. Product code: NOZ; Assay, 1,5-Anhydroglucitol 4. Panel: Hematology (81) 2
H. Intended Use: 1. Intended use(s): See indications for use below. 2. Indication(s) for use: Diazyme 1,5-anhydroglucitol (1,5-AG) Assay is an enzymatic method intended for the quantitative determination of 1,5-anhydroglucitol (1,5-AG) in serum or plasma. The 1,5-
AG Assay is for the intermediate term (preceding 1-2 weeks) monitoring of glycemic control in people with diabetes. For in vitro diagnostic use only. 3. Special conditions for use statement(s): · For in vitro diagnostic use only · Prescription use only 4. Special instrument requirements: Beckman AU680 I. Device Description: Diazyme’s 1,5-AG Assay is an enzymatic method consisting of a two-reagent test kit (Reagent 1 and Reagent 2) and is to be used with a fully automated chemistry analyzer. The test system also includes a calibration standard and a two-level control set, both of which are purchased separately. J. Substantial Equivalence Information: 1. Predicate device name(s): GlycoMark 2. Predicate 510(k) number(s): k031604 3. Comparison with predicate: Similarities/Differences Item Diazyme 1,5-AG Assay GlycoMark™ (K031604) Indications for use The intermediate term monitoring of glycemic Same 3
Similarities/Differences
Item Diazyme 1,5-AG Assay GlycoMark™ (K031604) control in people with diabetes Sample
Serum or plasma
Same Test principle Pyranose
oxidase (PROD)
Same Linearity
0.5-110 ug/mL
Same Methodology
Colorimetric
Same Instruments
Beckman AU680
Roche Hitachi 917
K. Standard/Guidance Document Referenced (if applicable):
Clinical and Laboratory Standards Institute EP5-
Clinical and Laboratory Standards Institute EP6-A – Evaluation of the Linearity of Quantitative Analytical Methods; Approved (2003) A2 –
Clinical and Laboratory Standards Institute EP7-A2 – Interference Testing in Clinical Chemistry; Approved Guideline (2002) Evaluation of Precision Performance Clinical and Laboratory Standards Institute EP17-A2: Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline of Clinical Chemistry Devices
Clinical and Laboratory Standards Institute C28-A3 – Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline, Third Edition -
L. Test Principle: Approved Guideline
Diazyme’s 1,5-AG assay uses the enzyme pyranose oxidase (PROD) to oxidize the 2nd position hydroxyl group of 1,5-AG and to detect the generated hydrogen peroxide by colorimetry using peroxidase (POD). To eliminate reactive glucose in sample, it is pretreated by enzymatic reactions using hexokinase and pyruvate kinase (PK). Hexokinase uses adenosine triphosphate (ATP) to convert glucose into non-reactive glucose-6-phosphate (G-
6-P), generating adenosine diphosphate (ADP). The reaction is driven to completion with PK, as ADP is phosphorylated to ATP during the conversion of phosphoenolpyruvate (PEP) into pyruvate. -
M. Performance Characteristics (if/when applicable): Second Edition
Analytical performance: 1.
2.
a. Precision/Reproducibility: 4
Precision studies were performed using six serum samples containing the following concentrations of 1,5-AG: 3.1, 5.7, 11.6, 23.2, 61.8 and 97.3 ug/mL. Two levels of quality control (QC) material (3.6 and 12.3 ug/mL) and one level of calibrator solution (21.1 ug/mL) were also tested. Samples were tested in duplicate using three reagent lots over 20 days with two runs per day (20x2x2 design). Samples were analyzed using the Diazyme 1,5-AG Assay run on a Beckman AU680 analyzer. The results of data analysis of the combined three lots (n=240) are summarized below: Sample Mean Within-run Between- Run Between-Day Between-Lot Total SD % CV SD % CV SD % CV SD % CV SD % CV QC1 3.6 0.07 2.0 0.05 1.4 0.03 0.7 0.09 2.5 0.09 2.5 QC2 12.3 0.09 0.8 0.10 0.8 0.03 0.3 0.14 1.1 0.14 1.1 Calibrator 21.2 0.12 0.6 0.11 0.5 0.09 0.4 0.18 0.9 0.19 0.9 Serum 1 3.1 0.07 2.3 0.07 2.3 0.11 3.5 0.14 4.7 0.15 4.8 Serum 2 5.7 0.07 1.3 0.08 1.4 0.07 1.2 0.13 2.2 0.13 2.2 Serum 3 11.6 0.09 0.8 0.11 1.0 0.05 0.5 0.15 0.3 0.15 1.3 Serum 4 23.2 0.14 0.6 0.15 0.6 0.07 0.3 0.22 0.9 0.22 0.9 Serum 5 61.8 0.32 0.5 0.36 0.6 0.42 0.7 0.63 1.0 0.64 1.0 Serum 6 97.3 0.48 0.5 0.51 0.5 0.62 0.6 0.93 1.0 0.94 1.0 b. Linearity/assay reportable range: Linearity was evaluated using high and low 1,5-AG serum pools that were mixed to create the following eleven samples containing 1,5-AG concentrations spanning the measuring range: 0.2, 10.9, 22.1, 34.4, 45.3, 58.5, 68.6, 81.1, 92.7, 103.2, and 116.7 ug/mL 1,5-AG. Samples were measured in triplicate using one lot of reagent on a Beckman AU860 analyzer. The results of the linear regression analysis are summarized below: y = 1.0014x – 0.8351, R2 = 0.9998 The results of the linearity study support the claimed measuring range of 0.5 to 110 ug/mL. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability: The Diazyme 1,5-AG Assay is traceable to an internal standard manufactured using highly purified 1,5-AG, referred to as the Master Calibrator. The Master Calibrator was prepared by spiking the appropriate amount of pure 1,5-AG into a phosphate buffer solution. The Master Calibrator was subsequently value assigned. d. Detection limit: The Limit of Blank (LoB) study was performed with five serum samples, which were dialyzed to removed endogenous 1,5-AG, and two reagent lots. The samples were 5
tested in quadruplicate over three days (n=60 samples per reagent lot). The LoB was determined to be 0.3 ug/mL. The Limit of Detection (LoD) study was performed with five serum samples that were prepared by diluting native serum samples with serum that was dialyzed to removed endogenous 1,5-AG, with two reagent lots. Samples were tested in quadruplicate over three days (n=60 samples per reagent lot). The LoD was calculated as the LoB + (1.653 * SD of LoD samples). The LoD was determined to be 0.45 ug/mL. The Limit of Quantitation (LoQ) study was performed using five serum samples ranging from approximately 1 to 16 times the claimed LoB. Samples were either native serum or serum diluted with dialyzed serum to obtain the relevant 1
Applicant: |
idK180209_s0_e2000 | K180209.txt | proprietary and established names | Diazyme 1,5-AG Assay | ANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k180209 B. Purpose for Submission: New Device C. Measurand: 1,5-Anhydroglucitol (1,5-AG) D. Type of Test: Quantitative, colorometric, pyranose oxidase (PROD) E. Applicant: Diazyme Laboratories Inc. F. Proprietary and Established Names: Diazyme 1,5-AG Assay G. Regulatory Information: 1. Regulation section: 21 CFR 864.7470; Glycosylated hemoglobin assay 2. Classification: Class II 3. Product code: NOZ; Assay, 1,5-Anhydroglucitol 4. Panel: Hematology (81) 2
H. Intended Use: 1. Intended use(s): See indications for use below. 2. Indication(s) for use: Diazyme 1,5-anhydroglucitol (1,5-AG) Assay is an enzymatic method intended for the quantitative determination of 1,5-anhydroglucitol (1,5-AG) in serum or plasma. The 1,5-
AG Assay is for the intermediate term (preceding 1-2 weeks) monitoring of glycemic control in people with diabetes. For in vitro diagnostic use only. 3. Special conditions for use statement(s): · For in vitro diagnostic use only · Prescription use only 4. Special instrument requirements: Beckman AU680 I. Device Description: Diazyme’s 1,5-AG Assay is an enzymatic method consisting of a two-reagent test kit (Reagent 1 and Reagent 2) and is to be used with a fully automated chemistry analyzer. The test system also includes a calibration standard and a two-level control set, both of which are purchased separately. J. Substantial Equivalence Information: 1. Predicate device name(s): GlycoMark 2. Predicate 510(k) number(s): k031604 3. Comparison with predicate: Similarities/Differences Item Diazyme 1,5-AG Assay GlycoMark™ (K031604) Indications for use The intermediate term monitoring of glycemic Same 3
Similarities/Differences
Item Diazyme 1,5-AG Assay GlycoMark™ (K031604) control in people with diabetes Sample
Serum or plasma
Same Test principle Pyranose
oxidase (PROD)
Same Linearity
0.5-110 ug/mL
Same Methodology
Colorimetric
Same Instruments
Beckman AU680
Roche Hitachi 917
K. Standard/Guidance Document Referenced (if applicable):
Clinical and Laboratory Standards Institute EP5-
Clinical and Laboratory Standards Institute EP6-A – Evaluation of the Linearity of Quantitative Analytical Methods; Approved (2003) A2 –
Clinical and Laboratory Standards Institute EP7-A2 – Interference Testing in Clinical Chemistry; Approved Guideline (2002) Evaluation of Precision Performance Clinical and Laboratory Standards Institute EP17-A2: Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline of Clinical Chemistry Devices
Clinical and Laboratory Standards Institute C28-A3 – Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline, Third Edition -
L. Test Principle: Approved Guideline
Diazyme’s 1,5-AG assay uses the enzyme pyranose oxidase (PROD) to oxidize the 2nd position hydroxyl group of 1,5-AG and to detect the generated hydrogen peroxide by colorimetry using peroxidase (POD). To eliminate reactive glucose in sample, it is pretreated by enzymatic reactions using hexokinase and pyruvate kinase (PK). Hexokinase uses adenosine triphosphate (ATP) to convert glucose into non-reactive glucose-6-phosphate (G-
6-P), generating adenosine diphosphate (ADP). The reaction is driven to completion with PK, as ADP is phosphorylated to ATP during the conversion of phosphoenolpyruvate (PEP) into pyruvate. -
M. Performance Characteristics (if/when applicable): Second Edition
Analytical performance: 1.
2.
a. Precision/Reproducibility: 4
Precision studies were performed using six serum samples containing the following concentrations of 1,5-AG: 3.1, 5.7, 11.6, 23.2, 61.8 and 97.3 ug/mL. Two levels of quality control (QC) material (3.6 and 12.3 ug/mL) and one level of calibrator solution (21.1 ug/mL) were also tested. Samples were tested in duplicate using three reagent lots over 20 days with two runs per day (20x2x2 design). Samples were analyzed using the Diazyme 1,5-AG Assay run on a Beckman AU680 analyzer. The results of data analysis of the combined three lots (n=240) are summarized below: Sample Mean Within-run Between- Run Between-Day Between-Lot Total SD % CV SD % CV SD % CV SD % CV SD % CV QC1 3.6 0.07 2.0 0.05 1.4 0.03 0.7 0.09 2.5 0.09 2.5 QC2 12.3 0.09 0.8 0.10 0.8 0.03 0.3 0.14 1.1 0.14 1.1 Calibrator 21.2 0.12 0.6 0.11 0.5 0.09 0.4 0.18 0.9 0.19 0.9 Serum 1 3.1 0.07 2.3 0.07 2.3 0.11 3.5 0.14 4.7 0.15 4.8 Serum 2 5.7 0.07 1.3 0.08 1.4 0.07 1.2 0.13 2.2 0.13 2.2 Serum 3 11.6 0.09 0.8 0.11 1.0 0.05 0.5 0.15 0.3 0.15 1.3 Serum 4 23.2 0.14 0.6 0.15 0.6 0.07 0.3 0.22 0.9 0.22 0.9 Serum 5 61.8 0.32 0.5 0.36 0.6 0.42 0.7 0.63 1.0 0.64 1.0 Serum 6 97.3 0.48 0.5 0.51 0.5 0.62 0.6 0.93 1.0 0.94 1.0 b. Linearity/assay reportable range: Linearity was evaluated using high and low 1,5-AG serum pools that were mixed to create the following eleven samples containing 1,5-AG concentrations spanning the measuring range: 0.2, 10.9, 22.1, 34.4, 45.3, 58.5, 68.6, 81.1, 92.7, 103.2, and 116.7 ug/mL 1,5-AG. Samples were measured in triplicate using one lot of reagent on a Beckman AU860 analyzer. The results of the linear regression analysis are summarized below: y = 1.0014x – 0.8351, R2 = 0.9998 The results of the linearity study support the claimed measuring range of 0.5 to 110 ug/mL. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability: The Diazyme 1,5-AG Assay is traceable to an internal standard manufactured using highly purified 1,5-AG, referred to as the Master Calibrator. The Master Calibrator was prepared by spiking the appropriate amount of pure 1,5-AG into a phosphate buffer solution. The Master Calibrator was subsequently value assigned. d. Detection limit: The Limit of Blank (LoB) study was performed with five serum samples, which were dialyzed to removed endogenous 1,5-AG, and two reagent lots. The samples were 5
tested in quadruplicate over three days (n=60 samples per reagent lot). The LoB was determined to be 0.3 ug/mL. The Limit of Detection (LoD) study was performed with five serum samples that were prepared by diluting native serum samples with serum that was dialyzed to removed endogenous 1,5-AG, with two reagent lots. Samples were tested in quadruplicate over three days (n=60 samples per reagent lot). The LoD was calculated as the LoB + (1.653 * SD of LoD samples). The LoD was determined to be 0.45 ug/mL. The Limit of Quantitation (LoQ) study was performed using five serum samples ranging from approximately 1 to 16 times the claimed LoB. Samples were either native serum or serum diluted with dialyzed serum to obtain the relevant 1
Proprietary and established names: |
idK180209_s0_e2000 | K180209.txt | regulation section | 21 CFR 864.7470; Glycosylated hemoglobin assay | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k180209 B. Purpose for Submission: New Device C. Measurand: 1,5-Anhydroglucitol (1,5-AG) D. Type of Test: Quantitative, colorometric, pyranose oxidase (PROD) E. Applicant: Diazyme Laboratories Inc. F. Proprietary and Established Names: Diazyme 1,5-AG Assay G. Regulatory Information: 1. Regulation section: 21 CFR 864.7470; Glycosylated hemoglobin assay 2. Classification: Class II 3. Product code: NOZ; Assay, 1,5-Anhydroglucitol 4. Panel: Hematology (81) 2
H. Intended Use: 1. Intended use(s): See indications for use below. 2. Indication(s) for use: Diazyme 1,5-anhydroglucitol (1,5-AG) Assay is an enzymatic method intended for the quantitative determination of 1,5-anhydroglucitol (1,5-AG) in serum or plasma. The 1,5-
AG Assay is for the intermediate term (preceding 1-2 weeks) monitoring of glycemic control in people with diabetes. For in vitro diagnostic use only. 3. Special conditions for use statement(s): · For in vitro diagnostic use only · Prescription use only 4. Special instrument requirements: Beckman AU680 I. Device Description: Diazyme’s 1,5-AG Assay is an enzymatic method consisting of a two-reagent test kit (Reagent 1 and Reagent 2) and is to be used with a fully automated chemistry analyzer. The test system also includes a calibration standard and a two-level control set, both of which are purchased separately. J. Substantial Equivalence Information: 1. Predicate device name(s): GlycoMark 2. Predicate 510(k) number(s): k031604 3. Comparison with predicate: Similarities/Differences Item Diazyme 1,5-AG Assay GlycoMark™ (K031604) Indications for use The intermediate term monitoring of glycemic Same 3
Similarities/Differences
Item Diazyme 1,5-AG Assay GlycoMark™ (K031604) control in people with diabetes Sample
Serum or plasma
Same Test principle Pyranose
oxidase (PROD)
Same Linearity
0.5-110 ug/mL
Same Methodology
Colorimetric
Same Instruments
Beckman AU680
Roche Hitachi 917
K. Standard/Guidance Document Referenced (if applicable):
Clinical and Laboratory Standards Institute EP5-
Clinical and Laboratory Standards Institute EP6-A – Evaluation of the Linearity of Quantitative Analytical Methods; Approved (2003) A2 –
Clinical and Laboratory Standards Institute EP7-A2 – Interference Testing in Clinical Chemistry; Approved Guideline (2002) Evaluation of Precision Performance Clinical and Laboratory Standards Institute EP17-A2: Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline of Clinical Chemistry Devices
Clinical and Laboratory Standards Institute C28-A3 – Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline, Third Edition -
L. Test Principle: Approved Guideline
Diazyme’s 1,5-AG assay uses the enzyme pyranose oxidase (PROD) to oxidize the 2nd position hydroxyl group of 1,5-AG and to detect the generated hydrogen peroxide by colorimetry using peroxidase (POD). To eliminate reactive glucose in sample, it is pretreated by enzymatic reactions using hexokinase and pyruvate kinase (PK). Hexokinase uses adenosine triphosphate (ATP) to convert glucose into non-reactive glucose-6-phosphate (G-
6-P), generating adenosine diphosphate (ADP). The reaction is driven to completion with PK, as ADP is phosphorylated to ATP during the conversion of phosphoenolpyruvate (PEP) into pyruvate. -
M. Performance Characteristics (if/when applicable): Second Edition
Analytical performance: 1.
2.
a. Precision/Reproducibility: 4
Precision studies were performed using six serum samples containing the following concentrations of 1,5-AG: 3.1, 5.7, 11.6, 23.2, 61.8 and 97.3 ug/mL. Two levels of quality control (QC) material (3.6 and 12.3 ug/mL) and one level of calibrator solution (21.1 ug/mL) were also tested. Samples were tested in duplicate using three reagent lots over 20 days with two runs per day (20x2x2 design). Samples were analyzed using the Diazyme 1,5-AG Assay run on a Beckman AU680 analyzer. The results of data analysis of the combined three lots (n=240) are summarized below: Sample Mean Within-run Between- Run Between-Day Between-Lot Total SD % CV SD % CV SD % CV SD % CV SD % CV QC1 3.6 0.07 2.0 0.05 1.4 0.03 0.7 0.09 2.5 0.09 2.5 QC2 12.3 0.09 0.8 0.10 0.8 0.03 0.3 0.14 1.1 0.14 1.1 Calibrator 21.2 0.12 0.6 0.11 0.5 0.09 0.4 0.18 0.9 0.19 0.9 Serum 1 3.1 0.07 2.3 0.07 2.3 0.11 3.5 0.14 4.7 0.15 4.8 Serum 2 5.7 0.07 1.3 0.08 1.4 0.07 1.2 0.13 2.2 0.13 2.2 Serum 3 11.6 0.09 0.8 0.11 1.0 0.05 0.5 0.15 0.3 0.15 1.3 Serum 4 23.2 0.14 0.6 0.15 0.6 0.07 0.3 0.22 0.9 0.22 0.9 Serum 5 61.8 0.32 0.5 0.36 0.6 0.42 0.7 0.63 1.0 0.64 1.0 Serum 6 97.3 0.48 0.5 0.51 0.5 0.62 0.6 0.93 1.0 0.94 1.0 b. Linearity/assay reportable range: Linearity was evaluated using high and low 1,5-AG serum pools that were mixed to create the following eleven samples containing 1,5-AG concentrations spanning the measuring range: 0.2, 10.9, 22.1, 34.4, 45.3, 58.5, 68.6, 81.1, 92.7, 103.2, and 116.7 ug/mL 1,5-AG. Samples were measured in triplicate using one lot of reagent on a Beckman AU860 analyzer. The results of the linear regression analysis are summarized below: y = 1.0014x – 0.8351, R2 = 0.9998 The results of the linearity study support the claimed measuring range of 0.5 to 110 ug/mL. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability: The Diazyme 1,5-AG Assay is traceable to an internal standard manufactured using highly purified 1,5-AG, referred to as the Master Calibrator. The Master Calibrator was prepared by spiking the appropriate amount of pure 1,5-AG into a phosphate buffer solution. The Master Calibrator was subsequently value assigned. d. Detection limit: The Limit of Blank (LoB) study was performed with five serum samples, which were dialyzed to removed endogenous 1,5-AG, and two reagent lots. The samples were 5
tested in quadruplicate over three days (n=60 samples per reagent lot). The LoB was determined to be 0.3 ug/mL. The Limit of Detection (LoD) study was performed with five serum samples that were prepared by diluting native serum samples with serum that was dialyzed to removed endogenous 1,5-AG, with two reagent lots. Samples were tested in quadruplicate over three days (n=60 samples per reagent lot). The LoD was calculated as the LoB + (1.653 * SD of LoD samples). The LoD was determined to be 0.45 ug/mL. The Limit of Quantitation (LoQ) study was performed using five serum samples ranging from approximately 1 to 16 times the claimed LoB. Samples were either native serum or serum diluted with dialyzed serum to obtain the relevant 1
Regulation section: |
idK180209_s2000_e4000 | K180209.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 801 and 809, as applicable. | . The diluted serum samples were then tested in 8 replicates per day over 5 days using two lots of reagents. The sponsor defines LoQ as the lowest concentration which meets an imprecision (%CV) of <20%. The LoQ was determined to be 0.6 ug/mL. e. Analytical specificity: Interference studies were conducted with serum samples adjusted to three levels of 1,5-AG (approximately 5.0, 23.0, and 50 ug/mL). Each sample was divided into a test pool and a control pool, and potentially interfering substances were added to the test pool. Test pool samples with various concentrations of substances were compared to non-spiked controls. The sponsor defines significant interference as greater than ±10% bias between the test and control samples measured using the Diazyme 1,5-AG Assay on a Beckman AU680 analyzer. The following substances were tested up to the levels indicated and demonstrated no significant interference: Substance Highest concentration of substance tested that did not demonstrate significant interference (mg/dL) Bilirubin 5 Conjugated Bilirubin 5 Hemoglobin 125 Triglycerides 1000 Ascorbic Acid 37.5 Glucose 1000 Maltose 500 Uric Acid 20 Creatinine 10 Urea 20 Based on the testing completed, the sponsor has included the following limitation in the labeling: WARNING: Significant negative bias (>10%) was observed at bilirubin levels 6
> 5 mg/dL. This should be taken into consideration for patients with conditions that cause hyperbilirubinemia (Gilbert’s disease, Jaundice, etc.). f. Assay cut-off: Not applicable. 3. Comparison studies: a. Method comparison with predicate device: A method comparison study was conducted by comparing the results from the 1,5-
AG Assay to the to the predicate method (GlycoMark 1,5-AG, K031604) on a Beckman AU680 analyzer. Serum samples ranging in 1,5-AG concentration from 1.7 to 36.2 ug/mL were collected from 91 diabetic and non-diabetic subjects. In order to obtain sufficient samples in the high 1,5-AG concentration range, 11 additional samples were spiked to obtain concentrations between 39.0 and 103.7 ug/mL 1,5-AG. Samples were tested in singlet. The results of linear regression analysis are as follows: y = 1.0164x – 0.2042; R2 = 0.9995 b. Matrix comparison: To evaluate anticoagulant effects, paired serum/K2EDTA plasma and serum/Lithium Heparin plasma samples were tested on the Beckman AU680 analyzer with the Diazyme 1,5-AG Assay. Fifty-two serum vs. K2EDTA plasma and 52 serum vs. Lithium Heparin plasma paired sample sets were evaluated. The results of the linear regression analysis are presented below: Tube Type Regression R2 Test range ug/mL Lithium-heparin plasma vs serum y = 1.0059x + 0.0465 0.997 0.8 - 109 K2EDTA plasma vs serum y = 1.0071x – 0.6457 0.994 1.7 - 105.6 The study data supports the sponsor’s claim that the Diazyme 1,5-AG Assay is suitable for use with human specimens consisting of serum, K2EDTA plasma, and Lithium Heparin plasma. 4. Clinical studies: a. Clinical Sensitivity: Not applicable. 7
b. Clinical specificity: Not applicable. c.
Other clinical supportive data (when a. and b. are not applicable): Not applicable. 5. Clinical cut-off: Not applicable. 6. Expected values/Reference range: To establish the reference interval of 1,5-AG for a normal population, serum samples from 280 apparently healthy adults, 140 males and 140 females, were tested using the Diazyme 1,5-AG Assay on the Beckman AU680 analyzer. Using non-parametric 5th- 95th percentiles, the reference interval was established to be from 8.19 to 32.19 ug/mL for males and 6.00 to 29.10 ug/mL for females. N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 801 and 809, as applicable. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
Proposed labeling: |
idK180209_s2000_e4000 | K180209.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | AG concentrations. The diluted serum samples were then tested in 8 replicates per day over 5 days using two lots of reagents. The sponsor defines LoQ as the lowest concentration which meets an imprecision (%CV) of <20%. The LoQ was determined to be 0.6 ug/mL. e. Analytical specificity: Interference studies were conducted with serum samples adjusted to three levels of 1,5-AG (approximately 5.0, 23.0, and 50 ug/mL). Each sample was divided into a test pool and a control pool, and potentially interfering substances were added to the test pool. Test pool samples with various concentrations of substances were compared to non-spiked controls. The sponsor defines significant interference as greater than ±10% bias between the test and control samples measured using the Diazyme 1,5-AG Assay on a Beckman AU680 analyzer. The following substances were tested up to the levels indicated and demonstrated no significant interference: Substance Highest concentration of substance tested that did not demonstrate significant interference (mg/dL) Bilirubin 5 Conjugated Bilirubin 5 Hemoglobin 125 Triglycerides 1000 Ascorbic Acid 37.5 Glucose 1000 Maltose 500 Uric Acid 20 Creatinine 10 Urea 20 Based on the testing completed, the sponsor has included the following limitation in the labeling: WARNING: Significant negative bias (>10%) was observed at bilirubin levels 6
> 5 mg/dL. This should be taken into consideration for patients with conditions that cause hyperbilirubinemia (Gilbert’s disease, Jaundice, etc.). f. Assay cut-off: Not applicable. 3. Comparison studies: a. Method comparison with predicate device: A method comparison study was conducted by comparing the results from the 1,5-
AG Assay to the to the predicate method (GlycoMark 1,5-AG, K031604) on a Beckman AU680 analyzer. Serum samples ranging in 1,5-AG concentration from 1.7 to 36.2 ug/mL were collected from 91 diabetic and non-diabetic subjects. In order to obtain sufficient samples in the high 1,5-AG concentration range, 11 additional samples were spiked to obtain concentrations between 39.0 and 103.7 ug/mL 1,5-AG. Samples were tested in singlet. The results of linear regression analysis are as follows: y = 1.0164x – 0.2042; R2 = 0.9995 b. Matrix comparison: To evaluate anticoagulant effects, paired serum/K2EDTA plasma and serum/Lithium Heparin plasma samples were tested on the Beckman AU680 analyzer with the Diazyme 1,5-AG Assay. Fifty-two serum vs. K2EDTA plasma and 52 serum vs. Lithium Heparin plasma paired sample sets were evaluated. The results of the linear regression analysis are presented below: Tube Type Regression R2 Test range ug/mL Lithium-heparin plasma vs serum y = 1.0059x + 0.0465 0.997 0.8 - 109 K2EDTA plasma vs serum y = 1.0071x – 0.6457 0.994 1.7 - 105.6 The study data supports the sponsor’s claim that the Diazyme 1,5-AG Assay is suitable for use with human specimens consisting of serum, K2EDTA plasma, and Lithium Heparin plasma. 4. Clinical studies: a. Clinical Sensitivity: Not applicable. 7
b. Clinical specificity: Not applicable. c.
Other clinical supportive data (when a. and b. are not applicable): Not applicable. 5. Clinical cut-off: Not applicable. 6. Expected values/Reference range: To establish the reference interval of 1,5-AG for a normal population, serum samples from 280 apparently healthy adults, 140 males and 140 females, were tested using the Diazyme 1,5-AG Assay on the Beckman AU680 analyzer. Using non-parametric 5th- 95th percentiles, the reference interval was established to be from 8.19 to 32.19 ug/mL for males and 6.00 to 29.10 ug/mL for females. N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 801 and 809, as applicable. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
Conclusion: |
idK190223_s0_e2000 | K190223.txt | purpose for submission | To obtain a substantial equivalence determination for the Cepheid Xpert CT/NG Control Panel for use with the Cepheid Xpert CT/NG Assay on the GeneXpert Instrument System. | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K190223 B. Purpose for Submission: To obtain a substantial equivalence determination for the Cepheid Xpert CT/NG Control Panel for use with the Cepheid Xpert CT/NG Assay on the GeneXpert Instrument System. C. Measurand: Nucleic acids from inactivated Chlamydia trachomatis and Neisseria gonorrhoeae (positive control) and from human epithelial cells (negative control). D. Type of Test: The Cepheid Xpert CT/NG Control Panel is an external assayed quality control material (positive and negative) designed to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae in genitourinary specimens when used with the Cepheid Xpert CT/NG assay on the Cepheid Xpert Instrument System. E. Applicant: Microbiologics, Inc. F. Proprietary and Established Names: Trade Name: Cepheid Xpert CT/NG Control Panel G. Regulatory Information: 1. Regulation section: 21 CFR 866.3920, Assayed quality control material for clinical microbiology assays 2. Classification: Class II (Special Controls) 3. Product code: 2 PMN Assayed external control material for microbiology nucleic acid amplification assays 4. Panel: (83) Microbiology H. Intended Use: 1. Intended use: The Cepheid Xpert CT/NG Control Panel is intended for use as an external assayed positive and negative quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) performed with the Cepheid Xpert CT/NG assay on the GeneXpert Instrument System. The controls consist of cultured and inactivated Chlamydia trachomatis and Neisseria gonorrhoeae as the positive control and human cells as the negative control. The Cepheid Xpert CT/NG Control Panel is not intended to replace manufacturer controls provided with the device. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For in vitro diagnostic use only. For prescription use only. 3. Special instrument requirements: Cepheid Xpert Instrument System I. Device Description: The Cepheid Xpert CT/NG Control Panel is a quality control material provided to the customer as six individually packaged positive and negative swabs. Each positive swab consists of inactivated Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) microorganisms. Each negative swab consists of human epithelial cells. The positive swabs were prepared with cultured, inactivated and quantified stocks of CT and NG. The negative swabs were prepared from human cells derived from a cultured cell line, certified for sterility, and quantified in cells/mL. 3 J. Substantial Equivalence Information: 1. Predicate device name(s): Cepheid Xpert GBS LB Control Panel 2. Predicate 510(k) number(s): K182472 3. Comparison with predicate: K190223 K182472 (Predicate) Device Trade Name Cepheid Xpert CT/NG Control Panel Cepheid Xpert GBS LB Control Panel Similarities Intended Use The Cepheid Xpert CT/NG Control Panel is intended for use as an external assayed positive and negative quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) performed with the Cepheid Xpert CT/NG assay on the GeneXpert Instrument System. The controls consist of cultured and inactivated Chlamydia trachomatis and Neisseria gonorrhoeae as the positive control and human cells as the negative control. The Cepheid Xpert CT/NG Control Panel is not intended to replace manufacturer controls provided with the device. External assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Group B Streptococcus (GBS) performed with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. The controls comprise cultured and inactivated Streptococcus agalactiae as the positive control and Lactobacillus acidophilus as the negative control. The Cepheid Xpert GBS LB Control Panel is not intended to replace the manufacturer controls provided with the device. Physical Format Swabs Swabs Composition Inactivated microorganisms Inactivated microorganisms Test System Cepheid GeneXpert System Cepheid GeneXpert System Directions for Use Process like patient sample Process like patient sample Assay Steps Monitored Extraction, amplification, and detection Extraction, amplification, and detection Number of Targets Monitored in One Assay Multiple Multiple 4 Differences Assay Compatibility Cepheid Xpert CT/NG Assay Cepheid Xpert GBS LB Assay Positive Control Chlamydia trachomatis Neisseria gonorrhoeae Streptococcus agalactiae Negative Control Human epithelial cells Lactobacillus acidophilus K. Standard/Guidance Document Referenced (if applicable): Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline. CLSI Document EP25-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2009. Evaluation of Precision of Quantitative Measurement Methods: Approved Guideline. CLSI Document EP05-A3, 2014. L. Test Principle: Not applicable; this is control material to monitor performance of an in vitro diagnostic test. The test principle defaults to the Cepheid Xpert CT/NG assay, K121710. M. Performance Characteristics: 1. Analytical performance: a. Reproducibility: The Cepheid Xpert CT/NG Control Panel was evaluated at three testing sites with two operators at each site (total of six operators). Three lots of the control material were tested with the Cepheid Xpert CT/NG assay on the Cepheid Xpert Instrument, over five days. Each positive and negative control was tested in three replicates on each day. There were seven ERROR results (assay aborted due to instrument or reagent problem) and one INVALID result (failure of the internal control/s). Those samples were retested using a new control swab according to the Instructions for Use. All testing utilized the Xpert Vaginal/Endocervical Swab Specimen Collection kit. The Cepheid Xpert CT/NG Assay detects one target for CT) and two different targets for NG (NG2 and NG4). Both NG targets need to be positive for the Xpert CT/NG Assay to return a positive NG result. The qualitative results from the reproducibility study are summarized below. 5 Positive Control Target % Agreement with Expected Results, by Test Site Site 1 1,3 Site 22,3 Site 3 Overall C. trachomatis 31/31 (100%) 31/31 (100%) 30/30 (100%) 92/92 (100%) N. gonorrhoeae (NG2) 31/31 (100%) 31/31 (100%) 30/30 (100%) 92/92 (100%) N. gonorrhoeae (NG4) 31/31 (100%) 31/31 (100%) 30/30 (100%) 92/92 (100%) SPC 31/31 (100%) 31/31 (100%) 30/30 (100%) 92/92 (100%) SPC: Sample Processing Control 1Three ERROR results were observed; in all cases a new control was retested and the expected results were obtained. 2Two ERROR results and one INVALID result were obtained; in all cases a new control was retested and the expected results were obtained. 3 More than 30 measurements were taken as extra positive controls were ran during re-tests of negative controls. Negative Control Target % Agreement with Expected Results, by Test Site Site 11,2,3* Site 21,2,3 Site 3 Overall SAC 33/33 (100%) 34/34 (100%) 30/30 (100%) 97/97 (100%) SPC 33/33 (100%) 34/34 (100%) 30/30 (100%) 97/97 (100%) SAC: Sample Adequacy Control; SPC: Sample Processing Control 1Two ERROR results were observed; in all cases a new control was retested and the expected results were obtained. 2One Negative Control at site 1 and two Negative Control at Site 2 generated a positive result for NG2 target, however, the qualitative results were negative in each case because the Xpert CT/NG Assay requires both NG2 and NG4 targets to be positive in order to return a positive result for NG. In accordance with the assay protocol, the work area was cleaned and the controls were retested. 3More than 30 measurements were taken as extra positive controls were ran during re-tests of negative controls. The calculated average Ct score values and the associated standard deviation (SD) and percent coefficient of variation (% CV) across the three testing sites obtained in the reproducibility study are shown below. Positive Control Target N Mean (Ct) SD %CV C.
Purpose for submission: |
idK190223_s0_e2000 | K190223.txt | measurand | Nucleic acids from inactivated Chlamydia trachomatis and Neisseria gonorrhoeae (positive control) and from human epithelial cells (negative control). | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K190223 B. Purpose for Submission: To obtain a substantial equivalence determination for the Cepheid Xpert CT/NG Control Panel for use with the Cepheid Xpert CT/NG Assay on the GeneXpert Instrument System. C. Measurand: Nucleic acids from inactivated Chlamydia trachomatis and Neisseria gonorrhoeae (positive control) and from human epithelial cells (negative control). D. Type of Test: The Cepheid Xpert CT/NG Control Panel is an external assayed quality control material (positive and negative) designed to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae in genitourinary specimens when used with the Cepheid Xpert CT/NG assay on the Cepheid Xpert Instrument System. E. Applicant: Microbiologics, Inc. F. Proprietary and Established Names: Trade Name: Cepheid Xpert CT/NG Control Panel G. Regulatory Information: 1. Regulation section: 21 CFR 866.3920, Assayed quality control material for clinical microbiology assays 2. Classification: Class II (Special Controls) 3. Product code: 2 PMN Assayed external control material for microbiology nucleic acid amplification assays 4. Panel: (83) Microbiology H. Intended Use: 1. Intended use: The Cepheid Xpert CT/NG Control Panel is intended for use as an external assayed positive and negative quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) performed with the Cepheid Xpert CT/NG assay on the GeneXpert Instrument System. The controls consist of cultured and inactivated Chlamydia trachomatis and Neisseria gonorrhoeae as the positive control and human cells as the negative control. The Cepheid Xpert CT/NG Control Panel is not intended to replace manufacturer controls provided with the device. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For in vitro diagnostic use only. For prescription use only. 3. Special instrument requirements: Cepheid Xpert Instrument System I. Device Description: The Cepheid Xpert CT/NG Control Panel is a quality control material provided to the customer as six individually packaged positive and negative swabs. Each positive swab consists of inactivated Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) microorganisms. Each negative swab consists of human epithelial cells. The positive swabs were prepared with cultured, inactivated and quantified stocks of CT and NG. The negative swabs were prepared from human cells derived from a cultured cell line, certified for sterility, and quantified in cells/mL. 3 J. Substantial Equivalence Information: 1. Predicate device name(s): Cepheid Xpert GBS LB Control Panel 2. Predicate 510(k) number(s): K182472 3. Comparison with predicate: K190223 K182472 (Predicate) Device Trade Name Cepheid Xpert CT/NG Control Panel Cepheid Xpert GBS LB Control Panel Similarities Intended Use The Cepheid Xpert CT/NG Control Panel is intended for use as an external assayed positive and negative quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) performed with the Cepheid Xpert CT/NG assay on the GeneXpert Instrument System. The controls consist of cultured and inactivated Chlamydia trachomatis and Neisseria gonorrhoeae as the positive control and human cells as the negative control. The Cepheid Xpert CT/NG Control Panel is not intended to replace manufacturer controls provided with the device. External assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Group B Streptococcus (GBS) performed with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. The controls comprise cultured and inactivated Streptococcus agalactiae as the positive control and Lactobacillus acidophilus as the negative control. The Cepheid Xpert GBS LB Control Panel is not intended to replace the manufacturer controls provided with the device. Physical Format Swabs Swabs Composition Inactivated microorganisms Inactivated microorganisms Test System Cepheid GeneXpert System Cepheid GeneXpert System Directions for Use Process like patient sample Process like patient sample Assay Steps Monitored Extraction, amplification, and detection Extraction, amplification, and detection Number of Targets Monitored in One Assay Multiple Multiple 4 Differences Assay Compatibility Cepheid Xpert CT/NG Assay Cepheid Xpert GBS LB Assay Positive Control Chlamydia trachomatis Neisseria gonorrhoeae Streptococcus agalactiae Negative Control Human epithelial cells Lactobacillus acidophilus K. Standard/Guidance Document Referenced (if applicable): Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline. CLSI Document EP25-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2009. Evaluation of Precision of Quantitative Measurement Methods: Approved Guideline. CLSI Document EP05-A3, 2014. L. Test Principle: Not applicable; this is control material to monitor performance of an in vitro diagnostic test. The test principle defaults to the Cepheid Xpert CT/NG assay, K121710. M. Performance Characteristics: 1. Analytical performance: a. Reproducibility: The Cepheid Xpert CT/NG Control Panel was evaluated at three testing sites with two operators at each site (total of six operators). Three lots of the control material were tested with the Cepheid Xpert CT/NG assay on the Cepheid Xpert Instrument, over five days. Each positive and negative control was tested in three replicates on each day. There were seven ERROR results (assay aborted due to instrument or reagent problem) and one INVALID result (failure of the internal control/s). Those samples were retested using a new control swab according to the Instructions for Use. All testing utilized the Xpert Vaginal/Endocervical Swab Specimen Collection kit. The Cepheid Xpert CT/NG Assay detects one target for CT) and two different targets for NG (NG2 and NG4). Both NG targets need to be positive for the Xpert CT/NG Assay to return a positive NG result. The qualitative results from the reproducibility study are summarized below. 5 Positive Control Target % Agreement with Expected Results, by Test Site Site 1 1,3 Site 22,3 Site 3 Overall C. trachomatis 31/31 (100%) 31/31 (100%) 30/30 (100%) 92/92 (100%) N. gonorrhoeae (NG2) 31/31 (100%) 31/31 (100%) 30/30 (100%) 92/92 (100%) N. gonorrhoeae (NG4) 31/31 (100%) 31/31 (100%) 30/30 (100%) 92/92 (100%) SPC 31/31 (100%) 31/31 (100%) 30/30 (100%) 92/92 (100%) SPC: Sample Processing Control 1Three ERROR results were observed; in all cases a new control was retested and the expected results were obtained. 2Two ERROR results and one INVALID result were obtained; in all cases a new control was retested and the expected results were obtained. 3 More than 30 measurements were taken as extra positive controls were ran during re-tests of negative controls. Negative Control Target % Agreement with Expected Results, by Test Site Site 11,2,3* Site 21,2,3 Site 3 Overall SAC 33/33 (100%) 34/34 (100%) 30/30 (100%) 97/97 (100%) SPC 33/33 (100%) 34/34 (100%) 30/30 (100%) 97/97 (100%) SAC: Sample Adequacy Control; SPC: Sample Processing Control 1Two ERROR results were observed; in all cases a new control was retested and the expected results were obtained. 2One Negative Control at site 1 and two Negative Control at Site 2 generated a positive result for NG2 target, however, the qualitative results were negative in each case because the Xpert CT/NG Assay requires both NG2 and NG4 targets to be positive in order to return a positive result for NG. In accordance with the assay protocol, the work area was cleaned and the controls were retested. 3More than 30 measurements were taken as extra positive controls were ran during re-tests of negative controls. The calculated average Ct score values and the associated standard deviation (SD) and percent coefficient of variation (% CV) across the three testing sites obtained in the reproducibility study are shown below. Positive Control Target N Mean (Ct) SD %CV C.
Measurand: |
idK190223_s0_e2000 | K190223.txt | type of test | The Cepheid Xpert CT/NG Control Panel is an external assayed quality control material (positive and negative) designed to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae in genitourinary specimens when used with the Cepheid Xpert CT/NG assay on the Cepheid Xpert Instrument System. | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K190223 B. Purpose for Submission: To obtain a substantial equivalence determination for the Cepheid Xpert CT/NG Control Panel for use with the Cepheid Xpert CT/NG Assay on the GeneXpert Instrument System. C. Measurand: Nucleic acids from inactivated Chlamydia trachomatis and Neisseria gonorrhoeae (positive control) and from human epithelial cells (negative control). D. Type of Test: The Cepheid Xpert CT/NG Control Panel is an external assayed quality control material (positive and negative) designed to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae in genitourinary specimens when used with the Cepheid Xpert CT/NG assay on the Cepheid Xpert Instrument System. E. Applicant: Microbiologics, Inc. F. Proprietary and Established Names: Trade Name: Cepheid Xpert CT/NG Control Panel G. Regulatory Information: 1. Regulation section: 21 CFR 866.3920, Assayed quality control material for clinical microbiology assays 2. Classification: Class II (Special Controls) 3. Product code: 2 PMN Assayed external control material for microbiology nucleic acid amplification assays 4. Panel: (83) Microbiology H. Intended Use: 1. Intended use: The Cepheid Xpert CT/NG Control Panel is intended for use as an external assayed positive and negative quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) performed with the Cepheid Xpert CT/NG assay on the GeneXpert Instrument System. The controls consist of cultured and inactivated Chlamydia trachomatis and Neisseria gonorrhoeae as the positive control and human cells as the negative control. The Cepheid Xpert CT/NG Control Panel is not intended to replace manufacturer controls provided with the device. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For in vitro diagnostic use only. For prescription use only. 3. Special instrument requirements: Cepheid Xpert Instrument System I. Device Description: The Cepheid Xpert CT/NG Control Panel is a quality control material provided to the customer as six individually packaged positive and negative swabs. Each positive swab consists of inactivated Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) microorganisms. Each negative swab consists of human epithelial cells. The positive swabs were prepared with cultured, inactivated and quantified stocks of CT and NG. The negative swabs were prepared from human cells derived from a cultured cell line, certified for sterility, and quantified in cells/mL. 3 J. Substantial Equivalence Information: 1. Predicate device name(s): Cepheid Xpert GBS LB Control Panel 2. Predicate 510(k) number(s): K182472 3. Comparison with predicate: K190223 K182472 (Predicate) Device Trade Name Cepheid Xpert CT/NG Control Panel Cepheid Xpert GBS LB Control Panel Similarities Intended Use The Cepheid Xpert CT/NG Control Panel is intended for use as an external assayed positive and negative quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) performed with the Cepheid Xpert CT/NG assay on the GeneXpert Instrument System. The controls consist of cultured and inactivated Chlamydia trachomatis and Neisseria gonorrhoeae as the positive control and human cells as the negative control. The Cepheid Xpert CT/NG Control Panel is not intended to replace manufacturer controls provided with the device. External assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Group B Streptococcus (GBS) performed with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. The controls comprise cultured and inactivated Streptococcus agalactiae as the positive control and Lactobacillus acidophilus as the negative control. The Cepheid Xpert GBS LB Control Panel is not intended to replace the manufacturer controls provided with the device. Physical Format Swabs Swabs Composition Inactivated microorganisms Inactivated microorganisms Test System Cepheid GeneXpert System Cepheid GeneXpert System Directions for Use Process like patient sample Process like patient sample Assay Steps Monitored Extraction, amplification, and detection Extraction, amplification, and detection Number of Targets Monitored in One Assay Multiple Multiple 4 Differences Assay Compatibility Cepheid Xpert CT/NG Assay Cepheid Xpert GBS LB Assay Positive Control Chlamydia trachomatis Neisseria gonorrhoeae Streptococcus agalactiae Negative Control Human epithelial cells Lactobacillus acidophilus K. Standard/Guidance Document Referenced (if applicable): Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline. CLSI Document EP25-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2009. Evaluation of Precision of Quantitative Measurement Methods: Approved Guideline. CLSI Document EP05-A3, 2014. L. Test Principle: Not applicable; this is control material to monitor performance of an in vitro diagnostic test. The test principle defaults to the Cepheid Xpert CT/NG assay, K121710. M. Performance Characteristics: 1. Analytical performance: a. Reproducibility: The Cepheid Xpert CT/NG Control Panel was evaluated at three testing sites with two operators at each site (total of six operators). Three lots of the control material were tested with the Cepheid Xpert CT/NG assay on the Cepheid Xpert Instrument, over five days. Each positive and negative control was tested in three replicates on each day. There were seven ERROR results (assay aborted due to instrument or reagent problem) and one INVALID result (failure of the internal control/s). Those samples were retested using a new control swab according to the Instructions for Use. All testing utilized the Xpert Vaginal/Endocervical Swab Specimen Collection kit. The Cepheid Xpert CT/NG Assay detects one target for CT) and two different targets for NG (NG2 and NG4). Both NG targets need to be positive for the Xpert CT/NG Assay to return a positive NG result. The qualitative results from the reproducibility study are summarized below. 5 Positive Control Target % Agreement with Expected Results, by Test Site Site 1 1,3 Site 22,3 Site 3 Overall C. trachomatis 31/31 (100%) 31/31 (100%) 30/30 (100%) 92/92 (100%) N. gonorrhoeae (NG2) 31/31 (100%) 31/31 (100%) 30/30 (100%) 92/92 (100%) N. gonorrhoeae (NG4) 31/31 (100%) 31/31 (100%) 30/30 (100%) 92/92 (100%) SPC 31/31 (100%) 31/31 (100%) 30/30 (100%) 92/92 (100%) SPC: Sample Processing Control 1Three ERROR results were observed; in all cases a new control was retested and the expected results were obtained. 2Two ERROR results and one INVALID result were obtained; in all cases a new control was retested and the expected results were obtained. 3 More than 30 measurements were taken as extra positive controls were ran during re-tests of negative controls. Negative Control Target % Agreement with Expected Results, by Test Site Site 11,2,3* Site 21,2,3 Site 3 Overall SAC 33/33 (100%) 34/34 (100%) 30/30 (100%) 97/97 (100%) SPC 33/33 (100%) 34/34 (100%) 30/30 (100%) 97/97 (100%) SAC: Sample Adequacy Control; SPC: Sample Processing Control 1Two ERROR results were observed; in all cases a new control was retested and the expected results were obtained. 2One Negative Control at site 1 and two Negative Control at Site 2 generated a positive result for NG2 target, however, the qualitative results were negative in each case because the Xpert CT/NG Assay requires both NG2 and NG4 targets to be positive in order to return a positive result for NG. In accordance with the assay protocol, the work area was cleaned and the controls were retested. 3More than 30 measurements were taken as extra positive controls were ran during re-tests of negative controls. The calculated average Ct score values and the associated standard deviation (SD) and percent coefficient of variation (% CV) across the three testing sites obtained in the reproducibility study are shown below. Positive Control Target N Mean (Ct) SD %CV C.
Type of test: |
idK190223_s0_e2000 | K190223.txt | classification | Class II | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K190223 B. Purpose for Submission: To obtain a substantial equivalence determination for the Cepheid Xpert CT/NG Control Panel for use with the Cepheid Xpert CT/NG Assay on the GeneXpert Instrument System. C. Measurand: Nucleic acids from inactivated Chlamydia trachomatis and Neisseria gonorrhoeae (positive control) and from human epithelial cells (negative control). D. Type of Test: The Cepheid Xpert CT/NG Control Panel is an external assayed quality control material (positive and negative) designed to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae in genitourinary specimens when used with the Cepheid Xpert CT/NG assay on the Cepheid Xpert Instrument System. E. Applicant: Microbiologics, Inc. F. Proprietary and Established Names: Trade Name: Cepheid Xpert CT/NG Control Panel G. Regulatory Information: 1. Regulation section: 21 CFR 866.3920, Assayed quality control material for clinical microbiology assays 2. Classification: Class II (Special Controls) 3. Product code: 2 PMN Assayed external control material for microbiology nucleic acid amplification assays 4. Panel: (83) Microbiology H. Intended Use: 1. Intended use: The Cepheid Xpert CT/NG Control Panel is intended for use as an external assayed positive and negative quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) performed with the Cepheid Xpert CT/NG assay on the GeneXpert Instrument System. The controls consist of cultured and inactivated Chlamydia trachomatis and Neisseria gonorrhoeae as the positive control and human cells as the negative control. The Cepheid Xpert CT/NG Control Panel is not intended to replace manufacturer controls provided with the device. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For in vitro diagnostic use only. For prescription use only. 3. Special instrument requirements: Cepheid Xpert Instrument System I. Device Description: The Cepheid Xpert CT/NG Control Panel is a quality control material provided to the customer as six individually packaged positive and negative swabs. Each positive swab consists of inactivated Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) microorganisms. Each negative swab consists of human epithelial cells. The positive swabs were prepared with cultured, inactivated and quantified stocks of CT and NG. The negative swabs were prepared from human cells derived from a cultured cell line, certified for sterility, and quantified in cells/mL. 3 J. Substantial Equivalence Information: 1. Predicate device name(s): Cepheid Xpert GBS LB Control Panel 2. Predicate 510(k) number(s): K182472 3. Comparison with predicate: K190223 K182472 (Predicate) Device Trade Name Cepheid Xpert CT/NG Control Panel Cepheid Xpert GBS LB Control Panel Similarities Intended Use The Cepheid Xpert CT/NG Control Panel is intended for use as an external assayed positive and negative quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) performed with the Cepheid Xpert CT/NG assay on the GeneXpert Instrument System. The controls consist of cultured and inactivated Chlamydia trachomatis and Neisseria gonorrhoeae as the positive control and human cells as the negative control. The Cepheid Xpert CT/NG Control Panel is not intended to replace manufacturer controls provided with the device. External assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Group B Streptococcus (GBS) performed with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. The controls comprise cultured and inactivated Streptococcus agalactiae as the positive control and Lactobacillus acidophilus as the negative control. The Cepheid Xpert GBS LB Control Panel is not intended to replace the manufacturer controls provided with the device. Physical Format Swabs Swabs Composition Inactivated microorganisms Inactivated microorganisms Test System Cepheid GeneXpert System Cepheid GeneXpert System Directions for Use Process like patient sample Process like patient sample Assay Steps Monitored Extraction, amplification, and detection Extraction, amplification, and detection Number of Targets Monitored in One Assay Multiple Multiple 4 Differences Assay Compatibility Cepheid Xpert CT/NG Assay Cepheid Xpert GBS LB Assay Positive Control Chlamydia trachomatis Neisseria gonorrhoeae Streptococcus agalactiae Negative Control Human epithelial cells Lactobacillus acidophilus K. Standard/Guidance Document Referenced (if applicable): Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline. CLSI Document EP25-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2009. Evaluation of Precision of Quantitative Measurement Methods: Approved Guideline. CLSI Document EP05-A3, 2014. L. Test Principle: Not applicable; this is control material to monitor performance of an in vitro diagnostic test. The test principle defaults to the Cepheid Xpert CT/NG assay, K121710. M. Performance Characteristics: 1. Analytical performance: a. Reproducibility: The Cepheid Xpert CT/NG Control Panel was evaluated at three testing sites with two operators at each site (total of six operators). Three lots of the control material were tested with the Cepheid Xpert CT/NG assay on the Cepheid Xpert Instrument, over five days. Each positive and negative control was tested in three replicates on each day. There were seven ERROR results (assay aborted due to instrument or reagent problem) and one INVALID result (failure of the internal control/s). Those samples were retested using a new control swab according to the Instructions for Use. All testing utilized the Xpert Vaginal/Endocervical Swab Specimen Collection kit. The Cepheid Xpert CT/NG Assay detects one target for CT) and two different targets for NG (NG2 and NG4). Both NG targets need to be positive for the Xpert CT/NG Assay to return a positive NG result. The qualitative results from the reproducibility study are summarized below. 5 Positive Control Target % Agreement with Expected Results, by Test Site Site 1 1,3 Site 22,3 Site 3 Overall C. trachomatis 31/31 (100%) 31/31 (100%) 30/30 (100%) 92/92 (100%) N. gonorrhoeae (NG2) 31/31 (100%) 31/31 (100%) 30/30 (100%) 92/92 (100%) N. gonorrhoeae (NG4) 31/31 (100%) 31/31 (100%) 30/30 (100%) 92/92 (100%) SPC 31/31 (100%) 31/31 (100%) 30/30 (100%) 92/92 (100%) SPC: Sample Processing Control 1Three ERROR results were observed; in all cases a new control was retested and the expected results were obtained. 2Two ERROR results and one INVALID result were obtained; in all cases a new control was retested and the expected results were obtained. 3 More than 30 measurements were taken as extra positive controls were ran during re-tests of negative controls. Negative Control Target % Agreement with Expected Results, by Test Site Site 11,2,3* Site 21,2,3 Site 3 Overall SAC 33/33 (100%) 34/34 (100%) 30/30 (100%) 97/97 (100%) SPC 33/33 (100%) 34/34 (100%) 30/30 (100%) 97/97 (100%) SAC: Sample Adequacy Control; SPC: Sample Processing Control 1Two ERROR results were observed; in all cases a new control was retested and the expected results were obtained. 2One Negative Control at site 1 and two Negative Control at Site 2 generated a positive result for NG2 target, however, the qualitative results were negative in each case because the Xpert CT/NG Assay requires both NG2 and NG4 targets to be positive in order to return a positive result for NG. In accordance with the assay protocol, the work area was cleaned and the controls were retested. 3More than 30 measurements were taken as extra positive controls were ran during re-tests of negative controls. The calculated average Ct score values and the associated standard deviation (SD) and percent coefficient of variation (% CV) across the three testing sites obtained in the reproducibility study are shown below. Positive Control Target N Mean (Ct) SD %CV C.
Classification: |
idK190223_s0_e2000 | K190223.txt | panel | (83) Microbiology | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K190223 B. Purpose for Submission: To obtain a substantial equivalence determination for the Cepheid Xpert CT/NG Control Panel for use with the Cepheid Xpert CT/NG Assay on the GeneXpert Instrument System. C. Measurand: Nucleic acids from inactivated Chlamydia trachomatis and Neisseria gonorrhoeae (positive control) and from human epithelial cells (negative control). D. Type of Test: The Cepheid Xpert CT/NG Control Panel is an external assayed quality control material (positive and negative) designed to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae in genitourinary specimens when used with the Cepheid Xpert CT/NG assay on the Cepheid Xpert Instrument System. E. Applicant: Microbiologics, Inc. F. Proprietary and Established Names: Trade Name: Cepheid Xpert CT/NG Control Panel G. Regulatory Information: 1. Regulation section: 21 CFR 866.3920, Assayed quality control material for clinical microbiology assays 2. Classification: Class II (Special Controls) 3. Product code: 2 PMN Assayed external control material for microbiology nucleic acid amplification assays 4. Panel: (83) Microbiology H. Intended Use: 1. Intended use: The Cepheid Xpert CT/NG Control Panel is intended for use as an external assayed positive and negative quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) performed with the Cepheid Xpert CT/NG assay on the GeneXpert Instrument System. The controls consist of cultured and inactivated Chlamydia trachomatis and Neisseria gonorrhoeae as the positive control and human cells as the negative control. The Cepheid Xpert CT/NG Control Panel is not intended to replace manufacturer controls provided with the device. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For in vitro diagnostic use only. For prescription use only. 3. Special instrument requirements: Cepheid Xpert Instrument System I. Device Description: The Cepheid Xpert CT/NG Control Panel is a quality control material provided to the customer as six individually packaged positive and negative swabs. Each positive swab consists of inactivated Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) microorganisms. Each negative swab consists of human epithelial cells. The positive swabs were prepared with cultured, inactivated and quantified stocks of CT and NG. The negative swabs were prepared from human cells derived from a cultured cell line, certified for sterility, and quantified in cells/mL. 3 J. Substantial Equivalence Information: 1. Predicate device name(s): Cepheid Xpert GBS LB Control Panel 2. Predicate 510(k) number(s): K182472 3. Comparison with predicate: K190223 K182472 (Predicate) Device Trade Name Cepheid Xpert CT/NG Control Panel Cepheid Xpert GBS LB Control Panel Similarities Intended Use The Cepheid Xpert CT/NG Control Panel is intended for use as an external assayed positive and negative quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) performed with the Cepheid Xpert CT/NG assay on the GeneXpert Instrument System. The controls consist of cultured and inactivated Chlamydia trachomatis and Neisseria gonorrhoeae as the positive control and human cells as the negative control. The Cepheid Xpert CT/NG Control Panel is not intended to replace manufacturer controls provided with the device. External assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Group B Streptococcus (GBS) performed with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. The controls comprise cultured and inactivated Streptococcus agalactiae as the positive control and Lactobacillus acidophilus as the negative control. The Cepheid Xpert GBS LB Control Panel is not intended to replace the manufacturer controls provided with the device. Physical Format Swabs Swabs Composition Inactivated microorganisms Inactivated microorganisms Test System Cepheid GeneXpert System Cepheid GeneXpert System Directions for Use Process like patient sample Process like patient sample Assay Steps Monitored Extraction, amplification, and detection Extraction, amplification, and detection Number of Targets Monitored in One Assay Multiple Multiple 4 Differences Assay Compatibility Cepheid Xpert CT/NG Assay Cepheid Xpert GBS LB Assay Positive Control Chlamydia trachomatis Neisseria gonorrhoeae Streptococcus agalactiae Negative Control Human epithelial cells Lactobacillus acidophilus K. Standard/Guidance Document Referenced (if applicable): Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline. CLSI Document EP25-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2009. Evaluation of Precision of Quantitative Measurement Methods: Approved Guideline. CLSI Document EP05-A3, 2014. L. Test Principle: Not applicable; this is control material to monitor performance of an in vitro diagnostic test. The test principle defaults to the Cepheid Xpert CT/NG assay, K121710. M. Performance Characteristics: 1. Analytical performance: a. Reproducibility: The Cepheid Xpert CT/NG Control Panel was evaluated at three testing sites with two operators at each site (total of six operators). Three lots of the control material were tested with the Cepheid Xpert CT/NG assay on the Cepheid Xpert Instrument, over five days. Each positive and negative control was tested in three replicates on each day. There were seven ERROR results (assay aborted due to instrument or reagent problem) and one INVALID result (failure of the internal control/s). Those samples were retested using a new control swab according to the Instructions for Use. All testing utilized the Xpert Vaginal/Endocervical Swab Specimen Collection kit. The Cepheid Xpert CT/NG Assay detects one target for CT) and two different targets for NG (NG2 and NG4). Both NG targets need to be positive for the Xpert CT/NG Assay to return a positive NG result. The qualitative results from the reproducibility study are summarized below. 5 Positive Control Target % Agreement with Expected Results, by Test Site Site 1 1,3 Site 22,3 Site 3 Overall C. trachomatis 31/31 (100%) 31/31 (100%) 30/30 (100%) 92/92 (100%) N. gonorrhoeae (NG2) 31/31 (100%) 31/31 (100%) 30/30 (100%) 92/92 (100%) N. gonorrhoeae (NG4) 31/31 (100%) 31/31 (100%) 30/30 (100%) 92/92 (100%) SPC 31/31 (100%) 31/31 (100%) 30/30 (100%) 92/92 (100%) SPC: Sample Processing Control 1Three ERROR results were observed; in all cases a new control was retested and the expected results were obtained. 2Two ERROR results and one INVALID result were obtained; in all cases a new control was retested and the expected results were obtained. 3 More than 30 measurements were taken as extra positive controls were ran during re-tests of negative controls. Negative Control Target % Agreement with Expected Results, by Test Site Site 11,2,3* Site 21,2,3 Site 3 Overall SAC 33/33 (100%) 34/34 (100%) 30/30 (100%) 97/97 (100%) SPC 33/33 (100%) 34/34 (100%) 30/30 (100%) 97/97 (100%) SAC: Sample Adequacy Control; SPC: Sample Processing Control 1Two ERROR results were observed; in all cases a new control was retested and the expected results were obtained. 2One Negative Control at site 1 and two Negative Control at Site 2 generated a positive result for NG2 target, however, the qualitative results were negative in each case because the Xpert CT/NG Assay requires both NG2 and NG4 targets to be positive in order to return a positive result for NG. In accordance with the assay protocol, the work area was cleaned and the controls were retested. 3More than 30 measurements were taken as extra positive controls were ran during re-tests of negative controls. The calculated average Ct score values and the associated standard deviation (SD) and percent coefficient of variation (% CV) across the three testing sites obtained in the reproducibility study are shown below. Positive Control Target N Mean (Ct) SD %CV C.
Panel: |
idK190223_s0_e2000 | K190223.txt | predicate device name | Cepheid Xpert GBS LB Control Panel | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K190223 B. Purpose for Submission: To obtain a substantial equivalence determination for the Cepheid Xpert CT/NG Control Panel for use with the Cepheid Xpert CT/NG Assay on the GeneXpert Instrument System. C. Measurand: Nucleic acids from inactivated Chlamydia trachomatis and Neisseria gonorrhoeae (positive control) and from human epithelial cells (negative control). D. Type of Test: The Cepheid Xpert CT/NG Control Panel is an external assayed quality control material (positive and negative) designed to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae in genitourinary specimens when used with the Cepheid Xpert CT/NG assay on the Cepheid Xpert Instrument System. E. Applicant: Microbiologics, Inc. F. Proprietary and Established Names: Trade Name: Cepheid Xpert CT/NG Control Panel G. Regulatory Information: 1. Regulation section: 21 CFR 866.3920, Assayed quality control material for clinical microbiology assays 2. Classification: Class II (Special Controls) 3. Product code: 2 PMN Assayed external control material for microbiology nucleic acid amplification assays 4. Panel: (83) Microbiology H. Intended Use: 1. Intended use: The Cepheid Xpert CT/NG Control Panel is intended for use as an external assayed positive and negative quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) performed with the Cepheid Xpert CT/NG assay on the GeneXpert Instrument System. The controls consist of cultured and inactivated Chlamydia trachomatis and Neisseria gonorrhoeae as the positive control and human cells as the negative control. The Cepheid Xpert CT/NG Control Panel is not intended to replace manufacturer controls provided with the device. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For in vitro diagnostic use only. For prescription use only. 3. Special instrument requirements: Cepheid Xpert Instrument System I. Device Description: The Cepheid Xpert CT/NG Control Panel is a quality control material provided to the customer as six individually packaged positive and negative swabs. Each positive swab consists of inactivated Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) microorganisms. Each negative swab consists of human epithelial cells. The positive swabs were prepared with cultured, inactivated and quantified stocks of CT and NG. The negative swabs were prepared from human cells derived from a cultured cell line, certified for sterility, and quantified in cells/mL. 3 J. Substantial Equivalence Information: 1. Predicate device name(s): Cepheid Xpert GBS LB Control Panel 2. Predicate 510(k) number(s): K182472 3. Comparison with predicate: K190223 K182472 (Predicate) Device Trade Name Cepheid Xpert CT/NG Control Panel Cepheid Xpert GBS LB Control Panel Similarities Intended Use The Cepheid Xpert CT/NG Control Panel is intended for use as an external assayed positive and negative quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) performed with the Cepheid Xpert CT/NG assay on the GeneXpert Instrument System. The controls consist of cultured and inactivated Chlamydia trachomatis and Neisseria gonorrhoeae as the positive control and human cells as the negative control. The Cepheid Xpert CT/NG Control Panel is not intended to replace manufacturer controls provided with the device. External assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Group B Streptococcus (GBS) performed with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. The controls comprise cultured and inactivated Streptococcus agalactiae as the positive control and Lactobacillus acidophilus as the negative control. The Cepheid Xpert GBS LB Control Panel is not intended to replace the manufacturer controls provided with the device. Physical Format Swabs Swabs Composition Inactivated microorganisms Inactivated microorganisms Test System Cepheid GeneXpert System Cepheid GeneXpert System Directions for Use Process like patient sample Process like patient sample Assay Steps Monitored Extraction, amplification, and detection Extraction, amplification, and detection Number of Targets Monitored in One Assay Multiple Multiple 4 Differences Assay Compatibility Cepheid Xpert CT/NG Assay Cepheid Xpert GBS LB Assay Positive Control Chlamydia trachomatis Neisseria gonorrhoeae Streptococcus agalactiae Negative Control Human epithelial cells Lactobacillus acidophilus K. Standard/Guidance Document Referenced (if applicable): Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline. CLSI Document EP25-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2009. Evaluation of Precision of Quantitative Measurement Methods: Approved Guideline. CLSI Document EP05-A3, 2014. L. Test Principle: Not applicable; this is control material to monitor performance of an in vitro diagnostic test. The test principle defaults to the Cepheid Xpert CT/NG assay, K121710. M. Performance Characteristics: 1. Analytical performance: a. Reproducibility: The Cepheid Xpert CT/NG Control Panel was evaluated at three testing sites with two operators at each site (total of six operators). Three lots of the control material were tested with the Cepheid Xpert CT/NG assay on the Cepheid Xpert Instrument, over five days. Each positive and negative control was tested in three replicates on each day. There were seven ERROR results (assay aborted due to instrument or reagent problem) and one INVALID result (failure of the internal control/s). Those samples were retested using a new control swab according to the Instructions for Use. All testing utilized the Xpert Vaginal/Endocervical Swab Specimen Collection kit. The Cepheid Xpert CT/NG Assay detects one target for CT) and two different targets for NG (NG2 and NG4). Both NG targets need to be positive for the Xpert CT/NG Assay to return a positive NG result. The qualitative results from the reproducibility study are summarized below. 5 Positive Control Target % Agreement with Expected Results, by Test Site Site 1 1,3 Site 22,3 Site 3 Overall C. trachomatis 31/31 (100%) 31/31 (100%) 30/30 (100%) 92/92 (100%) N. gonorrhoeae (NG2) 31/31 (100%) 31/31 (100%) 30/30 (100%) 92/92 (100%) N. gonorrhoeae (NG4) 31/31 (100%) 31/31 (100%) 30/30 (100%) 92/92 (100%) SPC 31/31 (100%) 31/31 (100%) 30/30 (100%) 92/92 (100%) SPC: Sample Processing Control 1Three ERROR results were observed; in all cases a new control was retested and the expected results were obtained. 2Two ERROR results and one INVALID result were obtained; in all cases a new control was retested and the expected results were obtained. 3 More than 30 measurements were taken as extra positive controls were ran during re-tests of negative controls. Negative Control Target % Agreement with Expected Results, by Test Site Site 11,2,3* Site 21,2,3 Site 3 Overall SAC 33/33 (100%) 34/34 (100%) 30/30 (100%) 97/97 (100%) SPC 33/33 (100%) 34/34 (100%) 30/30 (100%) 97/97 (100%) SAC: Sample Adequacy Control; SPC: Sample Processing Control 1Two ERROR results were observed; in all cases a new control was retested and the expected results were obtained. 2One Negative Control at site 1 and two Negative Control at Site 2 generated a positive result for NG2 target, however, the qualitative results were negative in each case because the Xpert CT/NG Assay requires both NG2 and NG4 targets to be positive in order to return a positive result for NG. In accordance with the assay protocol, the work area was cleaned and the controls were retested. 3More than 30 measurements were taken as extra positive controls were ran during re-tests of negative controls. The calculated average Ct score values and the associated standard deviation (SD) and percent coefficient of variation (% CV) across the three testing sites obtained in the reproducibility study are shown below. Positive Control Target N Mean (Ct) SD %CV C.
Predicate device name: |
idK190223_s0_e2000 | K190223.txt | applicant | Microbiologics, Inc. | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K190223 B. Purpose for Submission: To obtain a substantial equivalence determination for the Cepheid Xpert CT/NG Control Panel for use with the Cepheid Xpert CT/NG Assay on the GeneXpert Instrument System. C. Measurand: Nucleic acids from inactivated Chlamydia trachomatis and Neisseria gonorrhoeae (positive control) and from human epithelial cells (negative control). D. Type of Test: The Cepheid Xpert CT/NG Control Panel is an external assayed quality control material (positive and negative) designed to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae in genitourinary specimens when used with the Cepheid Xpert CT/NG assay on the Cepheid Xpert Instrument System. E. Applicant: Microbiologics, Inc. F. Proprietary and Established Names: Trade Name: Cepheid Xpert CT/NG Control Panel G. Regulatory Information: 1. Regulation section: 21 CFR 866.3920, Assayed quality control material for clinical microbiology assays 2. Classification: Class II (Special Controls) 3. Product code: 2 PMN Assayed external control material for microbiology nucleic acid amplification assays 4. Panel: (83) Microbiology H. Intended Use: 1. Intended use: The Cepheid Xpert CT/NG Control Panel is intended for use as an external assayed positive and negative quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) performed with the Cepheid Xpert CT/NG assay on the GeneXpert Instrument System. The controls consist of cultured and inactivated Chlamydia trachomatis and Neisseria gonorrhoeae as the positive control and human cells as the negative control. The Cepheid Xpert CT/NG Control Panel is not intended to replace manufacturer controls provided with the device. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For in vitro diagnostic use only. For prescription use only. 3. Special instrument requirements: Cepheid Xpert Instrument System I. Device Description: The Cepheid Xpert CT/NG Control Panel is a quality control material provided to the customer as six individually packaged positive and negative swabs. Each positive swab consists of inactivated Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) microorganisms. Each negative swab consists of human epithelial cells. The positive swabs were prepared with cultured, inactivated and quantified stocks of CT and NG. The negative swabs were prepared from human cells derived from a cultured cell line, certified for sterility, and quantified in cells/mL. 3 J. Substantial Equivalence Information: 1. Predicate device name(s): Cepheid Xpert GBS LB Control Panel 2. Predicate 510(k) number(s): K182472 3. Comparison with predicate: K190223 K182472 (Predicate) Device Trade Name Cepheid Xpert CT/NG Control Panel Cepheid Xpert GBS LB Control Panel Similarities Intended Use The Cepheid Xpert CT/NG Control Panel is intended for use as an external assayed positive and negative quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) performed with the Cepheid Xpert CT/NG assay on the GeneXpert Instrument System. The controls consist of cultured and inactivated Chlamydia trachomatis and Neisseria gonorrhoeae as the positive control and human cells as the negative control. The Cepheid Xpert CT/NG Control Panel is not intended to replace manufacturer controls provided with the device. External assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Group B Streptococcus (GBS) performed with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. The controls comprise cultured and inactivated Streptococcus agalactiae as the positive control and Lactobacillus acidophilus as the negative control. The Cepheid Xpert GBS LB Control Panel is not intended to replace the manufacturer controls provided with the device. Physical Format Swabs Swabs Composition Inactivated microorganisms Inactivated microorganisms Test System Cepheid GeneXpert System Cepheid GeneXpert System Directions for Use Process like patient sample Process like patient sample Assay Steps Monitored Extraction, amplification, and detection Extraction, amplification, and detection Number of Targets Monitored in One Assay Multiple Multiple 4 Differences Assay Compatibility Cepheid Xpert CT/NG Assay Cepheid Xpert GBS LB Assay Positive Control Chlamydia trachomatis Neisseria gonorrhoeae Streptococcus agalactiae Negative Control Human epithelial cells Lactobacillus acidophilus K. Standard/Guidance Document Referenced (if applicable): Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline. CLSI Document EP25-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2009. Evaluation of Precision of Quantitative Measurement Methods: Approved Guideline. CLSI Document EP05-A3, 2014. L. Test Principle: Not applicable; this is control material to monitor performance of an in vitro diagnostic test. The test principle defaults to the Cepheid Xpert CT/NG assay, K121710. M. Performance Characteristics: 1. Analytical performance: a. Reproducibility: The Cepheid Xpert CT/NG Control Panel was evaluated at three testing sites with two operators at each site (total of six operators). Three lots of the control material were tested with the Cepheid Xpert CT/NG assay on the Cepheid Xpert Instrument, over five days. Each positive and negative control was tested in three replicates on each day. There were seven ERROR results (assay aborted due to instrument or reagent problem) and one INVALID result (failure of the internal control/s). Those samples were retested using a new control swab according to the Instructions for Use. All testing utilized the Xpert Vaginal/Endocervical Swab Specimen Collection kit. The Cepheid Xpert CT/NG Assay detects one target for CT) and two different targets for NG (NG2 and NG4). Both NG targets need to be positive for the Xpert CT/NG Assay to return a positive NG result. The qualitative results from the reproducibility study are summarized below. 5 Positive Control Target % Agreement with Expected Results, by Test Site Site 1 1,3 Site 22,3 Site 3 Overall C. trachomatis 31/31 (100%) 31/31 (100%) 30/30 (100%) 92/92 (100%) N. gonorrhoeae (NG2) 31/31 (100%) 31/31 (100%) 30/30 (100%) 92/92 (100%) N. gonorrhoeae (NG4) 31/31 (100%) 31/31 (100%) 30/30 (100%) 92/92 (100%) SPC 31/31 (100%) 31/31 (100%) 30/30 (100%) 92/92 (100%) SPC: Sample Processing Control 1Three ERROR results were observed; in all cases a new control was retested and the expected results were obtained. 2Two ERROR results and one INVALID result were obtained; in all cases a new control was retested and the expected results were obtained. 3 More than 30 measurements were taken as extra positive controls were ran during re-tests of negative controls. Negative Control Target % Agreement with Expected Results, by Test Site Site 11,2,3* Site 21,2,3 Site 3 Overall SAC 33/33 (100%) 34/34 (100%) 30/30 (100%) 97/97 (100%) SPC 33/33 (100%) 34/34 (100%) 30/30 (100%) 97/97 (100%) SAC: Sample Adequacy Control; SPC: Sample Processing Control 1Two ERROR results were observed; in all cases a new control was retested and the expected results were obtained. 2One Negative Control at site 1 and two Negative Control at Site 2 generated a positive result for NG2 target, however, the qualitative results were negative in each case because the Xpert CT/NG Assay requires both NG2 and NG4 targets to be positive in order to return a positive result for NG. In accordance with the assay protocol, the work area was cleaned and the controls were retested. 3More than 30 measurements were taken as extra positive controls were ran during re-tests of negative controls. The calculated average Ct score values and the associated standard deviation (SD) and percent coefficient of variation (% CV) across the three testing sites obtained in the reproducibility study are shown below. Positive Control Target N Mean (Ct) SD %CV C.
Applicant: |
idK190223_s0_e2000 | K190223.txt | proprietary and established names | Cepheid Xpert CT/NG Control Panel | IAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K190223 B. Purpose for Submission: To obtain a substantial equivalence determination for the Cepheid Xpert CT/NG Control Panel for use with the Cepheid Xpert CT/NG Assay on the GeneXpert Instrument System. C. Measurand: Nucleic acids from inactivated Chlamydia trachomatis and Neisseria gonorrhoeae (positive control) and from human epithelial cells (negative control). D. Type of Test: The Cepheid Xpert CT/NG Control Panel is an external assayed quality control material (positive and negative) designed to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae in genitourinary specimens when used with the Cepheid Xpert CT/NG assay on the Cepheid Xpert Instrument System. E. Applicant: Microbiologics, Inc. F. Proprietary and Established Names: Trade Name: Cepheid Xpert CT/NG Control Panel G. Regulatory Information: 1. Regulation section: 21 CFR 866.3920, Assayed quality control material for clinical microbiology assays 2. Classification: Class II (Special Controls) 3. Product code: 2 PMN Assayed external control material for microbiology nucleic acid amplification assays 4. Panel: (83) Microbiology H. Intended Use: 1. Intended use: The Cepheid Xpert CT/NG Control Panel is intended for use as an external assayed positive and negative quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) performed with the Cepheid Xpert CT/NG assay on the GeneXpert Instrument System. The controls consist of cultured and inactivated Chlamydia trachomatis and Neisseria gonorrhoeae as the positive control and human cells as the negative control. The Cepheid Xpert CT/NG Control Panel is not intended to replace manufacturer controls provided with the device. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For in vitro diagnostic use only. For prescription use only. 3. Special instrument requirements: Cepheid Xpert Instrument System I. Device Description: The Cepheid Xpert CT/NG Control Panel is a quality control material provided to the customer as six individually packaged positive and negative swabs. Each positive swab consists of inactivated Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) microorganisms. Each negative swab consists of human epithelial cells. The positive swabs were prepared with cultured, inactivated and quantified stocks of CT and NG. The negative swabs were prepared from human cells derived from a cultured cell line, certified for sterility, and quantified in cells/mL. 3 J. Substantial Equivalence Information: 1. Predicate device name(s): Cepheid Xpert GBS LB Control Panel 2. Predicate 510(k) number(s): K182472 3. Comparison with predicate: K190223 K182472 (Predicate) Device Trade Name Cepheid Xpert CT/NG Control Panel Cepheid Xpert GBS LB Control Panel Similarities Intended Use The Cepheid Xpert CT/NG Control Panel is intended for use as an external assayed positive and negative quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) performed with the Cepheid Xpert CT/NG assay on the GeneXpert Instrument System. The controls consist of cultured and inactivated Chlamydia trachomatis and Neisseria gonorrhoeae as the positive control and human cells as the negative control. The Cepheid Xpert CT/NG Control Panel is not intended to replace manufacturer controls provided with the device. External assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Group B Streptococcus (GBS) performed with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. The controls comprise cultured and inactivated Streptococcus agalactiae as the positive control and Lactobacillus acidophilus as the negative control. The Cepheid Xpert GBS LB Control Panel is not intended to replace the manufacturer controls provided with the device. Physical Format Swabs Swabs Composition Inactivated microorganisms Inactivated microorganisms Test System Cepheid GeneXpert System Cepheid GeneXpert System Directions for Use Process like patient sample Process like patient sample Assay Steps Monitored Extraction, amplification, and detection Extraction, amplification, and detection Number of Targets Monitored in One Assay Multiple Multiple 4 Differences Assay Compatibility Cepheid Xpert CT/NG Assay Cepheid Xpert GBS LB Assay Positive Control Chlamydia trachomatis Neisseria gonorrhoeae Streptococcus agalactiae Negative Control Human epithelial cells Lactobacillus acidophilus K. Standard/Guidance Document Referenced (if applicable): Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline. CLSI Document EP25-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2009. Evaluation of Precision of Quantitative Measurement Methods: Approved Guideline. CLSI Document EP05-A3, 2014. L. Test Principle: Not applicable; this is control material to monitor performance of an in vitro diagnostic test. The test principle defaults to the Cepheid Xpert CT/NG assay, K121710. M. Performance Characteristics: 1. Analytical performance: a. Reproducibility: The Cepheid Xpert CT/NG Control Panel was evaluated at three testing sites with two operators at each site (total of six operators). Three lots of the control material were tested with the Cepheid Xpert CT/NG assay on the Cepheid Xpert Instrument, over five days. Each positive and negative control was tested in three replicates on each day. There were seven ERROR results (assay aborted due to instrument or reagent problem) and one INVALID result (failure of the internal control/s). Those samples were retested using a new control swab according to the Instructions for Use. All testing utilized the Xpert Vaginal/Endocervical Swab Specimen Collection kit. The Cepheid Xpert CT/NG Assay detects one target for CT) and two different targets for NG (NG2 and NG4). Both NG targets need to be positive for the Xpert CT/NG Assay to return a positive NG result. The qualitative results from the reproducibility study are summarized below. 5 Positive Control Target % Agreement with Expected Results, by Test Site Site 1 1,3 Site 22,3 Site 3 Overall C. trachomatis 31/31 (100%) 31/31 (100%) 30/30 (100%) 92/92 (100%) N. gonorrhoeae (NG2) 31/31 (100%) 31/31 (100%) 30/30 (100%) 92/92 (100%) N. gonorrhoeae (NG4) 31/31 (100%) 31/31 (100%) 30/30 (100%) 92/92 (100%) SPC 31/31 (100%) 31/31 (100%) 30/30 (100%) 92/92 (100%) SPC: Sample Processing Control 1Three ERROR results were observed; in all cases a new control was retested and the expected results were obtained. 2Two ERROR results and one INVALID result were obtained; in all cases a new control was retested and the expected results were obtained. 3 More than 30 measurements were taken as extra positive controls were ran during re-tests of negative controls. Negative Control Target % Agreement with Expected Results, by Test Site Site 11,2,3* Site 21,2,3 Site 3 Overall SAC 33/33 (100%) 34/34 (100%) 30/30 (100%) 97/97 (100%) SPC 33/33 (100%) 34/34 (100%) 30/30 (100%) 97/97 (100%) SAC: Sample Adequacy Control; SPC: Sample Processing Control 1Two ERROR results were observed; in all cases a new control was retested and the expected results were obtained. 2One Negative Control at site 1 and two Negative Control at Site 2 generated a positive result for NG2 target, however, the qualitative results were negative in each case because the Xpert CT/NG Assay requires both NG2 and NG4 targets to be positive in order to return a positive result for NG. In accordance with the assay protocol, the work area was cleaned and the controls were retested. 3More than 30 measurements were taken as extra positive controls were ran during re-tests of negative controls. The calculated average Ct score values and the associated standard deviation (SD) and percent coefficient of variation (% CV) across the three testing sites obtained in the reproducibility study are shown below. Positive Control Target N Mean (Ct) SD %CV C.
Proprietary and established names: |
idK190223_s0_e2000 | K190223.txt | regulation section | 21 CFR 866.3920, Assayed quality control material for clinical microbiology assays | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K190223 B. Purpose for Submission: To obtain a substantial equivalence determination for the Cepheid Xpert CT/NG Control Panel for use with the Cepheid Xpert CT/NG Assay on the GeneXpert Instrument System. C. Measurand: Nucleic acids from inactivated Chlamydia trachomatis and Neisseria gonorrhoeae (positive control) and from human epithelial cells (negative control). D. Type of Test: The Cepheid Xpert CT/NG Control Panel is an external assayed quality control material (positive and negative) designed to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae in genitourinary specimens when used with the Cepheid Xpert CT/NG assay on the Cepheid Xpert Instrument System. E. Applicant: Microbiologics, Inc. F. Proprietary and Established Names: Trade Name: Cepheid Xpert CT/NG Control Panel G. Regulatory Information: 1. Regulation section: 21 CFR 866.3920, Assayed quality control material for clinical microbiology assays 2. Classification: Class II (Special Controls) 3. Product code: 2 PMN Assayed external control material for microbiology nucleic acid amplification assays 4. Panel: (83) Microbiology H. Intended Use: 1. Intended use: The Cepheid Xpert CT/NG Control Panel is intended for use as an external assayed positive and negative quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) performed with the Cepheid Xpert CT/NG assay on the GeneXpert Instrument System. The controls consist of cultured and inactivated Chlamydia trachomatis and Neisseria gonorrhoeae as the positive control and human cells as the negative control. The Cepheid Xpert CT/NG Control Panel is not intended to replace manufacturer controls provided with the device. 2. Indication(s) for use: Same as Intended Use. 3. Special conditions for use statement(s): For in vitro diagnostic use only. For prescription use only. 3. Special instrument requirements: Cepheid Xpert Instrument System I. Device Description: The Cepheid Xpert CT/NG Control Panel is a quality control material provided to the customer as six individually packaged positive and negative swabs. Each positive swab consists of inactivated Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) microorganisms. Each negative swab consists of human epithelial cells. The positive swabs were prepared with cultured, inactivated and quantified stocks of CT and NG. The negative swabs were prepared from human cells derived from a cultured cell line, certified for sterility, and quantified in cells/mL. 3 J. Substantial Equivalence Information: 1. Predicate device name(s): Cepheid Xpert GBS LB Control Panel 2. Predicate 510(k) number(s): K182472 3. Comparison with predicate: K190223 K182472 (Predicate) Device Trade Name Cepheid Xpert CT/NG Control Panel Cepheid Xpert GBS LB Control Panel Similarities Intended Use The Cepheid Xpert CT/NG Control Panel is intended for use as an external assayed positive and negative quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) performed with the Cepheid Xpert CT/NG assay on the GeneXpert Instrument System. The controls consist of cultured and inactivated Chlamydia trachomatis and Neisseria gonorrhoeae as the positive control and human cells as the negative control. The Cepheid Xpert CT/NG Control Panel is not intended to replace manufacturer controls provided with the device. External assayed positive and negative quality control materials to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Group B Streptococcus (GBS) performed with the Cepheid Xpert GBS LB Assay on the GeneXpert Instrument System. The controls comprise cultured and inactivated Streptococcus agalactiae as the positive control and Lactobacillus acidophilus as the negative control. The Cepheid Xpert GBS LB Control Panel is not intended to replace the manufacturer controls provided with the device. Physical Format Swabs Swabs Composition Inactivated microorganisms Inactivated microorganisms Test System Cepheid GeneXpert System Cepheid GeneXpert System Directions for Use Process like patient sample Process like patient sample Assay Steps Monitored Extraction, amplification, and detection Extraction, amplification, and detection Number of Targets Monitored in One Assay Multiple Multiple 4 Differences Assay Compatibility Cepheid Xpert CT/NG Assay Cepheid Xpert GBS LB Assay Positive Control Chlamydia trachomatis Neisseria gonorrhoeae Streptococcus agalactiae Negative Control Human epithelial cells Lactobacillus acidophilus K. Standard/Guidance Document Referenced (if applicable): Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline. CLSI Document EP25-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2009. Evaluation of Precision of Quantitative Measurement Methods: Approved Guideline. CLSI Document EP05-A3, 2014. L. Test Principle: Not applicable; this is control material to monitor performance of an in vitro diagnostic test. The test principle defaults to the Cepheid Xpert CT/NG assay, K121710. M. Performance Characteristics: 1. Analytical performance: a. Reproducibility: The Cepheid Xpert CT/NG Control Panel was evaluated at three testing sites with two operators at each site (total of six operators). Three lots of the control material were tested with the Cepheid Xpert CT/NG assay on the Cepheid Xpert Instrument, over five days. Each positive and negative control was tested in three replicates on each day. There were seven ERROR results (assay aborted due to instrument or reagent problem) and one INVALID result (failure of the internal control/s). Those samples were retested using a new control swab according to the Instructions for Use. All testing utilized the Xpert Vaginal/Endocervical Swab Specimen Collection kit. The Cepheid Xpert CT/NG Assay detects one target for CT) and two different targets for NG (NG2 and NG4). Both NG targets need to be positive for the Xpert CT/NG Assay to return a positive NG result. The qualitative results from the reproducibility study are summarized below. 5 Positive Control Target % Agreement with Expected Results, by Test Site Site 1 1,3 Site 22,3 Site 3 Overall C. trachomatis 31/31 (100%) 31/31 (100%) 30/30 (100%) 92/92 (100%) N. gonorrhoeae (NG2) 31/31 (100%) 31/31 (100%) 30/30 (100%) 92/92 (100%) N. gonorrhoeae (NG4) 31/31 (100%) 31/31 (100%) 30/30 (100%) 92/92 (100%) SPC 31/31 (100%) 31/31 (100%) 30/30 (100%) 92/92 (100%) SPC: Sample Processing Control 1Three ERROR results were observed; in all cases a new control was retested and the expected results were obtained. 2Two ERROR results and one INVALID result were obtained; in all cases a new control was retested and the expected results were obtained. 3 More than 30 measurements were taken as extra positive controls were ran during re-tests of negative controls. Negative Control Target % Agreement with Expected Results, by Test Site Site 11,2,3* Site 21,2,3 Site 3 Overall SAC 33/33 (100%) 34/34 (100%) 30/30 (100%) 97/97 (100%) SPC 33/33 (100%) 34/34 (100%) 30/30 (100%) 97/97 (100%) SAC: Sample Adequacy Control; SPC: Sample Processing Control 1Two ERROR results were observed; in all cases a new control was retested and the expected results were obtained. 2One Negative Control at site 1 and two Negative Control at Site 2 generated a positive result for NG2 target, however, the qualitative results were negative in each case because the Xpert CT/NG Assay requires both NG2 and NG4 targets to be positive in order to return a positive result for NG. In accordance with the assay protocol, the work area was cleaned and the controls were retested. 3More than 30 measurements were taken as extra positive controls were ran during re-tests of negative controls. The calculated average Ct score values and the associated standard deviation (SD) and percent coefficient of variation (% CV) across the three testing sites obtained in the reproducibility study are shown below. Positive Control Target N Mean (Ct) SD %CV C.
Regulation section: |
idK190223_s4000_e6000 | K190223.txt | proposed labeling | The labeling supports the finding of substantial equivalence for this device. | SAC (Negative Control) 27.2 27.5 0.3 27.6 0.4 3. An in-use stability of the hydrated Control swabs (i.e., placed in the Transport Reagent Tube from the Xpert Vaginal/Endocervical Specimen Collection kit) was evaluated at room temperature (21°C) over the period of 6 hours. The controls 9 were tested in three replicates immediately after hydration (t=0), and then again at 4 hours, and at 6 hours. All samples produced expected results after 4 and 6 hours, with minimal variation. The summary of the data collected over 6 hours is shown below. In-Use Stability Study Using Swab Specimen Collection Kit Target N Mean (Ct) SD %CV Positive Control C. trachomatis 9 30.9 0.357 1.16 N. gonorrhoeae NG2 9 30.4 0.186 0.61 N. gonorrhoeae NG4 9 30.1 0.331 1.10 Negative Control Human Epithelial Cells 9 27.2 0.194 0.72 4. A similar study was performed with control swabs hydrated in the Transport Reagent Tube from the Xpert Urine Specimen Collection Kit. Due to the low fluid volume in the Transport Reagent Tube from the Xpert Urine Specimen Collection Kit, it is necessary for the user to add 1.5 mL of nuclease-free water to properly hydrate the swab. This is part of the Cepheid Xpert CT/NG Control Panel instructions for use. In-Use Stability Study Using Urine Specimen Collection Kit Target N Mean (Ct) SD %CV Positive Control C. trachomatis 9 32.9 0.537 1.63 N. gonorrhoeae NG2 9 32.3 0.464 1.44 N. gonorrhoeae NG4 9 32.1 0.675 2.10 Negative Control Human Epithelial Cells 9 28.3 0.450 1.59 5. Shipping Stability The Cepheid CT/NG Controls are packaged in sealed foil pouches with desiccants to prevent effects of high humidity. However, the product may be exposed and affected by high temperatures. The product is shipped by FedEx for delivery in two days, however, delays may be encountered. The effect of exposure to high temperatures was evaluated at 43°C after 14 days (the worst-case delay scenario) in the accelerated stability study described above. The observed change in Ct values (a measure of product deterioration) was less than 5%, ranging from 2.2% to 4.3% for the positive control (for all the microbial targets), and from 2.2% to 4.5% for the negative control (human cells target), across three lots of the product. Expected Values: The Cepheid CT/NG Control Panel consists of qualitative positive and negative controls. The following are the expected assay results. 10 Control Expected Assay Result Interpretation Positive Control CT Detected NG Detected CT target and NG target DNA sequences are detected. Negative Control CT Not Detected NG Not Detected Neither CT nor NG target DNA sequences are detected. d. Detection limit: Not applicable. e. Analytical Specificity: Not applicable. f. Assay cut-off: Not applicable. 2. Comparison studies: a. Method comparison with predicate device: Not applicable. b. Matrix comparison: Not applicable. 3. Clinical studies: a. Clinical Sensitivity: Not applicable. b. Clinical specificity: Not applicable. c. Other clinical supportive data (when a. and b. are not applicable): Not applicable. 11 4. Clinical cut-off: Not applicable. N. Proposed Labeling: The labeling supports the finding of substantial equivalence for this device. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision
Proposed labeling: |
idK190223_s4000_e6000 | K190223.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision | .7 SAC (Negative Control) 27.2 27.5 0.3 27.6 0.4 3. An in-use stability of the hydrated Control swabs (i.e., placed in the Transport Reagent Tube from the Xpert Vaginal/Endocervical Specimen Collection kit) was evaluated at room temperature (21°C) over the period of 6 hours. The controls 9 were tested in three replicates immediately after hydration (t=0), and then again at 4 hours, and at 6 hours. All samples produced expected results after 4 and 6 hours, with minimal variation. The summary of the data collected over 6 hours is shown below. In-Use Stability Study Using Swab Specimen Collection Kit Target N Mean (Ct) SD %CV Positive Control C. trachomatis 9 30.9 0.357 1.16 N. gonorrhoeae NG2 9 30.4 0.186 0.61 N. gonorrhoeae NG4 9 30.1 0.331 1.10 Negative Control Human Epithelial Cells 9 27.2 0.194 0.72 4. A similar study was performed with control swabs hydrated in the Transport Reagent Tube from the Xpert Urine Specimen Collection Kit. Due to the low fluid volume in the Transport Reagent Tube from the Xpert Urine Specimen Collection Kit, it is necessary for the user to add 1.5 mL of nuclease-free water to properly hydrate the swab. This is part of the Cepheid Xpert CT/NG Control Panel instructions for use. In-Use Stability Study Using Urine Specimen Collection Kit Target N Mean (Ct) SD %CV Positive Control C. trachomatis 9 32.9 0.537 1.63 N. gonorrhoeae NG2 9 32.3 0.464 1.44 N. gonorrhoeae NG4 9 32.1 0.675 2.10 Negative Control Human Epithelial Cells 9 28.3 0.450 1.59 5. Shipping Stability The Cepheid CT/NG Controls are packaged in sealed foil pouches with desiccants to prevent effects of high humidity. However, the product may be exposed and affected by high temperatures. The product is shipped by FedEx for delivery in two days, however, delays may be encountered. The effect of exposure to high temperatures was evaluated at 43°C after 14 days (the worst-case delay scenario) in the accelerated stability study described above. The observed change in Ct values (a measure of product deterioration) was less than 5%, ranging from 2.2% to 4.3% for the positive control (for all the microbial targets), and from 2.2% to 4.5% for the negative control (human cells target), across three lots of the product. Expected Values: The Cepheid CT/NG Control Panel consists of qualitative positive and negative controls. The following are the expected assay results. 10 Control Expected Assay Result Interpretation Positive Control CT Detected NG Detected CT target and NG target DNA sequences are detected. Negative Control CT Not Detected NG Not Detected Neither CT nor NG target DNA sequences are detected. d. Detection limit: Not applicable. e. Analytical Specificity: Not applicable. f. Assay cut-off: Not applicable. 2. Comparison studies: a. Method comparison with predicate device: Not applicable. b. Matrix comparison: Not applicable. 3. Clinical studies: a. Clinical Sensitivity: Not applicable. b. Clinical specificity: Not applicable. c. Other clinical supportive data (when a. and b. are not applicable): Not applicable. 11 4. Clinical cut-off: Not applicable. N. Proposed Labeling: The labeling supports the finding of substantial equivalence for this device. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision
Conclusion: |
idK162042_s0_e2000 | K162042.txt | purpose for submission | New device | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k162042 B. Purpose for Submission: New device C. Measurand: Plasma glucose from central venous catheter blood draw D. Type of Test: Quantitative, mid-infrared (MIR) spectrophotometric assay E. Applicant: OptiScan Biomedical Corporation F. Proprietary and Established Names: OptiScanner 5000 Glucose Monitoring System G. Regulatory Information: Product Code Classification Regulation Panel LZF Pump, Infusion Analytic Sampling II 21 CFR §880.5725 Infusion Pump General Hospital (80) PYV Hospital Continuous Glucose Monitoring System 21 CFR §862.1345 Glucose test system Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See Indication(s) for use below. 2
2. Indication(s) for use: The OptiScanner 5000 Glucose Monitoring System is an automated, bedside glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) in the surgical intensive care unit. The system collects a venous whole blood sample via connection to a central venous catheter, centrifuges the sample, and measures the plasma glucose concentration. It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia. The OptiScanner 5000 Glucose Monitoring System is for in vitro diagnostic use. 3. Special conditions for use statement(s): Prescription use only. Contraindications: - Patients that are <18 years of age - Women who are pregnant or nursing - Patients undergoing Magnetic Resonance Imaging (MRI) or Computerized Tomography (CT) Warnings: - The OptiScanner disposable cartridge should be used only by medical personnel having specific training in, and understanding of, the techniques associated with such devices and procedures. - The disposable cartridge is for single patient use only. Do not re-sterilize. Do not re-
use. Re-use of the cartridge may pose infection to the patient due to non-sterile condition and cross contamination of blood. - Do not use the cartridge if the packaging is received open or damaged. - The OptiScanner has not been tested for use in the operating room. - The OptiScanner should be connected to the most proximal port when using a Central Venous Catheter. If the most proximal port is not available, use next most proximal port for OptiScanner primary connection. - Do not infuse anything above the OptiScanner primary connection. - Do not rest containers of liquids on top of the OptiScanner enclosure. - Avoid infusion of any glucose containing solutions adjacent to the OptiScanner port. Infuse these solutions in the most distal port available, as clinical research has shown glucose administered through the distal port does not affect OptiScanner accuracy. - Be advised of possible complications associated with central venous catheterization. These include but are not limited to: vessel wall perforation, cardiac tamponade, air embolism, catheter embolism, thrombosis, bacteremia, septicemia. - Due to the risk of further blood loss, do not use the OptiScanner in patients with low hematocrit (less than 15%). - The OptiScanner should not be used concomitantly with the intravenous administration of high dose ascorbate (IVC) for the treatment of patients with cancer. - Use caution when OptiScanner readings are below 60 and above 300 mg/dL as these concentrations have not been studied in the intended use population. 3
- Use caution when OptiScanner is reading in the hypoglycemic range (<70 mg/dL). The comparator measurement check may not be sufficient to indicate instances of severe hypoglycemia, especially when the Low Glucose Alarm is set to 80 mg/dL. - Though central line occlusions were not studied in the trial, it should be noted that the CVCs utilized with the OptiScanner may become occluded. In the event of a line occlusion, follow hospital protocol to clear the line. - Certain substances should be used with caution with the OptiScanner. Refer to the Interfering Substance section in Chapter 7 for more information. - Not all substances which could potentially interfere with OptiScanner measurement accuracy have been identified. Following the instructions regarding the daily reference check is imperative to screen for potential offsets. - No additives of any kind are to be passed through or injected into the saline bag or saline flush line. - Do not use the OptiScanner in patients that are being administered intravenous immunoglobulin therapies (IVIG). These therapies may generate false glucose measurements. Examples of IVIG therapies are Gamimune N, HepaGam B, Octagam, Vaccinia Immune Globulin, and WinRho SDF Liquid. - Do not use the OptiScanner in patients that have used peritoneal dialysis solutions any time in the past week. These solutions may generate false glucose measurements. - Do not inject heparin or any other substances into the saline bag. - If moving the OptiScanner without disconnecting from the patient, always maintain the connection between the venous line and the OptiScanner patient line. - Do not use stopcocks. Ensure catheter lines are not pinched off by clamps, hemostats or physically kinked. - Use of stopcocks or catheters with valves (for example, Groshong catheters) that potentially alter, restrict or impede flow should never be used with the OptiScanner. - Only use normal, 0.9% saline with the OptiScanner. Do not use saline with dextrose, ringers, or any other substance or additive to connect to the OptiScanner. - The disposable cartridge must be primed before being connected to the patient. Do NOT connect to patient until priming is complete. - Be sure there is no air in the catheter lumen when connecting the OptiScanner to the patient. If present, air could be returned to the patient. Ensure catheter is primed per manufacturer’s instructions for use. 4. Special instrument requirements: OptiScanner 5000 Instrument I. Device Description: The OptiScanner 5000 Glucose Monitoring System is comprised of the OptiScanner 5000 Instrument, a transportation cart, disposable OptiScanner cartridges (sold separately), and a barcode scanner with USB connectivity. The OptiScanner 5000 instrument houses the mechanisms that automatically draw and return blood to the patient, analyzes the sample and calculates the glucose value. The disposable cartridges are sterile, single use only, and designed for use on a single patient for up to 72 hours. 4
J. Substantial Equivalence Information: 1. Predicate device name(s): VIA Medical Corp Pump/Blood Chemistry Monitor 2. Predicate 510(k) number(s): k951739 3. Comparison with predicate: Due to an administrative error, the predicate device indications for use in the similarities table below erroneously stated ‘same’ and has now been corrected to ‘similar’. Similarities Item Candidate Device: OptiScanner 5000 Glucose Monitoring System Predicate Device: VIA Medical Corp Pump/Blood Chemistry Monitor (k951739) Indications for Use Intended for hospital bedside glucose monitoring for detecting trends and tracking patterns in glucose Similar Differences Item Candidate Device: OptiScanner 5000 Glucose Monitoring System Predicate Device: VIA Medical Corp Pump/Blood Chemistry Monitor (k951739) Patient use population Patients in the surgical intensive care unit (SICU) Hospitalized patient Test Principle Spectrophotometric Enzymatic Sample Type Venous blood Venous or arterial blood Point of access for sample Central venous catheter Peripheral venous and arterial lines Sampling Frequency 15 minutes 5 minutes K. Standard/Guidance Document Referenced (if applicable): IEC 60601-1-2, Medical electrical equipment Part 1. General Requirements for Basic Safety and Essential Performance – Collateral Standard Electromagnetic compatibility – Requirements and Tests Electromagnetic Compatibility - Requirements and Tests (2007). 5
ISO 10993-1 (2009), Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. ISO 11137-1 (2010), Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013)]. ISO 11137-2 (2013), Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose. ISO 11607-1 (2006), Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems [Including: Amendment 1 (2014)]. ISO 11607-2 (2006), Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes [Including: Amendment 1 (2014)]. L. Test Principle: The OptiScanner 5000 Glucose Monitoring System samples and measure blood glucose levels every 15 minutes. Samples (~ 3 mL) are drawn from the patients central venous catheter (CVC)
Purpose for submission: |
idK162042_s0_e2000 | K162042.txt | measurand | Plasma glucose from central venous catheter blood draw | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k162042 B. Purpose for Submission: New device C. Measurand: Plasma glucose from central venous catheter blood draw D. Type of Test: Quantitative, mid-infrared (MIR) spectrophotometric assay E. Applicant: OptiScan Biomedical Corporation F. Proprietary and Established Names: OptiScanner 5000 Glucose Monitoring System G. Regulatory Information: Product Code Classification Regulation Panel LZF Pump, Infusion Analytic Sampling II 21 CFR §880.5725 Infusion Pump General Hospital (80) PYV Hospital Continuous Glucose Monitoring System 21 CFR §862.1345 Glucose test system Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See Indication(s) for use below. 2
2. Indication(s) for use: The OptiScanner 5000 Glucose Monitoring System is an automated, bedside glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) in the surgical intensive care unit. The system collects a venous whole blood sample via connection to a central venous catheter, centrifuges the sample, and measures the plasma glucose concentration. It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia. The OptiScanner 5000 Glucose Monitoring System is for in vitro diagnostic use. 3. Special conditions for use statement(s): Prescription use only. Contraindications: - Patients that are <18 years of age - Women who are pregnant or nursing - Patients undergoing Magnetic Resonance Imaging (MRI) or Computerized Tomography (CT) Warnings: - The OptiScanner disposable cartridge should be used only by medical personnel having specific training in, and understanding of, the techniques associated with such devices and procedures. - The disposable cartridge is for single patient use only. Do not re-sterilize. Do not re-
use. Re-use of the cartridge may pose infection to the patient due to non-sterile condition and cross contamination of blood. - Do not use the cartridge if the packaging is received open or damaged. - The OptiScanner has not been tested for use in the operating room. - The OptiScanner should be connected to the most proximal port when using a Central Venous Catheter. If the most proximal port is not available, use next most proximal port for OptiScanner primary connection. - Do not infuse anything above the OptiScanner primary connection. - Do not rest containers of liquids on top of the OptiScanner enclosure. - Avoid infusion of any glucose containing solutions adjacent to the OptiScanner port. Infuse these solutions in the most distal port available, as clinical research has shown glucose administered through the distal port does not affect OptiScanner accuracy. - Be advised of possible complications associated with central venous catheterization. These include but are not limited to: vessel wall perforation, cardiac tamponade, air embolism, catheter embolism, thrombosis, bacteremia, septicemia. - Due to the risk of further blood loss, do not use the OptiScanner in patients with low hematocrit (less than 15%). - The OptiScanner should not be used concomitantly with the intravenous administration of high dose ascorbate (IVC) for the treatment of patients with cancer. - Use caution when OptiScanner readings are below 60 and above 300 mg/dL as these concentrations have not been studied in the intended use population. 3
- Use caution when OptiScanner is reading in the hypoglycemic range (<70 mg/dL). The comparator measurement check may not be sufficient to indicate instances of severe hypoglycemia, especially when the Low Glucose Alarm is set to 80 mg/dL. - Though central line occlusions were not studied in the trial, it should be noted that the CVCs utilized with the OptiScanner may become occluded. In the event of a line occlusion, follow hospital protocol to clear the line. - Certain substances should be used with caution with the OptiScanner. Refer to the Interfering Substance section in Chapter 7 for more information. - Not all substances which could potentially interfere with OptiScanner measurement accuracy have been identified. Following the instructions regarding the daily reference check is imperative to screen for potential offsets. - No additives of any kind are to be passed through or injected into the saline bag or saline flush line. - Do not use the OptiScanner in patients that are being administered intravenous immunoglobulin therapies (IVIG). These therapies may generate false glucose measurements. Examples of IVIG therapies are Gamimune N, HepaGam B, Octagam, Vaccinia Immune Globulin, and WinRho SDF Liquid. - Do not use the OptiScanner in patients that have used peritoneal dialysis solutions any time in the past week. These solutions may generate false glucose measurements. - Do not inject heparin or any other substances into the saline bag. - If moving the OptiScanner without disconnecting from the patient, always maintain the connection between the venous line and the OptiScanner patient line. - Do not use stopcocks. Ensure catheter lines are not pinched off by clamps, hemostats or physically kinked. - Use of stopcocks or catheters with valves (for example, Groshong catheters) that potentially alter, restrict or impede flow should never be used with the OptiScanner. - Only use normal, 0.9% saline with the OptiScanner. Do not use saline with dextrose, ringers, or any other substance or additive to connect to the OptiScanner. - The disposable cartridge must be primed before being connected to the patient. Do NOT connect to patient until priming is complete. - Be sure there is no air in the catheter lumen when connecting the OptiScanner to the patient. If present, air could be returned to the patient. Ensure catheter is primed per manufacturer’s instructions for use. 4. Special instrument requirements: OptiScanner 5000 Instrument I. Device Description: The OptiScanner 5000 Glucose Monitoring System is comprised of the OptiScanner 5000 Instrument, a transportation cart, disposable OptiScanner cartridges (sold separately), and a barcode scanner with USB connectivity. The OptiScanner 5000 instrument houses the mechanisms that automatically draw and return blood to the patient, analyzes the sample and calculates the glucose value. The disposable cartridges are sterile, single use only, and designed for use on a single patient for up to 72 hours. 4
J. Substantial Equivalence Information: 1. Predicate device name(s): VIA Medical Corp Pump/Blood Chemistry Monitor 2. Predicate 510(k) number(s): k951739 3. Comparison with predicate: Due to an administrative error, the predicate device indications for use in the similarities table below erroneously stated ‘same’ and has now been corrected to ‘similar’. Similarities Item Candidate Device: OptiScanner 5000 Glucose Monitoring System Predicate Device: VIA Medical Corp Pump/Blood Chemistry Monitor (k951739) Indications for Use Intended for hospital bedside glucose monitoring for detecting trends and tracking patterns in glucose Similar Differences Item Candidate Device: OptiScanner 5000 Glucose Monitoring System Predicate Device: VIA Medical Corp Pump/Blood Chemistry Monitor (k951739) Patient use population Patients in the surgical intensive care unit (SICU) Hospitalized patient Test Principle Spectrophotometric Enzymatic Sample Type Venous blood Venous or arterial blood Point of access for sample Central venous catheter Peripheral venous and arterial lines Sampling Frequency 15 minutes 5 minutes K. Standard/Guidance Document Referenced (if applicable): IEC 60601-1-2, Medical electrical equipment Part 1. General Requirements for Basic Safety and Essential Performance – Collateral Standard Electromagnetic compatibility – Requirements and Tests Electromagnetic Compatibility - Requirements and Tests (2007). 5
ISO 10993-1 (2009), Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. ISO 11137-1 (2010), Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013)]. ISO 11137-2 (2013), Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose. ISO 11607-1 (2006), Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems [Including: Amendment 1 (2014)]. ISO 11607-2 (2006), Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes [Including: Amendment 1 (2014)]. L. Test Principle: The OptiScanner 5000 Glucose Monitoring System samples and measure blood glucose levels every 15 minutes. Samples (~ 3 mL) are drawn from the patients central venous catheter (CVC)
Measurand: |
idK162042_s0_e2000 | K162042.txt | type of test | Quantitative, mid-infrared (MIR) spectrophotometric assay | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k162042 B. Purpose for Submission: New device C. Measurand: Plasma glucose from central venous catheter blood draw D. Type of Test: Quantitative, mid-infrared (MIR) spectrophotometric assay E. Applicant: OptiScan Biomedical Corporation F. Proprietary and Established Names: OptiScanner 5000 Glucose Monitoring System G. Regulatory Information: Product Code Classification Regulation Panel LZF Pump, Infusion Analytic Sampling II 21 CFR §880.5725 Infusion Pump General Hospital (80) PYV Hospital Continuous Glucose Monitoring System 21 CFR §862.1345 Glucose test system Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See Indication(s) for use below. 2
2. Indication(s) for use: The OptiScanner 5000 Glucose Monitoring System is an automated, bedside glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) in the surgical intensive care unit. The system collects a venous whole blood sample via connection to a central venous catheter, centrifuges the sample, and measures the plasma glucose concentration. It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia. The OptiScanner 5000 Glucose Monitoring System is for in vitro diagnostic use. 3. Special conditions for use statement(s): Prescription use only. Contraindications: - Patients that are <18 years of age - Women who are pregnant or nursing - Patients undergoing Magnetic Resonance Imaging (MRI) or Computerized Tomography (CT) Warnings: - The OptiScanner disposable cartridge should be used only by medical personnel having specific training in, and understanding of, the techniques associated with such devices and procedures. - The disposable cartridge is for single patient use only. Do not re-sterilize. Do not re-
use. Re-use of the cartridge may pose infection to the patient due to non-sterile condition and cross contamination of blood. - Do not use the cartridge if the packaging is received open or damaged. - The OptiScanner has not been tested for use in the operating room. - The OptiScanner should be connected to the most proximal port when using a Central Venous Catheter. If the most proximal port is not available, use next most proximal port for OptiScanner primary connection. - Do not infuse anything above the OptiScanner primary connection. - Do not rest containers of liquids on top of the OptiScanner enclosure. - Avoid infusion of any glucose containing solutions adjacent to the OptiScanner port. Infuse these solutions in the most distal port available, as clinical research has shown glucose administered through the distal port does not affect OptiScanner accuracy. - Be advised of possible complications associated with central venous catheterization. These include but are not limited to: vessel wall perforation, cardiac tamponade, air embolism, catheter embolism, thrombosis, bacteremia, septicemia. - Due to the risk of further blood loss, do not use the OptiScanner in patients with low hematocrit (less than 15%). - The OptiScanner should not be used concomitantly with the intravenous administration of high dose ascorbate (IVC) for the treatment of patients with cancer. - Use caution when OptiScanner readings are below 60 and above 300 mg/dL as these concentrations have not been studied in the intended use population. 3
- Use caution when OptiScanner is reading in the hypoglycemic range (<70 mg/dL). The comparator measurement check may not be sufficient to indicate instances of severe hypoglycemia, especially when the Low Glucose Alarm is set to 80 mg/dL. - Though central line occlusions were not studied in the trial, it should be noted that the CVCs utilized with the OptiScanner may become occluded. In the event of a line occlusion, follow hospital protocol to clear the line. - Certain substances should be used with caution with the OptiScanner. Refer to the Interfering Substance section in Chapter 7 for more information. - Not all substances which could potentially interfere with OptiScanner measurement accuracy have been identified. Following the instructions regarding the daily reference check is imperative to screen for potential offsets. - No additives of any kind are to be passed through or injected into the saline bag or saline flush line. - Do not use the OptiScanner in patients that are being administered intravenous immunoglobulin therapies (IVIG). These therapies may generate false glucose measurements. Examples of IVIG therapies are Gamimune N, HepaGam B, Octagam, Vaccinia Immune Globulin, and WinRho SDF Liquid. - Do not use the OptiScanner in patients that have used peritoneal dialysis solutions any time in the past week. These solutions may generate false glucose measurements. - Do not inject heparin or any other substances into the saline bag. - If moving the OptiScanner without disconnecting from the patient, always maintain the connection between the venous line and the OptiScanner patient line. - Do not use stopcocks. Ensure catheter lines are not pinched off by clamps, hemostats or physically kinked. - Use of stopcocks or catheters with valves (for example, Groshong catheters) that potentially alter, restrict or impede flow should never be used with the OptiScanner. - Only use normal, 0.9% saline with the OptiScanner. Do not use saline with dextrose, ringers, or any other substance or additive to connect to the OptiScanner. - The disposable cartridge must be primed before being connected to the patient. Do NOT connect to patient until priming is complete. - Be sure there is no air in the catheter lumen when connecting the OptiScanner to the patient. If present, air could be returned to the patient. Ensure catheter is primed per manufacturer’s instructions for use. 4. Special instrument requirements: OptiScanner 5000 Instrument I. Device Description: The OptiScanner 5000 Glucose Monitoring System is comprised of the OptiScanner 5000 Instrument, a transportation cart, disposable OptiScanner cartridges (sold separately), and a barcode scanner with USB connectivity. The OptiScanner 5000 instrument houses the mechanisms that automatically draw and return blood to the patient, analyzes the sample and calculates the glucose value. The disposable cartridges are sterile, single use only, and designed for use on a single patient for up to 72 hours. 4
J. Substantial Equivalence Information: 1. Predicate device name(s): VIA Medical Corp Pump/Blood Chemistry Monitor 2. Predicate 510(k) number(s): k951739 3. Comparison with predicate: Due to an administrative error, the predicate device indications for use in the similarities table below erroneously stated ‘same’ and has now been corrected to ‘similar’. Similarities Item Candidate Device: OptiScanner 5000 Glucose Monitoring System Predicate Device: VIA Medical Corp Pump/Blood Chemistry Monitor (k951739) Indications for Use Intended for hospital bedside glucose monitoring for detecting trends and tracking patterns in glucose Similar Differences Item Candidate Device: OptiScanner 5000 Glucose Monitoring System Predicate Device: VIA Medical Corp Pump/Blood Chemistry Monitor (k951739) Patient use population Patients in the surgical intensive care unit (SICU) Hospitalized patient Test Principle Spectrophotometric Enzymatic Sample Type Venous blood Venous or arterial blood Point of access for sample Central venous catheter Peripheral venous and arterial lines Sampling Frequency 15 minutes 5 minutes K. Standard/Guidance Document Referenced (if applicable): IEC 60601-1-2, Medical electrical equipment Part 1. General Requirements for Basic Safety and Essential Performance – Collateral Standard Electromagnetic compatibility – Requirements and Tests Electromagnetic Compatibility - Requirements and Tests (2007). 5
ISO 10993-1 (2009), Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. ISO 11137-1 (2010), Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013)]. ISO 11137-2 (2013), Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose. ISO 11607-1 (2006), Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems [Including: Amendment 1 (2014)]. ISO 11607-2 (2006), Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes [Including: Amendment 1 (2014)]. L. Test Principle: The OptiScanner 5000 Glucose Monitoring System samples and measure blood glucose levels every 15 minutes. Samples (~ 3 mL) are drawn from the patients central venous catheter (CVC)
Type of test: |
idK162042_s0_e2000 | K162042.txt | intended use | See Indication(s) for use below. | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k162042 B. Purpose for Submission: New device C. Measurand: Plasma glucose from central venous catheter blood draw D. Type of Test: Quantitative, mid-infrared (MIR) spectrophotometric assay E. Applicant: OptiScan Biomedical Corporation F. Proprietary and Established Names: OptiScanner 5000 Glucose Monitoring System G. Regulatory Information: Product Code Classification Regulation Panel LZF Pump, Infusion Analytic Sampling II 21 CFR §880.5725 Infusion Pump General Hospital (80) PYV Hospital Continuous Glucose Monitoring System 21 CFR §862.1345 Glucose test system Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See Indication(s) for use below. 2
2. Indication(s) for use: The OptiScanner 5000 Glucose Monitoring System is an automated, bedside glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) in the surgical intensive care unit. The system collects a venous whole blood sample via connection to a central venous catheter, centrifuges the sample, and measures the plasma glucose concentration. It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia. The OptiScanner 5000 Glucose Monitoring System is for in vitro diagnostic use. 3. Special conditions for use statement(s): Prescription use only. Contraindications: - Patients that are <18 years of age - Women who are pregnant or nursing - Patients undergoing Magnetic Resonance Imaging (MRI) or Computerized Tomography (CT) Warnings: - The OptiScanner disposable cartridge should be used only by medical personnel having specific training in, and understanding of, the techniques associated with such devices and procedures. - The disposable cartridge is for single patient use only. Do not re-sterilize. Do not re-
use. Re-use of the cartridge may pose infection to the patient due to non-sterile condition and cross contamination of blood. - Do not use the cartridge if the packaging is received open or damaged. - The OptiScanner has not been tested for use in the operating room. - The OptiScanner should be connected to the most proximal port when using a Central Venous Catheter. If the most proximal port is not available, use next most proximal port for OptiScanner primary connection. - Do not infuse anything above the OptiScanner primary connection. - Do not rest containers of liquids on top of the OptiScanner enclosure. - Avoid infusion of any glucose containing solutions adjacent to the OptiScanner port. Infuse these solutions in the most distal port available, as clinical research has shown glucose administered through the distal port does not affect OptiScanner accuracy. - Be advised of possible complications associated with central venous catheterization. These include but are not limited to: vessel wall perforation, cardiac tamponade, air embolism, catheter embolism, thrombosis, bacteremia, septicemia. - Due to the risk of further blood loss, do not use the OptiScanner in patients with low hematocrit (less than 15%). - The OptiScanner should not be used concomitantly with the intravenous administration of high dose ascorbate (IVC) for the treatment of patients with cancer. - Use caution when OptiScanner readings are below 60 and above 300 mg/dL as these concentrations have not been studied in the intended use population. 3
- Use caution when OptiScanner is reading in the hypoglycemic range (<70 mg/dL). The comparator measurement check may not be sufficient to indicate instances of severe hypoglycemia, especially when the Low Glucose Alarm is set to 80 mg/dL. - Though central line occlusions were not studied in the trial, it should be noted that the CVCs utilized with the OptiScanner may become occluded. In the event of a line occlusion, follow hospital protocol to clear the line. - Certain substances should be used with caution with the OptiScanner. Refer to the Interfering Substance section in Chapter 7 for more information. - Not all substances which could potentially interfere with OptiScanner measurement accuracy have been identified. Following the instructions regarding the daily reference check is imperative to screen for potential offsets. - No additives of any kind are to be passed through or injected into the saline bag or saline flush line. - Do not use the OptiScanner in patients that are being administered intravenous immunoglobulin therapies (IVIG). These therapies may generate false glucose measurements. Examples of IVIG therapies are Gamimune N, HepaGam B, Octagam, Vaccinia Immune Globulin, and WinRho SDF Liquid. - Do not use the OptiScanner in patients that have used peritoneal dialysis solutions any time in the past week. These solutions may generate false glucose measurements. - Do not inject heparin or any other substances into the saline bag. - If moving the OptiScanner without disconnecting from the patient, always maintain the connection between the venous line and the OptiScanner patient line. - Do not use stopcocks. Ensure catheter lines are not pinched off by clamps, hemostats or physically kinked. - Use of stopcocks or catheters with valves (for example, Groshong catheters) that potentially alter, restrict or impede flow should never be used with the OptiScanner. - Only use normal, 0.9% saline with the OptiScanner. Do not use saline with dextrose, ringers, or any other substance or additive to connect to the OptiScanner. - The disposable cartridge must be primed before being connected to the patient. Do NOT connect to patient until priming is complete. - Be sure there is no air in the catheter lumen when connecting the OptiScanner to the patient. If present, air could be returned to the patient. Ensure catheter is primed per manufacturer’s instructions for use. 4. Special instrument requirements: OptiScanner 5000 Instrument I. Device Description: The OptiScanner 5000 Glucose Monitoring System is comprised of the OptiScanner 5000 Instrument, a transportation cart, disposable OptiScanner cartridges (sold separately), and a barcode scanner with USB connectivity. The OptiScanner 5000 instrument houses the mechanisms that automatically draw and return blood to the patient, analyzes the sample and calculates the glucose value. The disposable cartridges are sterile, single use only, and designed for use on a single patient for up to 72 hours. 4
J. Substantial Equivalence Information: 1. Predicate device name(s): VIA Medical Corp Pump/Blood Chemistry Monitor 2. Predicate 510(k) number(s): k951739 3. Comparison with predicate: Due to an administrative error, the predicate device indications for use in the similarities table below erroneously stated ‘same’ and has now been corrected to ‘similar’. Similarities Item Candidate Device: OptiScanner 5000 Glucose Monitoring System Predicate Device: VIA Medical Corp Pump/Blood Chemistry Monitor (k951739) Indications for Use Intended for hospital bedside glucose monitoring for detecting trends and tracking patterns in glucose Similar Differences Item Candidate Device: OptiScanner 5000 Glucose Monitoring System Predicate Device: VIA Medical Corp Pump/Blood Chemistry Monitor (k951739) Patient use population Patients in the surgical intensive care unit (SICU) Hospitalized patient Test Principle Spectrophotometric Enzymatic Sample Type Venous blood Venous or arterial blood Point of access for sample Central venous catheter Peripheral venous and arterial lines Sampling Frequency 15 minutes 5 minutes K. Standard/Guidance Document Referenced (if applicable): IEC 60601-1-2, Medical electrical equipment Part 1. General Requirements for Basic Safety and Essential Performance – Collateral Standard Electromagnetic compatibility – Requirements and Tests Electromagnetic Compatibility - Requirements and Tests (2007). 5
ISO 10993-1 (2009), Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. ISO 11137-1 (2010), Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013)]. ISO 11137-2 (2013), Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose. ISO 11607-1 (2006), Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems [Including: Amendment 1 (2014)]. ISO 11607-2 (2006), Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes [Including: Amendment 1 (2014)]. L. Test Principle: The OptiScanner 5000 Glucose Monitoring System samples and measure blood glucose levels every 15 minutes. Samples (~ 3 mL) are drawn from the patients central venous catheter (CVC)
Intended use: |
idK162042_s0_e2000 | K162042.txt | predicate device name | VIA Medical Corp Pump/Blood Chemistry Monitor | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k162042 B. Purpose for Submission: New device C. Measurand: Plasma glucose from central venous catheter blood draw D. Type of Test: Quantitative, mid-infrared (MIR) spectrophotometric assay E. Applicant: OptiScan Biomedical Corporation F. Proprietary and Established Names: OptiScanner 5000 Glucose Monitoring System G. Regulatory Information: Product Code Classification Regulation Panel LZF Pump, Infusion Analytic Sampling II 21 CFR §880.5725 Infusion Pump General Hospital (80) PYV Hospital Continuous Glucose Monitoring System 21 CFR §862.1345 Glucose test system Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See Indication(s) for use below. 2
2. Indication(s) for use: The OptiScanner 5000 Glucose Monitoring System is an automated, bedside glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) in the surgical intensive care unit. The system collects a venous whole blood sample via connection to a central venous catheter, centrifuges the sample, and measures the plasma glucose concentration. It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia. The OptiScanner 5000 Glucose Monitoring System is for in vitro diagnostic use. 3. Special conditions for use statement(s): Prescription use only. Contraindications: - Patients that are <18 years of age - Women who are pregnant or nursing - Patients undergoing Magnetic Resonance Imaging (MRI) or Computerized Tomography (CT) Warnings: - The OptiScanner disposable cartridge should be used only by medical personnel having specific training in, and understanding of, the techniques associated with such devices and procedures. - The disposable cartridge is for single patient use only. Do not re-sterilize. Do not re-
use. Re-use of the cartridge may pose infection to the patient due to non-sterile condition and cross contamination of blood. - Do not use the cartridge if the packaging is received open or damaged. - The OptiScanner has not been tested for use in the operating room. - The OptiScanner should be connected to the most proximal port when using a Central Venous Catheter. If the most proximal port is not available, use next most proximal port for OptiScanner primary connection. - Do not infuse anything above the OptiScanner primary connection. - Do not rest containers of liquids on top of the OptiScanner enclosure. - Avoid infusion of any glucose containing solutions adjacent to the OptiScanner port. Infuse these solutions in the most distal port available, as clinical research has shown glucose administered through the distal port does not affect OptiScanner accuracy. - Be advised of possible complications associated with central venous catheterization. These include but are not limited to: vessel wall perforation, cardiac tamponade, air embolism, catheter embolism, thrombosis, bacteremia, septicemia. - Due to the risk of further blood loss, do not use the OptiScanner in patients with low hematocrit (less than 15%). - The OptiScanner should not be used concomitantly with the intravenous administration of high dose ascorbate (IVC) for the treatment of patients with cancer. - Use caution when OptiScanner readings are below 60 and above 300 mg/dL as these concentrations have not been studied in the intended use population. 3
- Use caution when OptiScanner is reading in the hypoglycemic range (<70 mg/dL). The comparator measurement check may not be sufficient to indicate instances of severe hypoglycemia, especially when the Low Glucose Alarm is set to 80 mg/dL. - Though central line occlusions were not studied in the trial, it should be noted that the CVCs utilized with the OptiScanner may become occluded. In the event of a line occlusion, follow hospital protocol to clear the line. - Certain substances should be used with caution with the OptiScanner. Refer to the Interfering Substance section in Chapter 7 for more information. - Not all substances which could potentially interfere with OptiScanner measurement accuracy have been identified. Following the instructions regarding the daily reference check is imperative to screen for potential offsets. - No additives of any kind are to be passed through or injected into the saline bag or saline flush line. - Do not use the OptiScanner in patients that are being administered intravenous immunoglobulin therapies (IVIG). These therapies may generate false glucose measurements. Examples of IVIG therapies are Gamimune N, HepaGam B, Octagam, Vaccinia Immune Globulin, and WinRho SDF Liquid. - Do not use the OptiScanner in patients that have used peritoneal dialysis solutions any time in the past week. These solutions may generate false glucose measurements. - Do not inject heparin or any other substances into the saline bag. - If moving the OptiScanner without disconnecting from the patient, always maintain the connection between the venous line and the OptiScanner patient line. - Do not use stopcocks. Ensure catheter lines are not pinched off by clamps, hemostats or physically kinked. - Use of stopcocks or catheters with valves (for example, Groshong catheters) that potentially alter, restrict or impede flow should never be used with the OptiScanner. - Only use normal, 0.9% saline with the OptiScanner. Do not use saline with dextrose, ringers, or any other substance or additive to connect to the OptiScanner. - The disposable cartridge must be primed before being connected to the patient. Do NOT connect to patient until priming is complete. - Be sure there is no air in the catheter lumen when connecting the OptiScanner to the patient. If present, air could be returned to the patient. Ensure catheter is primed per manufacturer’s instructions for use. 4. Special instrument requirements: OptiScanner 5000 Instrument I. Device Description: The OptiScanner 5000 Glucose Monitoring System is comprised of the OptiScanner 5000 Instrument, a transportation cart, disposable OptiScanner cartridges (sold separately), and a barcode scanner with USB connectivity. The OptiScanner 5000 instrument houses the mechanisms that automatically draw and return blood to the patient, analyzes the sample and calculates the glucose value. The disposable cartridges are sterile, single use only, and designed for use on a single patient for up to 72 hours. 4
J. Substantial Equivalence Information: 1. Predicate device name(s): VIA Medical Corp Pump/Blood Chemistry Monitor 2. Predicate 510(k) number(s): k951739 3. Comparison with predicate: Due to an administrative error, the predicate device indications for use in the similarities table below erroneously stated ‘same’ and has now been corrected to ‘similar’. Similarities Item Candidate Device: OptiScanner 5000 Glucose Monitoring System Predicate Device: VIA Medical Corp Pump/Blood Chemistry Monitor (k951739) Indications for Use Intended for hospital bedside glucose monitoring for detecting trends and tracking patterns in glucose Similar Differences Item Candidate Device: OptiScanner 5000 Glucose Monitoring System Predicate Device: VIA Medical Corp Pump/Blood Chemistry Monitor (k951739) Patient use population Patients in the surgical intensive care unit (SICU) Hospitalized patient Test Principle Spectrophotometric Enzymatic Sample Type Venous blood Venous or arterial blood Point of access for sample Central venous catheter Peripheral venous and arterial lines Sampling Frequency 15 minutes 5 minutes K. Standard/Guidance Document Referenced (if applicable): IEC 60601-1-2, Medical electrical equipment Part 1. General Requirements for Basic Safety and Essential Performance – Collateral Standard Electromagnetic compatibility – Requirements and Tests Electromagnetic Compatibility - Requirements and Tests (2007). 5
ISO 10993-1 (2009), Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. ISO 11137-1 (2010), Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013)]. ISO 11137-2 (2013), Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose. ISO 11607-1 (2006), Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems [Including: Amendment 1 (2014)]. ISO 11607-2 (2006), Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes [Including: Amendment 1 (2014)]. L. Test Principle: The OptiScanner 5000 Glucose Monitoring System samples and measure blood glucose levels every 15 minutes. Samples (~ 3 mL) are drawn from the patients central venous catheter (CVC)
Predicate device name: |
idK162042_s0_e2000 | K162042.txt | applicant | OptiScan Biomedical Corporation | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k162042 B. Purpose for Submission: New device C. Measurand: Plasma glucose from central venous catheter blood draw D. Type of Test: Quantitative, mid-infrared (MIR) spectrophotometric assay E. Applicant: OptiScan Biomedical Corporation F. Proprietary and Established Names: OptiScanner 5000 Glucose Monitoring System G. Regulatory Information: Product Code Classification Regulation Panel LZF Pump, Infusion Analytic Sampling II 21 CFR §880.5725 Infusion Pump General Hospital (80) PYV Hospital Continuous Glucose Monitoring System 21 CFR §862.1345 Glucose test system Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See Indication(s) for use below. 2
2. Indication(s) for use: The OptiScanner 5000 Glucose Monitoring System is an automated, bedside glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) in the surgical intensive care unit. The system collects a venous whole blood sample via connection to a central venous catheter, centrifuges the sample, and measures the plasma glucose concentration. It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia. The OptiScanner 5000 Glucose Monitoring System is for in vitro diagnostic use. 3. Special conditions for use statement(s): Prescription use only. Contraindications: - Patients that are <18 years of age - Women who are pregnant or nursing - Patients undergoing Magnetic Resonance Imaging (MRI) or Computerized Tomography (CT) Warnings: - The OptiScanner disposable cartridge should be used only by medical personnel having specific training in, and understanding of, the techniques associated with such devices and procedures. - The disposable cartridge is for single patient use only. Do not re-sterilize. Do not re-
use. Re-use of the cartridge may pose infection to the patient due to non-sterile condition and cross contamination of blood. - Do not use the cartridge if the packaging is received open or damaged. - The OptiScanner has not been tested for use in the operating room. - The OptiScanner should be connected to the most proximal port when using a Central Venous Catheter. If the most proximal port is not available, use next most proximal port for OptiScanner primary connection. - Do not infuse anything above the OptiScanner primary connection. - Do not rest containers of liquids on top of the OptiScanner enclosure. - Avoid infusion of any glucose containing solutions adjacent to the OptiScanner port. Infuse these solutions in the most distal port available, as clinical research has shown glucose administered through the distal port does not affect OptiScanner accuracy. - Be advised of possible complications associated with central venous catheterization. These include but are not limited to: vessel wall perforation, cardiac tamponade, air embolism, catheter embolism, thrombosis, bacteremia, septicemia. - Due to the risk of further blood loss, do not use the OptiScanner in patients with low hematocrit (less than 15%). - The OptiScanner should not be used concomitantly with the intravenous administration of high dose ascorbate (IVC) for the treatment of patients with cancer. - Use caution when OptiScanner readings are below 60 and above 300 mg/dL as these concentrations have not been studied in the intended use population. 3
- Use caution when OptiScanner is reading in the hypoglycemic range (<70 mg/dL). The comparator measurement check may not be sufficient to indicate instances of severe hypoglycemia, especially when the Low Glucose Alarm is set to 80 mg/dL. - Though central line occlusions were not studied in the trial, it should be noted that the CVCs utilized with the OptiScanner may become occluded. In the event of a line occlusion, follow hospital protocol to clear the line. - Certain substances should be used with caution with the OptiScanner. Refer to the Interfering Substance section in Chapter 7 for more information. - Not all substances which could potentially interfere with OptiScanner measurement accuracy have been identified. Following the instructions regarding the daily reference check is imperative to screen for potential offsets. - No additives of any kind are to be passed through or injected into the saline bag or saline flush line. - Do not use the OptiScanner in patients that are being administered intravenous immunoglobulin therapies (IVIG). These therapies may generate false glucose measurements. Examples of IVIG therapies are Gamimune N, HepaGam B, Octagam, Vaccinia Immune Globulin, and WinRho SDF Liquid. - Do not use the OptiScanner in patients that have used peritoneal dialysis solutions any time in the past week. These solutions may generate false glucose measurements. - Do not inject heparin or any other substances into the saline bag. - If moving the OptiScanner without disconnecting from the patient, always maintain the connection between the venous line and the OptiScanner patient line. - Do not use stopcocks. Ensure catheter lines are not pinched off by clamps, hemostats or physically kinked. - Use of stopcocks or catheters with valves (for example, Groshong catheters) that potentially alter, restrict or impede flow should never be used with the OptiScanner. - Only use normal, 0.9% saline with the OptiScanner. Do not use saline with dextrose, ringers, or any other substance or additive to connect to the OptiScanner. - The disposable cartridge must be primed before being connected to the patient. Do NOT connect to patient until priming is complete. - Be sure there is no air in the catheter lumen when connecting the OptiScanner to the patient. If present, air could be returned to the patient. Ensure catheter is primed per manufacturer’s instructions for use. 4. Special instrument requirements: OptiScanner 5000 Instrument I. Device Description: The OptiScanner 5000 Glucose Monitoring System is comprised of the OptiScanner 5000 Instrument, a transportation cart, disposable OptiScanner cartridges (sold separately), and a barcode scanner with USB connectivity. The OptiScanner 5000 instrument houses the mechanisms that automatically draw and return blood to the patient, analyzes the sample and calculates the glucose value. The disposable cartridges are sterile, single use only, and designed for use on a single patient for up to 72 hours. 4
J. Substantial Equivalence Information: 1. Predicate device name(s): VIA Medical Corp Pump/Blood Chemistry Monitor 2. Predicate 510(k) number(s): k951739 3. Comparison with predicate: Due to an administrative error, the predicate device indications for use in the similarities table below erroneously stated ‘same’ and has now been corrected to ‘similar’. Similarities Item Candidate Device: OptiScanner 5000 Glucose Monitoring System Predicate Device: VIA Medical Corp Pump/Blood Chemistry Monitor (k951739) Indications for Use Intended for hospital bedside glucose monitoring for detecting trends and tracking patterns in glucose Similar Differences Item Candidate Device: OptiScanner 5000 Glucose Monitoring System Predicate Device: VIA Medical Corp Pump/Blood Chemistry Monitor (k951739) Patient use population Patients in the surgical intensive care unit (SICU) Hospitalized patient Test Principle Spectrophotometric Enzymatic Sample Type Venous blood Venous or arterial blood Point of access for sample Central venous catheter Peripheral venous and arterial lines Sampling Frequency 15 minutes 5 minutes K. Standard/Guidance Document Referenced (if applicable): IEC 60601-1-2, Medical electrical equipment Part 1. General Requirements for Basic Safety and Essential Performance – Collateral Standard Electromagnetic compatibility – Requirements and Tests Electromagnetic Compatibility - Requirements and Tests (2007). 5
ISO 10993-1 (2009), Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. ISO 11137-1 (2010), Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013)]. ISO 11137-2 (2013), Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose. ISO 11607-1 (2006), Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems [Including: Amendment 1 (2014)]. ISO 11607-2 (2006), Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes [Including: Amendment 1 (2014)]. L. Test Principle: The OptiScanner 5000 Glucose Monitoring System samples and measure blood glucose levels every 15 minutes. Samples (~ 3 mL) are drawn from the patients central venous catheter (CVC)
Applicant: |
idK162042_s0_e2000 | K162042.txt | proprietary and established names | OptiScanner 5000 Glucose Monitoring System | ANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k162042 B. Purpose for Submission: New device C. Measurand: Plasma glucose from central venous catheter blood draw D. Type of Test: Quantitative, mid-infrared (MIR) spectrophotometric assay E. Applicant: OptiScan Biomedical Corporation F. Proprietary and Established Names: OptiScanner 5000 Glucose Monitoring System G. Regulatory Information: Product Code Classification Regulation Panel LZF Pump, Infusion Analytic Sampling II 21 CFR §880.5725 Infusion Pump General Hospital (80) PYV Hospital Continuous Glucose Monitoring System 21 CFR §862.1345 Glucose test system Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See Indication(s) for use below. 2
2. Indication(s) for use: The OptiScanner 5000 Glucose Monitoring System is an automated, bedside glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) in the surgical intensive care unit. The system collects a venous whole blood sample via connection to a central venous catheter, centrifuges the sample, and measures the plasma glucose concentration. It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia. The OptiScanner 5000 Glucose Monitoring System is for in vitro diagnostic use. 3. Special conditions for use statement(s): Prescription use only. Contraindications: - Patients that are <18 years of age - Women who are pregnant or nursing - Patients undergoing Magnetic Resonance Imaging (MRI) or Computerized Tomography (CT) Warnings: - The OptiScanner disposable cartridge should be used only by medical personnel having specific training in, and understanding of, the techniques associated with such devices and procedures. - The disposable cartridge is for single patient use only. Do not re-sterilize. Do not re-
use. Re-use of the cartridge may pose infection to the patient due to non-sterile condition and cross contamination of blood. - Do not use the cartridge if the packaging is received open or damaged. - The OptiScanner has not been tested for use in the operating room. - The OptiScanner should be connected to the most proximal port when using a Central Venous Catheter. If the most proximal port is not available, use next most proximal port for OptiScanner primary connection. - Do not infuse anything above the OptiScanner primary connection. - Do not rest containers of liquids on top of the OptiScanner enclosure. - Avoid infusion of any glucose containing solutions adjacent to the OptiScanner port. Infuse these solutions in the most distal port available, as clinical research has shown glucose administered through the distal port does not affect OptiScanner accuracy. - Be advised of possible complications associated with central venous catheterization. These include but are not limited to: vessel wall perforation, cardiac tamponade, air embolism, catheter embolism, thrombosis, bacteremia, septicemia. - Due to the risk of further blood loss, do not use the OptiScanner in patients with low hematocrit (less than 15%). - The OptiScanner should not be used concomitantly with the intravenous administration of high dose ascorbate (IVC) for the treatment of patients with cancer. - Use caution when OptiScanner readings are below 60 and above 300 mg/dL as these concentrations have not been studied in the intended use population. 3
- Use caution when OptiScanner is reading in the hypoglycemic range (<70 mg/dL). The comparator measurement check may not be sufficient to indicate instances of severe hypoglycemia, especially when the Low Glucose Alarm is set to 80 mg/dL. - Though central line occlusions were not studied in the trial, it should be noted that the CVCs utilized with the OptiScanner may become occluded. In the event of a line occlusion, follow hospital protocol to clear the line. - Certain substances should be used with caution with the OptiScanner. Refer to the Interfering Substance section in Chapter 7 for more information. - Not all substances which could potentially interfere with OptiScanner measurement accuracy have been identified. Following the instructions regarding the daily reference check is imperative to screen for potential offsets. - No additives of any kind are to be passed through or injected into the saline bag or saline flush line. - Do not use the OptiScanner in patients that are being administered intravenous immunoglobulin therapies (IVIG). These therapies may generate false glucose measurements. Examples of IVIG therapies are Gamimune N, HepaGam B, Octagam, Vaccinia Immune Globulin, and WinRho SDF Liquid. - Do not use the OptiScanner in patients that have used peritoneal dialysis solutions any time in the past week. These solutions may generate false glucose measurements. - Do not inject heparin or any other substances into the saline bag. - If moving the OptiScanner without disconnecting from the patient, always maintain the connection between the venous line and the OptiScanner patient line. - Do not use stopcocks. Ensure catheter lines are not pinched off by clamps, hemostats or physically kinked. - Use of stopcocks or catheters with valves (for example, Groshong catheters) that potentially alter, restrict or impede flow should never be used with the OptiScanner. - Only use normal, 0.9% saline with the OptiScanner. Do not use saline with dextrose, ringers, or any other substance or additive to connect to the OptiScanner. - The disposable cartridge must be primed before being connected to the patient. Do NOT connect to patient until priming is complete. - Be sure there is no air in the catheter lumen when connecting the OptiScanner to the patient. If present, air could be returned to the patient. Ensure catheter is primed per manufacturer’s instructions for use. 4. Special instrument requirements: OptiScanner 5000 Instrument I. Device Description: The OptiScanner 5000 Glucose Monitoring System is comprised of the OptiScanner 5000 Instrument, a transportation cart, disposable OptiScanner cartridges (sold separately), and a barcode scanner with USB connectivity. The OptiScanner 5000 instrument houses the mechanisms that automatically draw and return blood to the patient, analyzes the sample and calculates the glucose value. The disposable cartridges are sterile, single use only, and designed for use on a single patient for up to 72 hours. 4
J. Substantial Equivalence Information: 1. Predicate device name(s): VIA Medical Corp Pump/Blood Chemistry Monitor 2. Predicate 510(k) number(s): k951739 3. Comparison with predicate: Due to an administrative error, the predicate device indications for use in the similarities table below erroneously stated ‘same’ and has now been corrected to ‘similar’. Similarities Item Candidate Device: OptiScanner 5000 Glucose Monitoring System Predicate Device: VIA Medical Corp Pump/Blood Chemistry Monitor (k951739) Indications for Use Intended for hospital bedside glucose monitoring for detecting trends and tracking patterns in glucose Similar Differences Item Candidate Device: OptiScanner 5000 Glucose Monitoring System Predicate Device: VIA Medical Corp Pump/Blood Chemistry Monitor (k951739) Patient use population Patients in the surgical intensive care unit (SICU) Hospitalized patient Test Principle Spectrophotometric Enzymatic Sample Type Venous blood Venous or arterial blood Point of access for sample Central venous catheter Peripheral venous and arterial lines Sampling Frequency 15 minutes 5 minutes K. Standard/Guidance Document Referenced (if applicable): IEC 60601-1-2, Medical electrical equipment Part 1. General Requirements for Basic Safety and Essential Performance – Collateral Standard Electromagnetic compatibility – Requirements and Tests Electromagnetic Compatibility - Requirements and Tests (2007). 5
ISO 10993-1 (2009), Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. ISO 11137-1 (2010), Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013)]. ISO 11137-2 (2013), Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose. ISO 11607-1 (2006), Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems [Including: Amendment 1 (2014)]. ISO 11607-2 (2006), Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes [Including: Amendment 1 (2014)]. L. Test Principle: The OptiScanner 5000 Glucose Monitoring System samples and measure blood glucose levels every 15 minutes. Samples (~ 3 mL) are drawn from the patients central venous catheter (CVC)
Proprietary and established names: |
idK162042_s8000_e10000 | K162042.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. | Comparator ≤90 mg/dL True Alarm Rate (Sensitivity) 100% (3/3) 84% (98/116) False Alarm Rate 98% (158/161) 42% (72/170) Missed Alarm 0% (0/3) 16% (18/116) Specificity 94% (2,643/2,801) 97% (2,616/2,688) High Glucose Alarm Performance (±15 Minutes) Alarm at 150, Comparator ≥180 (hyperglycemia detection) Alarm at 150, Comparator ≥150 True Alarm Rate (Sensitivity) 99% (357/360) 92% (801/873) False Alarm Rate 60% (538/895) 14% (135/936) Missed Alarm 1% (3/360) 8% (72/873) Specificity 78% (1,906/2,444) 93% (1,796/1,931) Additional Alarms: The sponsor includes descriptions of additional alarms in the labeling. These include alarms for saline bag occlusion, air in line to patient, patient line occlusion, and occlusion during blood return. Human factors study A human factors-usability analysis was conducted according to EN62366-1:2015, Medical Devices – Application of Usability Engineering to Medical Devices. 19
Usability studies were performed by intended operators of the device to assess tasks determined to be high-risk. Based on the results of the primary summative usability test results, specific design changes were made to the OptiScanner to address usability test findings. A follow-up supplemental usability test was conducted to evaluate the changes to determine the effectiveness in their ability to mitigate the risk associated with the original usability study findings. The usability evaluations performed demonstrated that users understood the instructions provided in the labeling and that they could use the device safely. 4. Clinical cut-off: Not applicable. 5. Expected values/Reference range: Not applicable. N. Instrument Name: OptiScanner 5000 Instrument O. System Descriptions: 1. Modes of Operation: Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? Yes X or No ________ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes ________ or No X . 2. Software: FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types: Yes X or No ________ 3. Specimen Identification: The patient ID can be entered into the OptiScanner 5000 Glucose Monitoring System manually or by using the barcode scanner included with the system. The patient ID is displayed on the device screen along with the glucose measurement and glucose trend information. 20
4. Specimen Sampling and Handling: The venous blood drawn from the patient for measurement is immediately centrifuged in the disposable test cartridge to plasma and analyzed by the device. 5. Calibration: The OptiScanner 5000 requires no calibration by the user. 6. Quality Control: There is no quality control material for use with the OptiScanner 5000 Glucose Monitoring System. P. Other Supportive Instrument Performance Characteristics Data Not Covered In The “Performance Characteristics” Section above: 1. Hematocrit Study: The effect of different hematocrit levels on the performance of the OptiScanner 5000 was evaluated using donor blood samples with hematocrit levels adjusted to 15, 20, 25, 30, 35, 40, 45, 50, 55 and 60% spiked with glucose to achieve 5 concentrations ranging from 40 to 400 mg/dL (40, 100, 150, 250, 400 mg/dL). Results from the OptiScanner 5000 were compared with results obtained from the comparator, YSI-2300 analyzer. The % biases relative to YSI were acceptable and support the claimed hematocrit range of 15 to 60%. 2. Operating Conditions: The sponsor evaluated temperatures ranging from 20°C to 27°C (68°F – 80.6°F) and relative humidity (RH; non-condensing) ranging from 20% to 60%. OptiScanner 5000 results were compared to results obtained from the YSI-2300 analyzer using donor blood samples. Three temperature and humidity combinations were tested including low temperature/low humidity, average temperature and humidity (23°C/40% RH) humidity, and high temperature/high humidity. No significant effect (relative to YSI) was observed for the temperature and humidity combinations tested. The results support the claimed system operating conditions of a temperature range of 20°C to 27°C and relative humidity range of 32 to 60%. 3. Bubble Sensor: The device is designed to prevent air bubbles from reaching the patient. Two bubble sensors are incorporated into the patient line, which is part of the disposable cartridge, to detect bubbles and generate an alarm when bubbles are detected. Once bubbles are detected, the device stops the pump which prevents blood from being returned to the patient. The sponsor validated this feature and demonstrated that the bubble sensor functions as intended. 4. Biocompatibility The sponsor provided acceptable biocompatibility testing on finished and sterilized disposable cartridges that included: cytotoxicity, sensitization, irritation, systemic toxicity (acute), systemic toxicity (sub-acute), pyrogenicity, hemocompatibility, genotoxicity 21
(reverse mutation assay, chromosomal aberration, in vivo mouse micronucleus), and immunotoxicology tests. 5. Electromagnetic Compatibility and Electrical Safety: The sponsor provided appropriate documentation certifying that electromagnetic testing (EMC) has been performed and the OptiScanner 5000 Glucose Monitoring System was found to be compliant. The labeling includes a warning against the use of the OptiScanner 5000 near Magnetic Resonance Imaging (MRI) equipment or Computerized Tomography (CT) equipment. 6.
Cleaning and Disinfection: The sponsor provided disinfection efficacy testing demonstrating the chosen wipes (Clorox Healthcare Bleach Germicidal Wipes; EPA registration number 67619-12) were effective against Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Klebsialla Pneumoniae, and Mycobacterium terrae when on the exterior surfaces of the device and cart. Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. R. Conclusion: Due to an administrative error, additional conclusions were erroneously included and have now been removed. The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
Proposed labeling: |
idK162042_s8000_e10000 | K162042.txt | conclusion | Due to an administrative error, additional conclusions were erroneously included and have now been removed. The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | 90, Comparator ≤90 mg/dL True Alarm Rate (Sensitivity) 100% (3/3) 84% (98/116) False Alarm Rate 98% (158/161) 42% (72/170) Missed Alarm 0% (0/3) 16% (18/116) Specificity 94% (2,643/2,801) 97% (2,616/2,688) High Glucose Alarm Performance (±15 Minutes) Alarm at 150, Comparator ≥180 (hyperglycemia detection) Alarm at 150, Comparator ≥150 True Alarm Rate (Sensitivity) 99% (357/360) 92% (801/873) False Alarm Rate 60% (538/895) 14% (135/936) Missed Alarm 1% (3/360) 8% (72/873) Specificity 78% (1,906/2,444) 93% (1,796/1,931) Additional Alarms: The sponsor includes descriptions of additional alarms in the labeling. These include alarms for saline bag occlusion, air in line to patient, patient line occlusion, and occlusion during blood return. Human factors study A human factors-usability analysis was conducted according to EN62366-1:2015, Medical Devices – Application of Usability Engineering to Medical Devices. 19
Usability studies were performed by intended operators of the device to assess tasks determined to be high-risk. Based on the results of the primary summative usability test results, specific design changes were made to the OptiScanner to address usability test findings. A follow-up supplemental usability test was conducted to evaluate the changes to determine the effectiveness in their ability to mitigate the risk associated with the original usability study findings. The usability evaluations performed demonstrated that users understood the instructions provided in the labeling and that they could use the device safely. 4. Clinical cut-off: Not applicable. 5. Expected values/Reference range: Not applicable. N. Instrument Name: OptiScanner 5000 Instrument O. System Descriptions: 1. Modes of Operation: Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? Yes X or No ________ Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? Yes ________ or No X . 2. Software: FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types: Yes X or No ________ 3. Specimen Identification: The patient ID can be entered into the OptiScanner 5000 Glucose Monitoring System manually or by using the barcode scanner included with the system. The patient ID is displayed on the device screen along with the glucose measurement and glucose trend information. 20
4. Specimen Sampling and Handling: The venous blood drawn from the patient for measurement is immediately centrifuged in the disposable test cartridge to plasma and analyzed by the device. 5. Calibration: The OptiScanner 5000 requires no calibration by the user. 6. Quality Control: There is no quality control material for use with the OptiScanner 5000 Glucose Monitoring System. P. Other Supportive Instrument Performance Characteristics Data Not Covered In The “Performance Characteristics” Section above: 1. Hematocrit Study: The effect of different hematocrit levels on the performance of the OptiScanner 5000 was evaluated using donor blood samples with hematocrit levels adjusted to 15, 20, 25, 30, 35, 40, 45, 50, 55 and 60% spiked with glucose to achieve 5 concentrations ranging from 40 to 400 mg/dL (40, 100, 150, 250, 400 mg/dL). Results from the OptiScanner 5000 were compared with results obtained from the comparator, YSI-2300 analyzer. The % biases relative to YSI were acceptable and support the claimed hematocrit range of 15 to 60%. 2. Operating Conditions: The sponsor evaluated temperatures ranging from 20°C to 27°C (68°F – 80.6°F) and relative humidity (RH; non-condensing) ranging from 20% to 60%. OptiScanner 5000 results were compared to results obtained from the YSI-2300 analyzer using donor blood samples. Three temperature and humidity combinations were tested including low temperature/low humidity, average temperature and humidity (23°C/40% RH) humidity, and high temperature/high humidity. No significant effect (relative to YSI) was observed for the temperature and humidity combinations tested. The results support the claimed system operating conditions of a temperature range of 20°C to 27°C and relative humidity range of 32 to 60%. 3. Bubble Sensor: The device is designed to prevent air bubbles from reaching the patient. Two bubble sensors are incorporated into the patient line, which is part of the disposable cartridge, to detect bubbles and generate an alarm when bubbles are detected. Once bubbles are detected, the device stops the pump which prevents blood from being returned to the patient. The sponsor validated this feature and demonstrated that the bubble sensor functions as intended. 4. Biocompatibility The sponsor provided acceptable biocompatibility testing on finished and sterilized disposable cartridges that included: cytotoxicity, sensitization, irritation, systemic toxicity (acute), systemic toxicity (sub-acute), pyrogenicity, hemocompatibility, genotoxicity 21
(reverse mutation assay, chromosomal aberration, in vivo mouse micronucleus), and immunotoxicology tests. 5. Electromagnetic Compatibility and Electrical Safety: The sponsor provided appropriate documentation certifying that electromagnetic testing (EMC) has been performed and the OptiScanner 5000 Glucose Monitoring System was found to be compliant. The labeling includes a warning against the use of the OptiScanner 5000 near Magnetic Resonance Imaging (MRI) equipment or Computerized Tomography (CT) equipment. 6.
Cleaning and Disinfection: The sponsor provided disinfection efficacy testing demonstrating the chosen wipes (Clorox Healthcare Bleach Germicidal Wipes; EPA registration number 67619-12) were effective against Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Klebsialla Pneumoniae, and Mycobacterium terrae when on the exterior surfaces of the device and cart. Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. R. Conclusion: Due to an administrative error, additional conclusions were erroneously included and have now been removed. The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
Conclusion: |
idK192815_s0_e2000 | K192815.txt | purpose for submission | The purpose of this Traditional 510(k) Premarket Notification is to obtain FDA clearance for new reagents which have been added to the Elecsys BRAHMS PCT Test System. Additional reagents intended to minimize potentially interfering effects of biotin in a patient specimen have been added to the previously cleared product. | 1 of 20 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY I Background Information: The Elecsys BRAHMS PCT assay has been reformulated to address a 2017 FDA Safety Communication1 alerting the public, health care providers, lab personnel, and lab test developers that biotin can significantly interfere with certain lab tests and cause incorrect test results which may go undetected. A 510(k) Number K192815 B Applicant Roche Diagnostics C Proprietary and Established Names Elecsys BRAHMS PCT D Regulatory Information Product Code(s) Classification Regulation Section Panel PRI Class II 21 CFR 866.3215 - Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis MI - Microbiology II Submission/Device Overview: A Purpose for Submission: The purpose of this Traditional 510(k) Premarket Notification is to obtain FDA clearance for new reagents which have been added to the Elecsys BRAHMS PCT Test System. Additional reagents intended to minimize potentially interfering effects of biotin in a patient specimen have been added to the previously cleared product. B Measurand: 1 https://www.fda.gov/medical-devices/safety-communications/fda-warns-biotin-may-interfere-lab-tests-fda-safety-
communication K192815 - Page 2 of 20 Procalcitonin (PCT) C Type of Test: Quantitative, Electrochemiluminescence Immunoassay III Intended Use/Indications for Use: A Intended Use(s): See Indications for Use below. B Indication(s) for Use: Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 –EDTA, K3-EDTA and Li-Heparin). The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers. Used in conjunction with other laboratory findings and clinical assessments, Elecsys BRAHMS PCT is intended for use as follows: • to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock, • to determine the change in PCT level over time as an aid in assessing the cumulative 28-day risk of all-cause mortality for patients diagnosed with severe sepsis or septic shock in the ICU or when obtained in the emergency department or other medical wards prior to ICU admission, • to aid in decision making on antibiotic therapy, for inpatients or patients in the emergency department with suspected or confirmed lower respiratory tract infections (LRTI) – defined as community-acquired pneumonia (CAP), acute bronchitis, and acute exacerbation of chronic obstructive pulmonary disease (AECOPD), • to aid in decision making on antibiotic discontinuation for patients with suspected or confirmed sepsis. C Special Conditions for Use Statement(s): Rx - For Prescription Use Only Warnings and Precautions The Elecsys BRAHMS PCT is not indicated to be used as a stand-alone diagnostic assay and should be used in conjunction with clinical signs and symptoms of infection and other diagnostic evidence. In cases where the laboratory results do not agree with the clinical picture or history, additional tests should be K192815 - Page 3 of 20 performed. Changes in PCT should always be interpreted in the context of the clinical status of the patient and other laboratory results. Decisions regarding antibiotic therapy should NOT be based solely on procalcitonin concentrations. There is no uniformly recognized interpretation of the change in PCT concentration levels for the prediction of mortality, and overall mortality is strongly dependent on many factors, including pre-
existing patient risk factors and clinical course. The need to continue ICU care at Day 4 and other covariates (e.g., age, SOFA score) are also significant predictors of 28 day cumulative mortality risk. Validation of the Elecsys BRAHMS PCT test as an aid in predicting mortality was performed in a study population with an overall 28 day mortality of 22 %. Certain patient characteristics, such as severity of renal failure or insufficiency, may influence procalcitonin values and should be considered as potentially confounding clinical factors when interpreting PCT values. Increased PCT levels may be observed in severe illness such as polytrauma, burns, major surgery, prolonged or cardiogenic shock. PCT levels may not be elevated in patients infected by certain atypical pathogens, such as Chlamydia pneumoniae and Mycoplasma pneumoniae. The safety and performance of PCT-guided therapy for individuals younger than age 17 years, pregnant women, immunocompromised individuals or those on immunomodulatory agents, was not formally analyzed in the supportive clinical trials. D Special Instrument Requirements: The submission demonstrates performance on the cobas e 601 immunoassay analyzer. IV Device/System Characteristics: A Device Description: The Elecsys BRAHMS PCT assay is intended for use with the cobas e immunoassay analyzers, PCT Cal1 and Cal2 reagents, and the PreciControl PCT1 and PCT2 as part of the Elecsys BRAHMS PCT Kit. An optional Procalcitonin CalCheck product is also available. B Principle of Operation: The Elecsys BRAHMS PCT assay is a two-step sandwich immunoassay with streptavidin microparticles, biotinylated antibody and antibody labeled with ruthenium as well as an electrochemiluminescence detection system. Procalcitonin (PCT) in the sample reacts with these labeled antibodies to form a sandwich complex. This complex binds to streptavidin coated magnetic microparticles, which are magnetically captured onto an electrode. Application of voltage to the electrode induces chemiluminescence which is measured by a photomultiplier tube. Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent barcode. Total duration of assay: 18 minutes. K192815 - Page 4 of 20 • 1st incubation: Antigen in the sample (30 μL), a biotinylated monoclonal PCT-specific antibody, and a monoclonal PCT-specific antibody labeled with a ruthenium complex*) react to form a sandwich complex. • 2nd incubation: After addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin. • The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell M. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier. • Results are determined via a calibration curve which is instrument-specifically generated by 2-
point calibration and a master curve provided via the reagent barcode. (*):Tris(2,2'-bipyridyl)ruthenium(II)-complex (Ru(bpy)₃²⁺) C Reagents The reagent working solutions include: Rackpack (kit placed on analyzer) • M: Streptavidin-coated microparticles, • R1: Anti-PCT-Ab~biotin • R2: Anti-PCT-Ab~Ru(bpy)₃²⁺ The following change is proposed to block the interference of biotin with the Elecsys BRAHMS PCT assay: Roche is taking a one-step approach by adding an antibody to bind free biotin in the sample. For the neutralization of free biotin in serum and plasma, Roche developed an antibody which binds to free biotin. The antibodies are specific for free biotin and do not bind to, or interact with, the biotin-linker conjugates. V Substantial Equivalence Information: A Predicate Device Name(s): Elecsys BRAHMS PCT B Predicate 510(k) Number(s): K173927 C Comparison with Predicate(s): Device & Predicate Device(s): K192815 K173927 Device Trade Name Elecsys BRAHMS PCT Same K192815 - Page 5 of 20 Device & Predicate Device(s): K192815 K173927 General Device Characteristic Similarities Intended Use/ Indications for Use Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 –EDTA, K3-EDTA and Li-Heparin). The electrochemiluminescence immunoassay “ECLIA” is intended for use on Elecsys and cobas e immunoassay analyzers. Used in conjunction with other laboratory findings and clinical assessments, Elecsys BRAHMS PCT is intended for use as follows: • to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock, • to determine the change in PCT level over time as an aid in assessing
Purpose for submission: |
idK192815_s0_e2000 | K192815.txt | measurand | Procalcitonin (PCT) | 1 of 20 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY I Background Information: The Elecsys BRAHMS PCT assay has been reformulated to address a 2017 FDA Safety Communication1 alerting the public, health care providers, lab personnel, and lab test developers that biotin can significantly interfere with certain lab tests and cause incorrect test results which may go undetected. A 510(k) Number K192815 B Applicant Roche Diagnostics C Proprietary and Established Names Elecsys BRAHMS PCT D Regulatory Information Product Code(s) Classification Regulation Section Panel PRI Class II 21 CFR 866.3215 - Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis MI - Microbiology II Submission/Device Overview: A Purpose for Submission: The purpose of this Traditional 510(k) Premarket Notification is to obtain FDA clearance for new reagents which have been added to the Elecsys BRAHMS PCT Test System. Additional reagents intended to minimize potentially interfering effects of biotin in a patient specimen have been added to the previously cleared product. B Measurand: 1 https://www.fda.gov/medical-devices/safety-communications/fda-warns-biotin-may-interfere-lab-tests-fda-safety-
communication K192815 - Page 2 of 20 Procalcitonin (PCT) C Type of Test: Quantitative, Electrochemiluminescence Immunoassay III Intended Use/Indications for Use: A Intended Use(s): See Indications for Use below. B Indication(s) for Use: Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 –EDTA, K3-EDTA and Li-Heparin). The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers. Used in conjunction with other laboratory findings and clinical assessments, Elecsys BRAHMS PCT is intended for use as follows: • to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock, • to determine the change in PCT level over time as an aid in assessing the cumulative 28-day risk of all-cause mortality for patients diagnosed with severe sepsis or septic shock in the ICU or when obtained in the emergency department or other medical wards prior to ICU admission, • to aid in decision making on antibiotic therapy, for inpatients or patients in the emergency department with suspected or confirmed lower respiratory tract infections (LRTI) – defined as community-acquired pneumonia (CAP), acute bronchitis, and acute exacerbation of chronic obstructive pulmonary disease (AECOPD), • to aid in decision making on antibiotic discontinuation for patients with suspected or confirmed sepsis. C Special Conditions for Use Statement(s): Rx - For Prescription Use Only Warnings and Precautions The Elecsys BRAHMS PCT is not indicated to be used as a stand-alone diagnostic assay and should be used in conjunction with clinical signs and symptoms of infection and other diagnostic evidence. In cases where the laboratory results do not agree with the clinical picture or history, additional tests should be K192815 - Page 3 of 20 performed. Changes in PCT should always be interpreted in the context of the clinical status of the patient and other laboratory results. Decisions regarding antibiotic therapy should NOT be based solely on procalcitonin concentrations. There is no uniformly recognized interpretation of the change in PCT concentration levels for the prediction of mortality, and overall mortality is strongly dependent on many factors, including pre-
existing patient risk factors and clinical course. The need to continue ICU care at Day 4 and other covariates (e.g., age, SOFA score) are also significant predictors of 28 day cumulative mortality risk. Validation of the Elecsys BRAHMS PCT test as an aid in predicting mortality was performed in a study population with an overall 28 day mortality of 22 %. Certain patient characteristics, such as severity of renal failure or insufficiency, may influence procalcitonin values and should be considered as potentially confounding clinical factors when interpreting PCT values. Increased PCT levels may be observed in severe illness such as polytrauma, burns, major surgery, prolonged or cardiogenic shock. PCT levels may not be elevated in patients infected by certain atypical pathogens, such as Chlamydia pneumoniae and Mycoplasma pneumoniae. The safety and performance of PCT-guided therapy for individuals younger than age 17 years, pregnant women, immunocompromised individuals or those on immunomodulatory agents, was not formally analyzed in the supportive clinical trials. D Special Instrument Requirements: The submission demonstrates performance on the cobas e 601 immunoassay analyzer. IV Device/System Characteristics: A Device Description: The Elecsys BRAHMS PCT assay is intended for use with the cobas e immunoassay analyzers, PCT Cal1 and Cal2 reagents, and the PreciControl PCT1 and PCT2 as part of the Elecsys BRAHMS PCT Kit. An optional Procalcitonin CalCheck product is also available. B Principle of Operation: The Elecsys BRAHMS PCT assay is a two-step sandwich immunoassay with streptavidin microparticles, biotinylated antibody and antibody labeled with ruthenium as well as an electrochemiluminescence detection system. Procalcitonin (PCT) in the sample reacts with these labeled antibodies to form a sandwich complex. This complex binds to streptavidin coated magnetic microparticles, which are magnetically captured onto an electrode. Application of voltage to the electrode induces chemiluminescence which is measured by a photomultiplier tube. Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent barcode. Total duration of assay: 18 minutes. K192815 - Page 4 of 20 • 1st incubation: Antigen in the sample (30 μL), a biotinylated monoclonal PCT-specific antibody, and a monoclonal PCT-specific antibody labeled with a ruthenium complex*) react to form a sandwich complex. • 2nd incubation: After addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin. • The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell M. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier. • Results are determined via a calibration curve which is instrument-specifically generated by 2-
point calibration and a master curve provided via the reagent barcode. (*):Tris(2,2'-bipyridyl)ruthenium(II)-complex (Ru(bpy)₃²⁺) C Reagents The reagent working solutions include: Rackpack (kit placed on analyzer) • M: Streptavidin-coated microparticles, • R1: Anti-PCT-Ab~biotin • R2: Anti-PCT-Ab~Ru(bpy)₃²⁺ The following change is proposed to block the interference of biotin with the Elecsys BRAHMS PCT assay: Roche is taking a one-step approach by adding an antibody to bind free biotin in the sample. For the neutralization of free biotin in serum and plasma, Roche developed an antibody which binds to free biotin. The antibodies are specific for free biotin and do not bind to, or interact with, the biotin-linker conjugates. V Substantial Equivalence Information: A Predicate Device Name(s): Elecsys BRAHMS PCT B Predicate 510(k) Number(s): K173927 C Comparison with Predicate(s): Device & Predicate Device(s): K192815 K173927 Device Trade Name Elecsys BRAHMS PCT Same K192815 - Page 5 of 20 Device & Predicate Device(s): K192815 K173927 General Device Characteristic Similarities Intended Use/ Indications for Use Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 –EDTA, K3-EDTA and Li-Heparin). The electrochemiluminescence immunoassay “ECLIA” is intended for use on Elecsys and cobas e immunoassay analyzers. Used in conjunction with other laboratory findings and clinical assessments, Elecsys BRAHMS PCT is intended for use as follows: • to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock, • to determine the change in PCT level over time as an aid in assessing
Measurand: |
idK192815_s0_e2000 | K192815.txt | type of test | Quantitative, Electrochemiluminescence Immunoassay | Page 1 of 20 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY I Background Information: The Elecsys BRAHMS PCT assay has been reformulated to address a 2017 FDA Safety Communication1 alerting the public, health care providers, lab personnel, and lab test developers that biotin can significantly interfere with certain lab tests and cause incorrect test results which may go undetected. A 510(k) Number K192815 B Applicant Roche Diagnostics C Proprietary and Established Names Elecsys BRAHMS PCT D Regulatory Information Product Code(s) Classification Regulation Section Panel PRI Class II 21 CFR 866.3215 - Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis MI - Microbiology II Submission/Device Overview: A Purpose for Submission: The purpose of this Traditional 510(k) Premarket Notification is to obtain FDA clearance for new reagents which have been added to the Elecsys BRAHMS PCT Test System. Additional reagents intended to minimize potentially interfering effects of biotin in a patient specimen have been added to the previously cleared product. B Measurand: 1 https://www.fda.gov/medical-devices/safety-communications/fda-warns-biotin-may-interfere-lab-tests-fda-safety-
communication K192815 - Page 2 of 20 Procalcitonin (PCT) C Type of Test: Quantitative, Electrochemiluminescence Immunoassay III Intended Use/Indications for Use: A Intended Use(s): See Indications for Use below. B Indication(s) for Use: Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 –EDTA, K3-EDTA and Li-Heparin). The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers. Used in conjunction with other laboratory findings and clinical assessments, Elecsys BRAHMS PCT is intended for use as follows: • to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock, • to determine the change in PCT level over time as an aid in assessing the cumulative 28-day risk of all-cause mortality for patients diagnosed with severe sepsis or septic shock in the ICU or when obtained in the emergency department or other medical wards prior to ICU admission, • to aid in decision making on antibiotic therapy, for inpatients or patients in the emergency department with suspected or confirmed lower respiratory tract infections (LRTI) – defined as community-acquired pneumonia (CAP), acute bronchitis, and acute exacerbation of chronic obstructive pulmonary disease (AECOPD), • to aid in decision making on antibiotic discontinuation for patients with suspected or confirmed sepsis. C Special Conditions for Use Statement(s): Rx - For Prescription Use Only Warnings and Precautions The Elecsys BRAHMS PCT is not indicated to be used as a stand-alone diagnostic assay and should be used in conjunction with clinical signs and symptoms of infection and other diagnostic evidence. In cases where the laboratory results do not agree with the clinical picture or history, additional tests should be K192815 - Page 3 of 20 performed. Changes in PCT should always be interpreted in the context of the clinical status of the patient and other laboratory results. Decisions regarding antibiotic therapy should NOT be based solely on procalcitonin concentrations. There is no uniformly recognized interpretation of the change in PCT concentration levels for the prediction of mortality, and overall mortality is strongly dependent on many factors, including pre-
existing patient risk factors and clinical course. The need to continue ICU care at Day 4 and other covariates (e.g., age, SOFA score) are also significant predictors of 28 day cumulative mortality risk. Validation of the Elecsys BRAHMS PCT test as an aid in predicting mortality was performed in a study population with an overall 28 day mortality of 22 %. Certain patient characteristics, such as severity of renal failure or insufficiency, may influence procalcitonin values and should be considered as potentially confounding clinical factors when interpreting PCT values. Increased PCT levels may be observed in severe illness such as polytrauma, burns, major surgery, prolonged or cardiogenic shock. PCT levels may not be elevated in patients infected by certain atypical pathogens, such as Chlamydia pneumoniae and Mycoplasma pneumoniae. The safety and performance of PCT-guided therapy for individuals younger than age 17 years, pregnant women, immunocompromised individuals or those on immunomodulatory agents, was not formally analyzed in the supportive clinical trials. D Special Instrument Requirements: The submission demonstrates performance on the cobas e 601 immunoassay analyzer. IV Device/System Characteristics: A Device Description: The Elecsys BRAHMS PCT assay is intended for use with the cobas e immunoassay analyzers, PCT Cal1 and Cal2 reagents, and the PreciControl PCT1 and PCT2 as part of the Elecsys BRAHMS PCT Kit. An optional Procalcitonin CalCheck product is also available. B Principle of Operation: The Elecsys BRAHMS PCT assay is a two-step sandwich immunoassay with streptavidin microparticles, biotinylated antibody and antibody labeled with ruthenium as well as an electrochemiluminescence detection system. Procalcitonin (PCT) in the sample reacts with these labeled antibodies to form a sandwich complex. This complex binds to streptavidin coated magnetic microparticles, which are magnetically captured onto an electrode. Application of voltage to the electrode induces chemiluminescence which is measured by a photomultiplier tube. Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent barcode. Total duration of assay: 18 minutes. K192815 - Page 4 of 20 • 1st incubation: Antigen in the sample (30 μL), a biotinylated monoclonal PCT-specific antibody, and a monoclonal PCT-specific antibody labeled with a ruthenium complex*) react to form a sandwich complex. • 2nd incubation: After addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin. • The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell M. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier. • Results are determined via a calibration curve which is instrument-specifically generated by 2-
point calibration and a master curve provided via the reagent barcode. (*):Tris(2,2'-bipyridyl)ruthenium(II)-complex (Ru(bpy)₃²⁺) C Reagents The reagent working solutions include: Rackpack (kit placed on analyzer) • M: Streptavidin-coated microparticles, • R1: Anti-PCT-Ab~biotin • R2: Anti-PCT-Ab~Ru(bpy)₃²⁺ The following change is proposed to block the interference of biotin with the Elecsys BRAHMS PCT assay: Roche is taking a one-step approach by adding an antibody to bind free biotin in the sample. For the neutralization of free biotin in serum and plasma, Roche developed an antibody which binds to free biotin. The antibodies are specific for free biotin and do not bind to, or interact with, the biotin-linker conjugates. V Substantial Equivalence Information: A Predicate Device Name(s): Elecsys BRAHMS PCT B Predicate 510(k) Number(s): K173927 C Comparison with Predicate(s): Device & Predicate Device(s): K192815 K173927 Device Trade Name Elecsys BRAHMS PCT Same K192815 - Page 5 of 20 Device & Predicate Device(s): K192815 K173927 General Device Characteristic Similarities Intended Use/ Indications for Use Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 –EDTA, K3-EDTA and Li-Heparin). The electrochemiluminescence immunoassay “ECLIA” is intended for use on Elecsys and cobas e immunoassay analyzers. Used in conjunction with other laboratory findings and clinical assessments, Elecsys BRAHMS PCT is intended for use as follows: • to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock, • to determine the change in PCT level over time as an aid in assessing
Type of test: |
idK192815_s0_e2000 | K192815.txt | classification | Class II | - Page 1 of 20 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY I Background Information: The Elecsys BRAHMS PCT assay has been reformulated to address a 2017 FDA Safety Communication1 alerting the public, health care providers, lab personnel, and lab test developers that biotin can significantly interfere with certain lab tests and cause incorrect test results which may go undetected. A 510(k) Number K192815 B Applicant Roche Diagnostics C Proprietary and Established Names Elecsys BRAHMS PCT D Regulatory Information Product Code(s) Classification Regulation Section Panel PRI Class II 21 CFR 866.3215 - Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis MI - Microbiology II Submission/Device Overview: A Purpose for Submission: The purpose of this Traditional 510(k) Premarket Notification is to obtain FDA clearance for new reagents which have been added to the Elecsys BRAHMS PCT Test System. Additional reagents intended to minimize potentially interfering effects of biotin in a patient specimen have been added to the previously cleared product. B Measurand: 1 https://www.fda.gov/medical-devices/safety-communications/fda-warns-biotin-may-interfere-lab-tests-fda-safety-
communication K192815 - Page 2 of 20 Procalcitonin (PCT) C Type of Test: Quantitative, Electrochemiluminescence Immunoassay III Intended Use/Indications for Use: A Intended Use(s): See Indications for Use below. B Indication(s) for Use: Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 –EDTA, K3-EDTA and Li-Heparin). The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers. Used in conjunction with other laboratory findings and clinical assessments, Elecsys BRAHMS PCT is intended for use as follows: • to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock, • to determine the change in PCT level over time as an aid in assessing the cumulative 28-day risk of all-cause mortality for patients diagnosed with severe sepsis or septic shock in the ICU or when obtained in the emergency department or other medical wards prior to ICU admission, • to aid in decision making on antibiotic therapy, for inpatients or patients in the emergency department with suspected or confirmed lower respiratory tract infections (LRTI) – defined as community-acquired pneumonia (CAP), acute bronchitis, and acute exacerbation of chronic obstructive pulmonary disease (AECOPD), • to aid in decision making on antibiotic discontinuation for patients with suspected or confirmed sepsis. C Special Conditions for Use Statement(s): Rx - For Prescription Use Only Warnings and Precautions The Elecsys BRAHMS PCT is not indicated to be used as a stand-alone diagnostic assay and should be used in conjunction with clinical signs and symptoms of infection and other diagnostic evidence. In cases where the laboratory results do not agree with the clinical picture or history, additional tests should be K192815 - Page 3 of 20 performed. Changes in PCT should always be interpreted in the context of the clinical status of the patient and other laboratory results. Decisions regarding antibiotic therapy should NOT be based solely on procalcitonin concentrations. There is no uniformly recognized interpretation of the change in PCT concentration levels for the prediction of mortality, and overall mortality is strongly dependent on many factors, including pre-
existing patient risk factors and clinical course. The need to continue ICU care at Day 4 and other covariates (e.g., age, SOFA score) are also significant predictors of 28 day cumulative mortality risk. Validation of the Elecsys BRAHMS PCT test as an aid in predicting mortality was performed in a study population with an overall 28 day mortality of 22 %. Certain patient characteristics, such as severity of renal failure or insufficiency, may influence procalcitonin values and should be considered as potentially confounding clinical factors when interpreting PCT values. Increased PCT levels may be observed in severe illness such as polytrauma, burns, major surgery, prolonged or cardiogenic shock. PCT levels may not be elevated in patients infected by certain atypical pathogens, such as Chlamydia pneumoniae and Mycoplasma pneumoniae. The safety and performance of PCT-guided therapy for individuals younger than age 17 years, pregnant women, immunocompromised individuals or those on immunomodulatory agents, was not formally analyzed in the supportive clinical trials. D Special Instrument Requirements: The submission demonstrates performance on the cobas e 601 immunoassay analyzer. IV Device/System Characteristics: A Device Description: The Elecsys BRAHMS PCT assay is intended for use with the cobas e immunoassay analyzers, PCT Cal1 and Cal2 reagents, and the PreciControl PCT1 and PCT2 as part of the Elecsys BRAHMS PCT Kit. An optional Procalcitonin CalCheck product is also available. B Principle of Operation: The Elecsys BRAHMS PCT assay is a two-step sandwich immunoassay with streptavidin microparticles, biotinylated antibody and antibody labeled with ruthenium as well as an electrochemiluminescence detection system. Procalcitonin (PCT) in the sample reacts with these labeled antibodies to form a sandwich complex. This complex binds to streptavidin coated magnetic microparticles, which are magnetically captured onto an electrode. Application of voltage to the electrode induces chemiluminescence which is measured by a photomultiplier tube. Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent barcode. Total duration of assay: 18 minutes. K192815 - Page 4 of 20 • 1st incubation: Antigen in the sample (30 μL), a biotinylated monoclonal PCT-specific antibody, and a monoclonal PCT-specific antibody labeled with a ruthenium complex*) react to form a sandwich complex. • 2nd incubation: After addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin. • The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell M. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier. • Results are determined via a calibration curve which is instrument-specifically generated by 2-
point calibration and a master curve provided via the reagent barcode. (*):Tris(2,2'-bipyridyl)ruthenium(II)-complex (Ru(bpy)₃²⁺) C Reagents The reagent working solutions include: Rackpack (kit placed on analyzer) • M: Streptavidin-coated microparticles, • R1: Anti-PCT-Ab~biotin • R2: Anti-PCT-Ab~Ru(bpy)₃²⁺ The following change is proposed to block the interference of biotin with the Elecsys BRAHMS PCT assay: Roche is taking a one-step approach by adding an antibody to bind free biotin in the sample. For the neutralization of free biotin in serum and plasma, Roche developed an antibody which binds to free biotin. The antibodies are specific for free biotin and do not bind to, or interact with, the biotin-linker conjugates. V Substantial Equivalence Information: A Predicate Device Name(s): Elecsys BRAHMS PCT B Predicate 510(k) Number(s): K173927 C Comparison with Predicate(s): Device & Predicate Device(s): K192815 K173927 Device Trade Name Elecsys BRAHMS PCT Same K192815 - Page 5 of 20 Device & Predicate Device(s): K192815 K173927 General Device Characteristic Similarities Intended Use/ Indications for Use Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 –EDTA, K3-EDTA and Li-Heparin). The electrochemiluminescence immunoassay “ECLIA” is intended for use on Elecsys and cobas e immunoassay analyzers. Used in conjunction with other laboratory findings and clinical assessments, Elecsys BRAHMS PCT is intended for use as follows: • to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock, • to determine the change in PCT level over time as an aid in assessing
Classification: |
idK192815_s0_e2000 | K192815.txt | product code | PRI | - Page 1 of 20 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY I Background Information: The Elecsys BRAHMS PCT assay has been reformulated to address a 2017 FDA Safety Communication1 alerting the public, health care providers, lab personnel, and lab test developers that biotin can significantly interfere with certain lab tests and cause incorrect test results which may go undetected. A 510(k) Number K192815 B Applicant Roche Diagnostics C Proprietary and Established Names Elecsys BRAHMS PCT D Regulatory Information Product Code(s) Classification Regulation Section Panel PRI Class II 21 CFR 866.3215 - Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis MI - Microbiology II Submission/Device Overview: A Purpose for Submission: The purpose of this Traditional 510(k) Premarket Notification is to obtain FDA clearance for new reagents which have been added to the Elecsys BRAHMS PCT Test System. Additional reagents intended to minimize potentially interfering effects of biotin in a patient specimen have been added to the previously cleared product. B Measurand: 1 https://www.fda.gov/medical-devices/safety-communications/fda-warns-biotin-may-interfere-lab-tests-fda-safety-
communication K192815 - Page 2 of 20 Procalcitonin (PCT) C Type of Test: Quantitative, Electrochemiluminescence Immunoassay III Intended Use/Indications for Use: A Intended Use(s): See Indications for Use below. B Indication(s) for Use: Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 –EDTA, K3-EDTA and Li-Heparin). The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers. Used in conjunction with other laboratory findings and clinical assessments, Elecsys BRAHMS PCT is intended for use as follows: • to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock, • to determine the change in PCT level over time as an aid in assessing the cumulative 28-day risk of all-cause mortality for patients diagnosed with severe sepsis or septic shock in the ICU or when obtained in the emergency department or other medical wards prior to ICU admission, • to aid in decision making on antibiotic therapy, for inpatients or patients in the emergency department with suspected or confirmed lower respiratory tract infections (LRTI) – defined as community-acquired pneumonia (CAP), acute bronchitis, and acute exacerbation of chronic obstructive pulmonary disease (AECOPD), • to aid in decision making on antibiotic discontinuation for patients with suspected or confirmed sepsis. C Special Conditions for Use Statement(s): Rx - For Prescription Use Only Warnings and Precautions The Elecsys BRAHMS PCT is not indicated to be used as a stand-alone diagnostic assay and should be used in conjunction with clinical signs and symptoms of infection and other diagnostic evidence. In cases where the laboratory results do not agree with the clinical picture or history, additional tests should be K192815 - Page 3 of 20 performed. Changes in PCT should always be interpreted in the context of the clinical status of the patient and other laboratory results. Decisions regarding antibiotic therapy should NOT be based solely on procalcitonin concentrations. There is no uniformly recognized interpretation of the change in PCT concentration levels for the prediction of mortality, and overall mortality is strongly dependent on many factors, including pre-
existing patient risk factors and clinical course. The need to continue ICU care at Day 4 and other covariates (e.g., age, SOFA score) are also significant predictors of 28 day cumulative mortality risk. Validation of the Elecsys BRAHMS PCT test as an aid in predicting mortality was performed in a study population with an overall 28 day mortality of 22 %. Certain patient characteristics, such as severity of renal failure or insufficiency, may influence procalcitonin values and should be considered as potentially confounding clinical factors when interpreting PCT values. Increased PCT levels may be observed in severe illness such as polytrauma, burns, major surgery, prolonged or cardiogenic shock. PCT levels may not be elevated in patients infected by certain atypical pathogens, such as Chlamydia pneumoniae and Mycoplasma pneumoniae. The safety and performance of PCT-guided therapy for individuals younger than age 17 years, pregnant women, immunocompromised individuals or those on immunomodulatory agents, was not formally analyzed in the supportive clinical trials. D Special Instrument Requirements: The submission demonstrates performance on the cobas e 601 immunoassay analyzer. IV Device/System Characteristics: A Device Description: The Elecsys BRAHMS PCT assay is intended for use with the cobas e immunoassay analyzers, PCT Cal1 and Cal2 reagents, and the PreciControl PCT1 and PCT2 as part of the Elecsys BRAHMS PCT Kit. An optional Procalcitonin CalCheck product is also available. B Principle of Operation: The Elecsys BRAHMS PCT assay is a two-step sandwich immunoassay with streptavidin microparticles, biotinylated antibody and antibody labeled with ruthenium as well as an electrochemiluminescence detection system. Procalcitonin (PCT) in the sample reacts with these labeled antibodies to form a sandwich complex. This complex binds to streptavidin coated magnetic microparticles, which are magnetically captured onto an electrode. Application of voltage to the electrode induces chemiluminescence which is measured by a photomultiplier tube. Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent barcode. Total duration of assay: 18 minutes. K192815 - Page 4 of 20 • 1st incubation: Antigen in the sample (30 μL), a biotinylated monoclonal PCT-specific antibody, and a monoclonal PCT-specific antibody labeled with a ruthenium complex*) react to form a sandwich complex. • 2nd incubation: After addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin. • The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell M. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier. • Results are determined via a calibration curve which is instrument-specifically generated by 2-
point calibration and a master curve provided via the reagent barcode. (*):Tris(2,2'-bipyridyl)ruthenium(II)-complex (Ru(bpy)₃²⁺) C Reagents The reagent working solutions include: Rackpack (kit placed on analyzer) • M: Streptavidin-coated microparticles, • R1: Anti-PCT-Ab~biotin • R2: Anti-PCT-Ab~Ru(bpy)₃²⁺ The following change is proposed to block the interference of biotin with the Elecsys BRAHMS PCT assay: Roche is taking a one-step approach by adding an antibody to bind free biotin in the sample. For the neutralization of free biotin in serum and plasma, Roche developed an antibody which binds to free biotin. The antibodies are specific for free biotin and do not bind to, or interact with, the biotin-linker conjugates. V Substantial Equivalence Information: A Predicate Device Name(s): Elecsys BRAHMS PCT B Predicate 510(k) Number(s): K173927 C Comparison with Predicate(s): Device & Predicate Device(s): K192815 K173927 Device Trade Name Elecsys BRAHMS PCT Same K192815 - Page 5 of 20 Device & Predicate Device(s): K192815 K173927 General Device Characteristic Similarities Intended Use/ Indications for Use Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 –EDTA, K3-EDTA and Li-Heparin). The electrochemiluminescence immunoassay “ECLIA” is intended for use on Elecsys and cobas e immunoassay analyzers. Used in conjunction with other laboratory findings and clinical assessments, Elecsys BRAHMS PCT is intended for use as follows: • to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock, • to determine the change in PCT level over time as an aid in assessing
Product code: |
idK192815_s0_e2000 | K192815.txt | panel | MI - Microbiology | 15 - Page 1 of 20 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY I Background Information: The Elecsys BRAHMS PCT assay has been reformulated to address a 2017 FDA Safety Communication1 alerting the public, health care providers, lab personnel, and lab test developers that biotin can significantly interfere with certain lab tests and cause incorrect test results which may go undetected. A 510(k) Number K192815 B Applicant Roche Diagnostics C Proprietary and Established Names Elecsys BRAHMS PCT D Regulatory Information Product Code(s) Classification Regulation Section Panel PRI Class II 21 CFR 866.3215 - Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis MI - Microbiology II Submission/Device Overview: A Purpose for Submission: The purpose of this Traditional 510(k) Premarket Notification is to obtain FDA clearance for new reagents which have been added to the Elecsys BRAHMS PCT Test System. Additional reagents intended to minimize potentially interfering effects of biotin in a patient specimen have been added to the previously cleared product. B Measurand: 1 https://www.fda.gov/medical-devices/safety-communications/fda-warns-biotin-may-interfere-lab-tests-fda-safety-
communication K192815 - Page 2 of 20 Procalcitonin (PCT) C Type of Test: Quantitative, Electrochemiluminescence Immunoassay III Intended Use/Indications for Use: A Intended Use(s): See Indications for Use below. B Indication(s) for Use: Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 –EDTA, K3-EDTA and Li-Heparin). The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers. Used in conjunction with other laboratory findings and clinical assessments, Elecsys BRAHMS PCT is intended for use as follows: • to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock, • to determine the change in PCT level over time as an aid in assessing the cumulative 28-day risk of all-cause mortality for patients diagnosed with severe sepsis or septic shock in the ICU or when obtained in the emergency department or other medical wards prior to ICU admission, • to aid in decision making on antibiotic therapy, for inpatients or patients in the emergency department with suspected or confirmed lower respiratory tract infections (LRTI) – defined as community-acquired pneumonia (CAP), acute bronchitis, and acute exacerbation of chronic obstructive pulmonary disease (AECOPD), • to aid in decision making on antibiotic discontinuation for patients with suspected or confirmed sepsis. C Special Conditions for Use Statement(s): Rx - For Prescription Use Only Warnings and Precautions The Elecsys BRAHMS PCT is not indicated to be used as a stand-alone diagnostic assay and should be used in conjunction with clinical signs and symptoms of infection and other diagnostic evidence. In cases where the laboratory results do not agree with the clinical picture or history, additional tests should be K192815 - Page 3 of 20 performed. Changes in PCT should always be interpreted in the context of the clinical status of the patient and other laboratory results. Decisions regarding antibiotic therapy should NOT be based solely on procalcitonin concentrations. There is no uniformly recognized interpretation of the change in PCT concentration levels for the prediction of mortality, and overall mortality is strongly dependent on many factors, including pre-
existing patient risk factors and clinical course. The need to continue ICU care at Day 4 and other covariates (e.g., age, SOFA score) are also significant predictors of 28 day cumulative mortality risk. Validation of the Elecsys BRAHMS PCT test as an aid in predicting mortality was performed in a study population with an overall 28 day mortality of 22 %. Certain patient characteristics, such as severity of renal failure or insufficiency, may influence procalcitonin values and should be considered as potentially confounding clinical factors when interpreting PCT values. Increased PCT levels may be observed in severe illness such as polytrauma, burns, major surgery, prolonged or cardiogenic shock. PCT levels may not be elevated in patients infected by certain atypical pathogens, such as Chlamydia pneumoniae and Mycoplasma pneumoniae. The safety and performance of PCT-guided therapy for individuals younger than age 17 years, pregnant women, immunocompromised individuals or those on immunomodulatory agents, was not formally analyzed in the supportive clinical trials. D Special Instrument Requirements: The submission demonstrates performance on the cobas e 601 immunoassay analyzer. IV Device/System Characteristics: A Device Description: The Elecsys BRAHMS PCT assay is intended for use with the cobas e immunoassay analyzers, PCT Cal1 and Cal2 reagents, and the PreciControl PCT1 and PCT2 as part of the Elecsys BRAHMS PCT Kit. An optional Procalcitonin CalCheck product is also available. B Principle of Operation: The Elecsys BRAHMS PCT assay is a two-step sandwich immunoassay with streptavidin microparticles, biotinylated antibody and antibody labeled with ruthenium as well as an electrochemiluminescence detection system. Procalcitonin (PCT) in the sample reacts with these labeled antibodies to form a sandwich complex. This complex binds to streptavidin coated magnetic microparticles, which are magnetically captured onto an electrode. Application of voltage to the electrode induces chemiluminescence which is measured by a photomultiplier tube. Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent barcode. Total duration of assay: 18 minutes. K192815 - Page 4 of 20 • 1st incubation: Antigen in the sample (30 μL), a biotinylated monoclonal PCT-specific antibody, and a monoclonal PCT-specific antibody labeled with a ruthenium complex*) react to form a sandwich complex. • 2nd incubation: After addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin. • The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell M. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier. • Results are determined via a calibration curve which is instrument-specifically generated by 2-
point calibration and a master curve provided via the reagent barcode. (*):Tris(2,2'-bipyridyl)ruthenium(II)-complex (Ru(bpy)₃²⁺) C Reagents The reagent working solutions include: Rackpack (kit placed on analyzer) • M: Streptavidin-coated microparticles, • R1: Anti-PCT-Ab~biotin • R2: Anti-PCT-Ab~Ru(bpy)₃²⁺ The following change is proposed to block the interference of biotin with the Elecsys BRAHMS PCT assay: Roche is taking a one-step approach by adding an antibody to bind free biotin in the sample. For the neutralization of free biotin in serum and plasma, Roche developed an antibody which binds to free biotin. The antibodies are specific for free biotin and do not bind to, or interact with, the biotin-linker conjugates. V Substantial Equivalence Information: A Predicate Device Name(s): Elecsys BRAHMS PCT B Predicate 510(k) Number(s): K173927 C Comparison with Predicate(s): Device & Predicate Device(s): K192815 K173927 Device Trade Name Elecsys BRAHMS PCT Same K192815 - Page 5 of 20 Device & Predicate Device(s): K192815 K173927 General Device Characteristic Similarities Intended Use/ Indications for Use Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 –EDTA, K3-EDTA and Li-Heparin). The electrochemiluminescence immunoassay “ECLIA” is intended for use on Elecsys and cobas e immunoassay analyzers. Used in conjunction with other laboratory findings and clinical assessments, Elecsys BRAHMS PCT is intended for use as follows: • to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock, • to determine the change in PCT level over time as an aid in assessing
Panel: |
idK192815_s0_e2000 | K192815.txt | intended use | See Indications for Use below. | Page 1 of 20 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY I Background Information: The Elecsys BRAHMS PCT assay has been reformulated to address a 2017 FDA Safety Communication1 alerting the public, health care providers, lab personnel, and lab test developers that biotin can significantly interfere with certain lab tests and cause incorrect test results which may go undetected. A 510(k) Number K192815 B Applicant Roche Diagnostics C Proprietary and Established Names Elecsys BRAHMS PCT D Regulatory Information Product Code(s) Classification Regulation Section Panel PRI Class II 21 CFR 866.3215 - Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis MI - Microbiology II Submission/Device Overview: A Purpose for Submission: The purpose of this Traditional 510(k) Premarket Notification is to obtain FDA clearance for new reagents which have been added to the Elecsys BRAHMS PCT Test System. Additional reagents intended to minimize potentially interfering effects of biotin in a patient specimen have been added to the previously cleared product. B Measurand: 1 https://www.fda.gov/medical-devices/safety-communications/fda-warns-biotin-may-interfere-lab-tests-fda-safety-
communication K192815 - Page 2 of 20 Procalcitonin (PCT) C Type of Test: Quantitative, Electrochemiluminescence Immunoassay III Intended Use/Indications for Use: A Intended Use(s): See Indications for Use below. B Indication(s) for Use: Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 –EDTA, K3-EDTA and Li-Heparin). The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers. Used in conjunction with other laboratory findings and clinical assessments, Elecsys BRAHMS PCT is intended for use as follows: • to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock, • to determine the change in PCT level over time as an aid in assessing the cumulative 28-day risk of all-cause mortality for patients diagnosed with severe sepsis or septic shock in the ICU or when obtained in the emergency department or other medical wards prior to ICU admission, • to aid in decision making on antibiotic therapy, for inpatients or patients in the emergency department with suspected or confirmed lower respiratory tract infections (LRTI) – defined as community-acquired pneumonia (CAP), acute bronchitis, and acute exacerbation of chronic obstructive pulmonary disease (AECOPD), • to aid in decision making on antibiotic discontinuation for patients with suspected or confirmed sepsis. C Special Conditions for Use Statement(s): Rx - For Prescription Use Only Warnings and Precautions The Elecsys BRAHMS PCT is not indicated to be used as a stand-alone diagnostic assay and should be used in conjunction with clinical signs and symptoms of infection and other diagnostic evidence. In cases where the laboratory results do not agree with the clinical picture or history, additional tests should be K192815 - Page 3 of 20 performed. Changes in PCT should always be interpreted in the context of the clinical status of the patient and other laboratory results. Decisions regarding antibiotic therapy should NOT be based solely on procalcitonin concentrations. There is no uniformly recognized interpretation of the change in PCT concentration levels for the prediction of mortality, and overall mortality is strongly dependent on many factors, including pre-
existing patient risk factors and clinical course. The need to continue ICU care at Day 4 and other covariates (e.g., age, SOFA score) are also significant predictors of 28 day cumulative mortality risk. Validation of the Elecsys BRAHMS PCT test as an aid in predicting mortality was performed in a study population with an overall 28 day mortality of 22 %. Certain patient characteristics, such as severity of renal failure or insufficiency, may influence procalcitonin values and should be considered as potentially confounding clinical factors when interpreting PCT values. Increased PCT levels may be observed in severe illness such as polytrauma, burns, major surgery, prolonged or cardiogenic shock. PCT levels may not be elevated in patients infected by certain atypical pathogens, such as Chlamydia pneumoniae and Mycoplasma pneumoniae. The safety and performance of PCT-guided therapy for individuals younger than age 17 years, pregnant women, immunocompromised individuals or those on immunomodulatory agents, was not formally analyzed in the supportive clinical trials. D Special Instrument Requirements: The submission demonstrates performance on the cobas e 601 immunoassay analyzer. IV Device/System Characteristics: A Device Description: The Elecsys BRAHMS PCT assay is intended for use with the cobas e immunoassay analyzers, PCT Cal1 and Cal2 reagents, and the PreciControl PCT1 and PCT2 as part of the Elecsys BRAHMS PCT Kit. An optional Procalcitonin CalCheck product is also available. B Principle of Operation: The Elecsys BRAHMS PCT assay is a two-step sandwich immunoassay with streptavidin microparticles, biotinylated antibody and antibody labeled with ruthenium as well as an electrochemiluminescence detection system. Procalcitonin (PCT) in the sample reacts with these labeled antibodies to form a sandwich complex. This complex binds to streptavidin coated magnetic microparticles, which are magnetically captured onto an electrode. Application of voltage to the electrode induces chemiluminescence which is measured by a photomultiplier tube. Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent barcode. Total duration of assay: 18 minutes. K192815 - Page 4 of 20 • 1st incubation: Antigen in the sample (30 μL), a biotinylated monoclonal PCT-specific antibody, and a monoclonal PCT-specific antibody labeled with a ruthenium complex*) react to form a sandwich complex. • 2nd incubation: After addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin. • The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell M. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier. • Results are determined via a calibration curve which is instrument-specifically generated by 2-
point calibration and a master curve provided via the reagent barcode. (*):Tris(2,2'-bipyridyl)ruthenium(II)-complex (Ru(bpy)₃²⁺) C Reagents The reagent working solutions include: Rackpack (kit placed on analyzer) • M: Streptavidin-coated microparticles, • R1: Anti-PCT-Ab~biotin • R2: Anti-PCT-Ab~Ru(bpy)₃²⁺ The following change is proposed to block the interference of biotin with the Elecsys BRAHMS PCT assay: Roche is taking a one-step approach by adding an antibody to bind free biotin in the sample. For the neutralization of free biotin in serum and plasma, Roche developed an antibody which binds to free biotin. The antibodies are specific for free biotin and do not bind to, or interact with, the biotin-linker conjugates. V Substantial Equivalence Information: A Predicate Device Name(s): Elecsys BRAHMS PCT B Predicate 510(k) Number(s): K173927 C Comparison with Predicate(s): Device & Predicate Device(s): K192815 K173927 Device Trade Name Elecsys BRAHMS PCT Same K192815 - Page 5 of 20 Device & Predicate Device(s): K192815 K173927 General Device Characteristic Similarities Intended Use/ Indications for Use Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 –EDTA, K3-EDTA and Li-Heparin). The electrochemiluminescence immunoassay “ECLIA” is intended for use on Elecsys and cobas e immunoassay analyzers. Used in conjunction with other laboratory findings and clinical assessments, Elecsys BRAHMS PCT is intended for use as follows: • to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock, • to determine the change in PCT level over time as an aid in assessing
Intended use: |
idK192815_s0_e2000 | K192815.txt | predicate device name | Elecsys BRAHMS PCT | 1 of 20 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY I Background Information: The Elecsys BRAHMS PCT assay has been reformulated to address a 2017 FDA Safety Communication1 alerting the public, health care providers, lab personnel, and lab test developers that biotin can significantly interfere with certain lab tests and cause incorrect test results which may go undetected. A 510(k) Number K192815 B Applicant Roche Diagnostics C Proprietary and Established Names Elecsys BRAHMS PCT D Regulatory Information Product Code(s) Classification Regulation Section Panel PRI Class II 21 CFR 866.3215 - Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis MI - Microbiology II Submission/Device Overview: A Purpose for Submission: The purpose of this Traditional 510(k) Premarket Notification is to obtain FDA clearance for new reagents which have been added to the Elecsys BRAHMS PCT Test System. Additional reagents intended to minimize potentially interfering effects of biotin in a patient specimen have been added to the previously cleared product. B Measurand: 1 https://www.fda.gov/medical-devices/safety-communications/fda-warns-biotin-may-interfere-lab-tests-fda-safety-
communication K192815 - Page 2 of 20 Procalcitonin (PCT) C Type of Test: Quantitative, Electrochemiluminescence Immunoassay III Intended Use/Indications for Use: A Intended Use(s): See Indications for Use below. B Indication(s) for Use: Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 –EDTA, K3-EDTA and Li-Heparin). The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers. Used in conjunction with other laboratory findings and clinical assessments, Elecsys BRAHMS PCT is intended for use as follows: • to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock, • to determine the change in PCT level over time as an aid in assessing the cumulative 28-day risk of all-cause mortality for patients diagnosed with severe sepsis or septic shock in the ICU or when obtained in the emergency department or other medical wards prior to ICU admission, • to aid in decision making on antibiotic therapy, for inpatients or patients in the emergency department with suspected or confirmed lower respiratory tract infections (LRTI) – defined as community-acquired pneumonia (CAP), acute bronchitis, and acute exacerbation of chronic obstructive pulmonary disease (AECOPD), • to aid in decision making on antibiotic discontinuation for patients with suspected or confirmed sepsis. C Special Conditions for Use Statement(s): Rx - For Prescription Use Only Warnings and Precautions The Elecsys BRAHMS PCT is not indicated to be used as a stand-alone diagnostic assay and should be used in conjunction with clinical signs and symptoms of infection and other diagnostic evidence. In cases where the laboratory results do not agree with the clinical picture or history, additional tests should be K192815 - Page 3 of 20 performed. Changes in PCT should always be interpreted in the context of the clinical status of the patient and other laboratory results. Decisions regarding antibiotic therapy should NOT be based solely on procalcitonin concentrations. There is no uniformly recognized interpretation of the change in PCT concentration levels for the prediction of mortality, and overall mortality is strongly dependent on many factors, including pre-
existing patient risk factors and clinical course. The need to continue ICU care at Day 4 and other covariates (e.g., age, SOFA score) are also significant predictors of 28 day cumulative mortality risk. Validation of the Elecsys BRAHMS PCT test as an aid in predicting mortality was performed in a study population with an overall 28 day mortality of 22 %. Certain patient characteristics, such as severity of renal failure or insufficiency, may influence procalcitonin values and should be considered as potentially confounding clinical factors when interpreting PCT values. Increased PCT levels may be observed in severe illness such as polytrauma, burns, major surgery, prolonged or cardiogenic shock. PCT levels may not be elevated in patients infected by certain atypical pathogens, such as Chlamydia pneumoniae and Mycoplasma pneumoniae. The safety and performance of PCT-guided therapy for individuals younger than age 17 years, pregnant women, immunocompromised individuals or those on immunomodulatory agents, was not formally analyzed in the supportive clinical trials. D Special Instrument Requirements: The submission demonstrates performance on the cobas e 601 immunoassay analyzer. IV Device/System Characteristics: A Device Description: The Elecsys BRAHMS PCT assay is intended for use with the cobas e immunoassay analyzers, PCT Cal1 and Cal2 reagents, and the PreciControl PCT1 and PCT2 as part of the Elecsys BRAHMS PCT Kit. An optional Procalcitonin CalCheck product is also available. B Principle of Operation: The Elecsys BRAHMS PCT assay is a two-step sandwich immunoassay with streptavidin microparticles, biotinylated antibody and antibody labeled with ruthenium as well as an electrochemiluminescence detection system. Procalcitonin (PCT) in the sample reacts with these labeled antibodies to form a sandwich complex. This complex binds to streptavidin coated magnetic microparticles, which are magnetically captured onto an electrode. Application of voltage to the electrode induces chemiluminescence which is measured by a photomultiplier tube. Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent barcode. Total duration of assay: 18 minutes. K192815 - Page 4 of 20 • 1st incubation: Antigen in the sample (30 μL), a biotinylated monoclonal PCT-specific antibody, and a monoclonal PCT-specific antibody labeled with a ruthenium complex*) react to form a sandwich complex. • 2nd incubation: After addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin. • The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell M. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier. • Results are determined via a calibration curve which is instrument-specifically generated by 2-
point calibration and a master curve provided via the reagent barcode. (*):Tris(2,2'-bipyridyl)ruthenium(II)-complex (Ru(bpy)₃²⁺) C Reagents The reagent working solutions include: Rackpack (kit placed on analyzer) • M: Streptavidin-coated microparticles, • R1: Anti-PCT-Ab~biotin • R2: Anti-PCT-Ab~Ru(bpy)₃²⁺ The following change is proposed to block the interference of biotin with the Elecsys BRAHMS PCT assay: Roche is taking a one-step approach by adding an antibody to bind free biotin in the sample. For the neutralization of free biotin in serum and plasma, Roche developed an antibody which binds to free biotin. The antibodies are specific for free biotin and do not bind to, or interact with, the biotin-linker conjugates. V Substantial Equivalence Information: A Predicate Device Name(s): Elecsys BRAHMS PCT B Predicate 510(k) Number(s): K173927 C Comparison with Predicate(s): Device & Predicate Device(s): K192815 K173927 Device Trade Name Elecsys BRAHMS PCT Same K192815 - Page 5 of 20 Device & Predicate Device(s): K192815 K173927 General Device Characteristic Similarities Intended Use/ Indications for Use Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 –EDTA, K3-EDTA and Li-Heparin). The electrochemiluminescence immunoassay “ECLIA” is intended for use on Elecsys and cobas e immunoassay analyzers. Used in conjunction with other laboratory findings and clinical assessments, Elecsys BRAHMS PCT is intended for use as follows: • to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock, • to determine the change in PCT level over time as an aid in assessing
Predicate device name: |
idK192815_s0_e2000 | K192815.txt | applicant | Roche Diagnostics | - Page 1 of 20 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY I Background Information: The Elecsys BRAHMS PCT assay has been reformulated to address a 2017 FDA Safety Communication1 alerting the public, health care providers, lab personnel, and lab test developers that biotin can significantly interfere with certain lab tests and cause incorrect test results which may go undetected. A 510(k) Number K192815 B Applicant Roche Diagnostics C Proprietary and Established Names Elecsys BRAHMS PCT D Regulatory Information Product Code(s) Classification Regulation Section Panel PRI Class II 21 CFR 866.3215 - Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis MI - Microbiology II Submission/Device Overview: A Purpose for Submission: The purpose of this Traditional 510(k) Premarket Notification is to obtain FDA clearance for new reagents which have been added to the Elecsys BRAHMS PCT Test System. Additional reagents intended to minimize potentially interfering effects of biotin in a patient specimen have been added to the previously cleared product. B Measurand: 1 https://www.fda.gov/medical-devices/safety-communications/fda-warns-biotin-may-interfere-lab-tests-fda-safety-
communication K192815 - Page 2 of 20 Procalcitonin (PCT) C Type of Test: Quantitative, Electrochemiluminescence Immunoassay III Intended Use/Indications for Use: A Intended Use(s): See Indications for Use below. B Indication(s) for Use: Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 –EDTA, K3-EDTA and Li-Heparin). The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers. Used in conjunction with other laboratory findings and clinical assessments, Elecsys BRAHMS PCT is intended for use as follows: • to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock, • to determine the change in PCT level over time as an aid in assessing the cumulative 28-day risk of all-cause mortality for patients diagnosed with severe sepsis or septic shock in the ICU or when obtained in the emergency department or other medical wards prior to ICU admission, • to aid in decision making on antibiotic therapy, for inpatients or patients in the emergency department with suspected or confirmed lower respiratory tract infections (LRTI) – defined as community-acquired pneumonia (CAP), acute bronchitis, and acute exacerbation of chronic obstructive pulmonary disease (AECOPD), • to aid in decision making on antibiotic discontinuation for patients with suspected or confirmed sepsis. C Special Conditions for Use Statement(s): Rx - For Prescription Use Only Warnings and Precautions The Elecsys BRAHMS PCT is not indicated to be used as a stand-alone diagnostic assay and should be used in conjunction with clinical signs and symptoms of infection and other diagnostic evidence. In cases where the laboratory results do not agree with the clinical picture or history, additional tests should be K192815 - Page 3 of 20 performed. Changes in PCT should always be interpreted in the context of the clinical status of the patient and other laboratory results. Decisions regarding antibiotic therapy should NOT be based solely on procalcitonin concentrations. There is no uniformly recognized interpretation of the change in PCT concentration levels for the prediction of mortality, and overall mortality is strongly dependent on many factors, including pre-
existing patient risk factors and clinical course. The need to continue ICU care at Day 4 and other covariates (e.g., age, SOFA score) are also significant predictors of 28 day cumulative mortality risk. Validation of the Elecsys BRAHMS PCT test as an aid in predicting mortality was performed in a study population with an overall 28 day mortality of 22 %. Certain patient characteristics, such as severity of renal failure or insufficiency, may influence procalcitonin values and should be considered as potentially confounding clinical factors when interpreting PCT values. Increased PCT levels may be observed in severe illness such as polytrauma, burns, major surgery, prolonged or cardiogenic shock. PCT levels may not be elevated in patients infected by certain atypical pathogens, such as Chlamydia pneumoniae and Mycoplasma pneumoniae. The safety and performance of PCT-guided therapy for individuals younger than age 17 years, pregnant women, immunocompromised individuals or those on immunomodulatory agents, was not formally analyzed in the supportive clinical trials. D Special Instrument Requirements: The submission demonstrates performance on the cobas e 601 immunoassay analyzer. IV Device/System Characteristics: A Device Description: The Elecsys BRAHMS PCT assay is intended for use with the cobas e immunoassay analyzers, PCT Cal1 and Cal2 reagents, and the PreciControl PCT1 and PCT2 as part of the Elecsys BRAHMS PCT Kit. An optional Procalcitonin CalCheck product is also available. B Principle of Operation: The Elecsys BRAHMS PCT assay is a two-step sandwich immunoassay with streptavidin microparticles, biotinylated antibody and antibody labeled with ruthenium as well as an electrochemiluminescence detection system. Procalcitonin (PCT) in the sample reacts with these labeled antibodies to form a sandwich complex. This complex binds to streptavidin coated magnetic microparticles, which are magnetically captured onto an electrode. Application of voltage to the electrode induces chemiluminescence which is measured by a photomultiplier tube. Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent barcode. Total duration of assay: 18 minutes. K192815 - Page 4 of 20 • 1st incubation: Antigen in the sample (30 μL), a biotinylated monoclonal PCT-specific antibody, and a monoclonal PCT-specific antibody labeled with a ruthenium complex*) react to form a sandwich complex. • 2nd incubation: After addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin. • The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell M. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier. • Results are determined via a calibration curve which is instrument-specifically generated by 2-
point calibration and a master curve provided via the reagent barcode. (*):Tris(2,2'-bipyridyl)ruthenium(II)-complex (Ru(bpy)₃²⁺) C Reagents The reagent working solutions include: Rackpack (kit placed on analyzer) • M: Streptavidin-coated microparticles, • R1: Anti-PCT-Ab~biotin • R2: Anti-PCT-Ab~Ru(bpy)₃²⁺ The following change is proposed to block the interference of biotin with the Elecsys BRAHMS PCT assay: Roche is taking a one-step approach by adding an antibody to bind free biotin in the sample. For the neutralization of free biotin in serum and plasma, Roche developed an antibody which binds to free biotin. The antibodies are specific for free biotin and do not bind to, or interact with, the biotin-linker conjugates. V Substantial Equivalence Information: A Predicate Device Name(s): Elecsys BRAHMS PCT B Predicate 510(k) Number(s): K173927 C Comparison with Predicate(s): Device & Predicate Device(s): K192815 K173927 Device Trade Name Elecsys BRAHMS PCT Same K192815 - Page 5 of 20 Device & Predicate Device(s): K192815 K173927 General Device Characteristic Similarities Intended Use/ Indications for Use Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 –EDTA, K3-EDTA and Li-Heparin). The electrochemiluminescence immunoassay “ECLIA” is intended for use on Elecsys and cobas e immunoassay analyzers. Used in conjunction with other laboratory findings and clinical assessments, Elecsys BRAHMS PCT is intended for use as follows: • to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock, • to determine the change in PCT level over time as an aid in assessing
Applicant: |
idK192815_s0_e2000 | K192815.txt | proprietary and established names | Elecsys BRAHMS PCT | 20 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY I Background Information: The Elecsys BRAHMS PCT assay has been reformulated to address a 2017 FDA Safety Communication1 alerting the public, health care providers, lab personnel, and lab test developers that biotin can significantly interfere with certain lab tests and cause incorrect test results which may go undetected. A 510(k) Number K192815 B Applicant Roche Diagnostics C Proprietary and Established Names Elecsys BRAHMS PCT D Regulatory Information Product Code(s) Classification Regulation Section Panel PRI Class II 21 CFR 866.3215 - Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis MI - Microbiology II Submission/Device Overview: A Purpose for Submission: The purpose of this Traditional 510(k) Premarket Notification is to obtain FDA clearance for new reagents which have been added to the Elecsys BRAHMS PCT Test System. Additional reagents intended to minimize potentially interfering effects of biotin in a patient specimen have been added to the previously cleared product. B Measurand: 1 https://www.fda.gov/medical-devices/safety-communications/fda-warns-biotin-may-interfere-lab-tests-fda-safety-
communication K192815 - Page 2 of 20 Procalcitonin (PCT) C Type of Test: Quantitative, Electrochemiluminescence Immunoassay III Intended Use/Indications for Use: A Intended Use(s): See Indications for Use below. B Indication(s) for Use: Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 –EDTA, K3-EDTA and Li-Heparin). The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers. Used in conjunction with other laboratory findings and clinical assessments, Elecsys BRAHMS PCT is intended for use as follows: • to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock, • to determine the change in PCT level over time as an aid in assessing the cumulative 28-day risk of all-cause mortality for patients diagnosed with severe sepsis or septic shock in the ICU or when obtained in the emergency department or other medical wards prior to ICU admission, • to aid in decision making on antibiotic therapy, for inpatients or patients in the emergency department with suspected or confirmed lower respiratory tract infections (LRTI) – defined as community-acquired pneumonia (CAP), acute bronchitis, and acute exacerbation of chronic obstructive pulmonary disease (AECOPD), • to aid in decision making on antibiotic discontinuation for patients with suspected or confirmed sepsis. C Special Conditions for Use Statement(s): Rx - For Prescription Use Only Warnings and Precautions The Elecsys BRAHMS PCT is not indicated to be used as a stand-alone diagnostic assay and should be used in conjunction with clinical signs and symptoms of infection and other diagnostic evidence. In cases where the laboratory results do not agree with the clinical picture or history, additional tests should be K192815 - Page 3 of 20 performed. Changes in PCT should always be interpreted in the context of the clinical status of the patient and other laboratory results. Decisions regarding antibiotic therapy should NOT be based solely on procalcitonin concentrations. There is no uniformly recognized interpretation of the change in PCT concentration levels for the prediction of mortality, and overall mortality is strongly dependent on many factors, including pre-
existing patient risk factors and clinical course. The need to continue ICU care at Day 4 and other covariates (e.g., age, SOFA score) are also significant predictors of 28 day cumulative mortality risk. Validation of the Elecsys BRAHMS PCT test as an aid in predicting mortality was performed in a study population with an overall 28 day mortality of 22 %. Certain patient characteristics, such as severity of renal failure or insufficiency, may influence procalcitonin values and should be considered as potentially confounding clinical factors when interpreting PCT values. Increased PCT levels may be observed in severe illness such as polytrauma, burns, major surgery, prolonged or cardiogenic shock. PCT levels may not be elevated in patients infected by certain atypical pathogens, such as Chlamydia pneumoniae and Mycoplasma pneumoniae. The safety and performance of PCT-guided therapy for individuals younger than age 17 years, pregnant women, immunocompromised individuals or those on immunomodulatory agents, was not formally analyzed in the supportive clinical trials. D Special Instrument Requirements: The submission demonstrates performance on the cobas e 601 immunoassay analyzer. IV Device/System Characteristics: A Device Description: The Elecsys BRAHMS PCT assay is intended for use with the cobas e immunoassay analyzers, PCT Cal1 and Cal2 reagents, and the PreciControl PCT1 and PCT2 as part of the Elecsys BRAHMS PCT Kit. An optional Procalcitonin CalCheck product is also available. B Principle of Operation: The Elecsys BRAHMS PCT assay is a two-step sandwich immunoassay with streptavidin microparticles, biotinylated antibody and antibody labeled with ruthenium as well as an electrochemiluminescence detection system. Procalcitonin (PCT) in the sample reacts with these labeled antibodies to form a sandwich complex. This complex binds to streptavidin coated magnetic microparticles, which are magnetically captured onto an electrode. Application of voltage to the electrode induces chemiluminescence which is measured by a photomultiplier tube. Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent barcode. Total duration of assay: 18 minutes. K192815 - Page 4 of 20 • 1st incubation: Antigen in the sample (30 μL), a biotinylated monoclonal PCT-specific antibody, and a monoclonal PCT-specific antibody labeled with a ruthenium complex*) react to form a sandwich complex. • 2nd incubation: After addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin. • The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell M. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier. • Results are determined via a calibration curve which is instrument-specifically generated by 2-
point calibration and a master curve provided via the reagent barcode. (*):Tris(2,2'-bipyridyl)ruthenium(II)-complex (Ru(bpy)₃²⁺) C Reagents The reagent working solutions include: Rackpack (kit placed on analyzer) • M: Streptavidin-coated microparticles, • R1: Anti-PCT-Ab~biotin • R2: Anti-PCT-Ab~Ru(bpy)₃²⁺ The following change is proposed to block the interference of biotin with the Elecsys BRAHMS PCT assay: Roche is taking a one-step approach by adding an antibody to bind free biotin in the sample. For the neutralization of free biotin in serum and plasma, Roche developed an antibody which binds to free biotin. The antibodies are specific for free biotin and do not bind to, or interact with, the biotin-linker conjugates. V Substantial Equivalence Information: A Predicate Device Name(s): Elecsys BRAHMS PCT B Predicate 510(k) Number(s): K173927 C Comparison with Predicate(s): Device & Predicate Device(s): K192815 K173927 Device Trade Name Elecsys BRAHMS PCT Same K192815 - Page 5 of 20 Device & Predicate Device(s): K192815 K173927 General Device Characteristic Similarities Intended Use/ Indications for Use Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 –EDTA, K3-EDTA and Li-Heparin). The electrochemiluminescence immunoassay “ECLIA” is intended for use on Elecsys and cobas e immunoassay analyzers. Used in conjunction with other laboratory findings and clinical assessments, Elecsys BRAHMS PCT is intended for use as follows: • to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock, • to determine the change in PCT level over time as an aid in assessing
Proprietary and established names: |
idK192815_s0_e2000 | K192815.txt | regulation section | 21 CFR 866.3215 - Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis | Page 1 of 20 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY I Background Information: The Elecsys BRAHMS PCT assay has been reformulated to address a 2017 FDA Safety Communication1 alerting the public, health care providers, lab personnel, and lab test developers that biotin can significantly interfere with certain lab tests and cause incorrect test results which may go undetected. A 510(k) Number K192815 B Applicant Roche Diagnostics C Proprietary and Established Names Elecsys BRAHMS PCT D Regulatory Information Product Code(s) Classification Regulation Section Panel PRI Class II 21 CFR 866.3215 - Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis MI - Microbiology II Submission/Device Overview: A Purpose for Submission: The purpose of this Traditional 510(k) Premarket Notification is to obtain FDA clearance for new reagents which have been added to the Elecsys BRAHMS PCT Test System. Additional reagents intended to minimize potentially interfering effects of biotin in a patient specimen have been added to the previously cleared product. B Measurand: 1 https://www.fda.gov/medical-devices/safety-communications/fda-warns-biotin-may-interfere-lab-tests-fda-safety-
communication K192815 - Page 2 of 20 Procalcitonin (PCT) C Type of Test: Quantitative, Electrochemiluminescence Immunoassay III Intended Use/Indications for Use: A Intended Use(s): See Indications for Use below. B Indication(s) for Use: Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 –EDTA, K3-EDTA and Li-Heparin). The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers. Used in conjunction with other laboratory findings and clinical assessments, Elecsys BRAHMS PCT is intended for use as follows: • to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock, • to determine the change in PCT level over time as an aid in assessing the cumulative 28-day risk of all-cause mortality for patients diagnosed with severe sepsis or septic shock in the ICU or when obtained in the emergency department or other medical wards prior to ICU admission, • to aid in decision making on antibiotic therapy, for inpatients or patients in the emergency department with suspected or confirmed lower respiratory tract infections (LRTI) – defined as community-acquired pneumonia (CAP), acute bronchitis, and acute exacerbation of chronic obstructive pulmonary disease (AECOPD), • to aid in decision making on antibiotic discontinuation for patients with suspected or confirmed sepsis. C Special Conditions for Use Statement(s): Rx - For Prescription Use Only Warnings and Precautions The Elecsys BRAHMS PCT is not indicated to be used as a stand-alone diagnostic assay and should be used in conjunction with clinical signs and symptoms of infection and other diagnostic evidence. In cases where the laboratory results do not agree with the clinical picture or history, additional tests should be K192815 - Page 3 of 20 performed. Changes in PCT should always be interpreted in the context of the clinical status of the patient and other laboratory results. Decisions regarding antibiotic therapy should NOT be based solely on procalcitonin concentrations. There is no uniformly recognized interpretation of the change in PCT concentration levels for the prediction of mortality, and overall mortality is strongly dependent on many factors, including pre-
existing patient risk factors and clinical course. The need to continue ICU care at Day 4 and other covariates (e.g., age, SOFA score) are also significant predictors of 28 day cumulative mortality risk. Validation of the Elecsys BRAHMS PCT test as an aid in predicting mortality was performed in a study population with an overall 28 day mortality of 22 %. Certain patient characteristics, such as severity of renal failure or insufficiency, may influence procalcitonin values and should be considered as potentially confounding clinical factors when interpreting PCT values. Increased PCT levels may be observed in severe illness such as polytrauma, burns, major surgery, prolonged or cardiogenic shock. PCT levels may not be elevated in patients infected by certain atypical pathogens, such as Chlamydia pneumoniae and Mycoplasma pneumoniae. The safety and performance of PCT-guided therapy for individuals younger than age 17 years, pregnant women, immunocompromised individuals or those on immunomodulatory agents, was not formally analyzed in the supportive clinical trials. D Special Instrument Requirements: The submission demonstrates performance on the cobas e 601 immunoassay analyzer. IV Device/System Characteristics: A Device Description: The Elecsys BRAHMS PCT assay is intended for use with the cobas e immunoassay analyzers, PCT Cal1 and Cal2 reagents, and the PreciControl PCT1 and PCT2 as part of the Elecsys BRAHMS PCT Kit. An optional Procalcitonin CalCheck product is also available. B Principle of Operation: The Elecsys BRAHMS PCT assay is a two-step sandwich immunoassay with streptavidin microparticles, biotinylated antibody and antibody labeled with ruthenium as well as an electrochemiluminescence detection system. Procalcitonin (PCT) in the sample reacts with these labeled antibodies to form a sandwich complex. This complex binds to streptavidin coated magnetic microparticles, which are magnetically captured onto an electrode. Application of voltage to the electrode induces chemiluminescence which is measured by a photomultiplier tube. Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent barcode. Total duration of assay: 18 minutes. K192815 - Page 4 of 20 • 1st incubation: Antigen in the sample (30 μL), a biotinylated monoclonal PCT-specific antibody, and a monoclonal PCT-specific antibody labeled with a ruthenium complex*) react to form a sandwich complex. • 2nd incubation: After addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin. • The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell M. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier. • Results are determined via a calibration curve which is instrument-specifically generated by 2-
point calibration and a master curve provided via the reagent barcode. (*):Tris(2,2'-bipyridyl)ruthenium(II)-complex (Ru(bpy)₃²⁺) C Reagents The reagent working solutions include: Rackpack (kit placed on analyzer) • M: Streptavidin-coated microparticles, • R1: Anti-PCT-Ab~biotin • R2: Anti-PCT-Ab~Ru(bpy)₃²⁺ The following change is proposed to block the interference of biotin with the Elecsys BRAHMS PCT assay: Roche is taking a one-step approach by adding an antibody to bind free biotin in the sample. For the neutralization of free biotin in serum and plasma, Roche developed an antibody which binds to free biotin. The antibodies are specific for free biotin and do not bind to, or interact with, the biotin-linker conjugates. V Substantial Equivalence Information: A Predicate Device Name(s): Elecsys BRAHMS PCT B Predicate 510(k) Number(s): K173927 C Comparison with Predicate(s): Device & Predicate Device(s): K192815 K173927 Device Trade Name Elecsys BRAHMS PCT Same K192815 - Page 5 of 20 Device & Predicate Device(s): K192815 K173927 General Device Characteristic Similarities Intended Use/ Indications for Use Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 –EDTA, K3-EDTA and Li-Heparin). The electrochemiluminescence immunoassay “ECLIA” is intended for use on Elecsys and cobas e immunoassay analyzers. Used in conjunction with other laboratory findings and clinical assessments, Elecsys BRAHMS PCT is intended for use as follows: • to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock, • to determine the change in PCT level over time as an aid in assessing
Regulation section: |
idK192815_s8000_e10000 | K192815.txt | proposed labeling | The labeling supports the finding of substantial equivalence for this device. | ] [0.963; 0.975] Intercept -0.003 0.004 95% CI [-0.004; -0.001] [0.002; 0.005] Pearson Correlation Coefficient (R) 1.000 1.000 Sample Range [0.02; 85.69] [0.02; 85.69] K192815 - Page 19 of 20 Figure 1: Weighted Deming Regression plots of Elecsys BRAHMS PCT versus Predicate Figure 2: Passing Bablok Regression plots of Elecsys BRAHMS PCT versus Predicate K192815 - Page 20 of 20 2. Matrix Comparison: The effect on quantitation of analyte in the presence of anticoagulants with the Elecsys BRAHMS PCT immunoassay was determined by comparing values obtained from samples (native human serum samples, single donors as well as pools) drawn into serum and Li-Heparin, K2-EDTA, K3-EDTA plasma tubes. A minimum of 40 serum/plasma pairs per sample material were tested in singleton with one reagent lot on one cobas e 601 analyzer. Data were evaluated using a regression analysis according to Passing/Bablok. The results are acceptable and supports the following package-insert claim: • SST is an acceptable sample type for use with the Elecsys PCT assay • Li-Heparin plasma is an acceptable sample type for use with the Elecsys BRAHMS PCT assay • K2-EDTA plasma is an acceptable sample type for use with the Elecsys BRAHMS PCT assay. • K3-EDTA plasma is an acceptable sample type for use with the Elecsys BRAHMS PCT assay. C Clinical Studies: Not Applicable VIII Proposed Labeling: The labeling supports the finding of substantial equivalence for this device. IX Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
Proposed labeling: |
idK192815_s8000_e10000 | K192815.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | .994] [0.963; 0.975] Intercept -0.003 0.004 95% CI [-0.004; -0.001] [0.002; 0.005] Pearson Correlation Coefficient (R) 1.000 1.000 Sample Range [0.02; 85.69] [0.02; 85.69] K192815 - Page 19 of 20 Figure 1: Weighted Deming Regression plots of Elecsys BRAHMS PCT versus Predicate Figure 2: Passing Bablok Regression plots of Elecsys BRAHMS PCT versus Predicate K192815 - Page 20 of 20 2. Matrix Comparison: The effect on quantitation of analyte in the presence of anticoagulants with the Elecsys BRAHMS PCT immunoassay was determined by comparing values obtained from samples (native human serum samples, single donors as well as pools) drawn into serum and Li-Heparin, K2-EDTA, K3-EDTA plasma tubes. A minimum of 40 serum/plasma pairs per sample material were tested in singleton with one reagent lot on one cobas e 601 analyzer. Data were evaluated using a regression analysis according to Passing/Bablok. The results are acceptable and supports the following package-insert claim: • SST is an acceptable sample type for use with the Elecsys PCT assay • Li-Heparin plasma is an acceptable sample type for use with the Elecsys BRAHMS PCT assay • K2-EDTA plasma is an acceptable sample type for use with the Elecsys BRAHMS PCT assay. • K3-EDTA plasma is an acceptable sample type for use with the Elecsys BRAHMS PCT assay. C Clinical Studies: Not Applicable VIII Proposed Labeling: The labeling supports the finding of substantial equivalence for this device. IX Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
Conclusion: |
idK183415_s0_e2000 | K183415.txt | purpose for submission | To obtain a substantial equivalence determination for imipenem at concentrations of 0.25 – 16 µg/mL for susceptibility testing of gram-negative aerobic organisms on the VITEK 2 and VITEK 2 Compact Antimicrobial Susceptibility Test (AST) Systems. | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K183415 B. Purpose for Submission: To obtain a substantial equivalence determination for imipenem at concentrations of 0.25 – 16 µg/mL for susceptibility testing of gram-negative aerobic organisms on the VITEK 2 and VITEK 2 Compact Antimicrobial Susceptibility Test (AST) Systems. C. Measurand: Imipenem 0.25 – 16 µg/mL D. Type of Test: Automated quantitative antimicrobial susceptibility (AST) E. Applicant: bioMérieux, Inc. F. Proprietary and Established Names: VITEK 2 AST-Gram Negative Imipenem (≤0.25 - ≥16 µg/mL) G. Regulatory Information: 1. Regulation section: 21 CFR 866.1645 Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System 2. Classification: Class II 3. Product code: LON – Fully automated short-term incubation cycle antimicrobial susceptibility system 2
LTW – Susceptibility Test Cards, Automated LTT – Panels, Test, Susceptibility, Automated 4. Panel: 83 Microbiology H. Intended Use: 1. Intended use(s): The VITEK 2 Gram-negative Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic Gram-negative bacilli to antimicrobial agents when used as instructed. 2. Indication(s) for use: VITEK 2 AST-Gram Negative Imipenem is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK 2 AST Gram Negative Imipenem is a quantitative test. Imipenem has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. Active in vitro and in clinical infections: Acinetobacter spp. Citrobacter spp. Enterobacter cloacae/E. cloacae complex Escherichia coli Klebsiella spp. Pseudomonas aeruginosa The VITEK 2 Gram-negative Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic Gram-negative bacilli to antimicrobial agents when used as instructed. 3. Special conditions for use statement(s): Prescription use only 3
Limitations Perform an alternative method of testing prior to reporting of results for the following antibiotic/organism combinations: Imipenem (ipm05n): Klebsiella (Enterobacter) aerogenes, Proteus species, Providencia species, Morganella species and Serratia species. 4. Special instrument requirements: VITEK 2 and VITEK 2 Compact Systems I. Device Description: The VITEK® 2 AST card is a miniaturized, abbreviated and automated version of the doubling dilution technique for determining the minimum inhibitory concentration (MIC). Each VITEK® 2 AST card contains 64 wells. A control well(s) which contain only nutrient medium is resident on all cards. The remaining wells contain premeasured portions of antimicrobials combined with the nutrient media. The isolate to be tested is diluted to a standardized concentration with 0.45% to 0.50% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK 2 System will automatically dilute the bacterial suspension to prepare an inoculum for susceptibility cards. Then the VITEK® 2 will fill, seal and place the card into the incubator/reader. The VITEK 2 Compact has a manual filling, sealing and loading operation. The VITEK 2 Systems monitor the growth of each well in the card over a defined period of time (up to 24 hours for Streptococcus species). The analysis program determines when a well demonstrates growth based on attenuation of light measured by an optical scanner. This data is used to determine the minimum inhibitory concentration or MIC values for the anti-microbial agent. At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antimicrobial contained on the card. VITEK 2 AST-GN Imipenem has the following concentrations in the card: 0.5, 2, 8, and 16 µg/mL (equivalent standard method concentration by efficacy in µg/mL). The MIC result range for VITEK 2 AST-GN Imipenem on the VITEK 2 card is ≤ 0.25 - ≥ 16 µg/mL for Enterobacteriaceae and ≤ 0.5 - ≥ 16 µg/mL for Acinetobacter spp. and P. aeruginosa. J. Substantial Equivalence Information: 1. Predicate device name(s): VITEK 2 AST-GN Amikacin 2. Predicate 510(k) number(s): K172731 4
3. Comparison with predicate: Table 1. Comparison with the Predicate Device Similarities Item Device K183425 VITEK 2 AST-
GN Imipenem Predicate K172731 VITEK 2 AST-
GN Amikacin Intended Use VITEK 2 AST-Gram Negative Imipenem is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK 2 AST Gram Negative Imipenem is a quantitative test. Imipenem has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. Active in vitro and in clinical infections: Acinetobacter spp. Citrobacter spp. Enterobacter cloacae/E. cloacae complex Escherichia coli Klebsiella spp. Pseudomonas aeruginosa VITEK 2 AST Gram Negative Amikacin is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK 2 AST Gram Negative Amikacin is a quantitative test. Amikacin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. Active in vitro and in clinical infections: Pseudomonas spp. Escherichia coli Proteus mirabilis Klebsiella spp. Enterobacter spp. Serratia spp. Acinetobacter species (excluding A. baumannii Complex) In vitro data available but clinical significance is unknown: Citrobacter freundii Test Methodology Automated quantitative Same 5
Similarities
Item
Device
K183425 VITEK 2 AST-
GN Imipenem
Predicate K172731 VITEK 2 AST-
GN Amikacin antimicrobial susceptibility test for use with the VITEK 2 and VITEK 2 Compact Systems to determine the in vitro susceptibility of Gram negative bacilli Inoculum
Saline suspension of organism
Same Test Card
VITEK 2 Gram Negative Susceptibility Test Card
Same Instrument VITEK 2 and VITEK 2 Compact Same Analysis Algorithm
Growth Pattern Analysis
Same Differences
Item Device K183425 VITEK 2 AST-
GN Imipenem Predicate
K172731 VITEK 2 AST-
GN Amikacin
Antimicrobial Agent
Imipenem
Amikacin
Antimicrobial Concentrations
0.5, 2, 8, 16
2, 4, 16, 48
K. Standard/Guidance Document Referenced (if applicable):
CLSI Document M07-A10, Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard – Tenth Edition, Vol. 35, No. 2; January, 2015. Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems Guidance for Industry and FDA, August 2009. L. Test Principle: The VITEK® 2 and VITEK® 2 Compact Systems utilize automated growth-based detection using attenuation of light measured by an optical scanner. The optics used in the systems use visible light to directly measure organism growth. Transmittance optics are based on an initial light reading of a well before significant growth has begun. Periodic light transmittance samplings of the same well measure organism growth by how much light is prevented from going through the well. The VITEK 2 System monitors the growth of each well in the card over a defined period of time. An interpretive call is made between 4 and 16 6
hours for a “rapid” read but may be extended to 18 hours in some instances. At the completion of the incubation cycle, a report is generated that contains the MIC value
Purpose for submission: |
idK183415_s0_e2000 | K183415.txt | measurand | Imipenem 0.25 – 16 µg/mL | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K183415 B. Purpose for Submission: To obtain a substantial equivalence determination for imipenem at concentrations of 0.25 – 16 µg/mL for susceptibility testing of gram-negative aerobic organisms on the VITEK 2 and VITEK 2 Compact Antimicrobial Susceptibility Test (AST) Systems. C. Measurand: Imipenem 0.25 – 16 µg/mL D. Type of Test: Automated quantitative antimicrobial susceptibility (AST) E. Applicant: bioMérieux, Inc. F. Proprietary and Established Names: VITEK 2 AST-Gram Negative Imipenem (≤0.25 - ≥16 µg/mL) G. Regulatory Information: 1. Regulation section: 21 CFR 866.1645 Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System 2. Classification: Class II 3. Product code: LON – Fully automated short-term incubation cycle antimicrobial susceptibility system 2
LTW – Susceptibility Test Cards, Automated LTT – Panels, Test, Susceptibility, Automated 4. Panel: 83 Microbiology H. Intended Use: 1. Intended use(s): The VITEK 2 Gram-negative Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic Gram-negative bacilli to antimicrobial agents when used as instructed. 2. Indication(s) for use: VITEK 2 AST-Gram Negative Imipenem is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK 2 AST Gram Negative Imipenem is a quantitative test. Imipenem has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. Active in vitro and in clinical infections: Acinetobacter spp. Citrobacter spp. Enterobacter cloacae/E. cloacae complex Escherichia coli Klebsiella spp. Pseudomonas aeruginosa The VITEK 2 Gram-negative Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic Gram-negative bacilli to antimicrobial agents when used as instructed. 3. Special conditions for use statement(s): Prescription use only 3
Limitations Perform an alternative method of testing prior to reporting of results for the following antibiotic/organism combinations: Imipenem (ipm05n): Klebsiella (Enterobacter) aerogenes, Proteus species, Providencia species, Morganella species and Serratia species. 4. Special instrument requirements: VITEK 2 and VITEK 2 Compact Systems I. Device Description: The VITEK® 2 AST card is a miniaturized, abbreviated and automated version of the doubling dilution technique for determining the minimum inhibitory concentration (MIC). Each VITEK® 2 AST card contains 64 wells. A control well(s) which contain only nutrient medium is resident on all cards. The remaining wells contain premeasured portions of antimicrobials combined with the nutrient media. The isolate to be tested is diluted to a standardized concentration with 0.45% to 0.50% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK 2 System will automatically dilute the bacterial suspension to prepare an inoculum for susceptibility cards. Then the VITEK® 2 will fill, seal and place the card into the incubator/reader. The VITEK 2 Compact has a manual filling, sealing and loading operation. The VITEK 2 Systems monitor the growth of each well in the card over a defined period of time (up to 24 hours for Streptococcus species). The analysis program determines when a well demonstrates growth based on attenuation of light measured by an optical scanner. This data is used to determine the minimum inhibitory concentration or MIC values for the anti-microbial agent. At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antimicrobial contained on the card. VITEK 2 AST-GN Imipenem has the following concentrations in the card: 0.5, 2, 8, and 16 µg/mL (equivalent standard method concentration by efficacy in µg/mL). The MIC result range for VITEK 2 AST-GN Imipenem on the VITEK 2 card is ≤ 0.25 - ≥ 16 µg/mL for Enterobacteriaceae and ≤ 0.5 - ≥ 16 µg/mL for Acinetobacter spp. and P. aeruginosa. J. Substantial Equivalence Information: 1. Predicate device name(s): VITEK 2 AST-GN Amikacin 2. Predicate 510(k) number(s): K172731 4
3. Comparison with predicate: Table 1. Comparison with the Predicate Device Similarities Item Device K183425 VITEK 2 AST-
GN Imipenem Predicate K172731 VITEK 2 AST-
GN Amikacin Intended Use VITEK 2 AST-Gram Negative Imipenem is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK 2 AST Gram Negative Imipenem is a quantitative test. Imipenem has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. Active in vitro and in clinical infections: Acinetobacter spp. Citrobacter spp. Enterobacter cloacae/E. cloacae complex Escherichia coli Klebsiella spp. Pseudomonas aeruginosa VITEK 2 AST Gram Negative Amikacin is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK 2 AST Gram Negative Amikacin is a quantitative test. Amikacin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. Active in vitro and in clinical infections: Pseudomonas spp. Escherichia coli Proteus mirabilis Klebsiella spp. Enterobacter spp. Serratia spp. Acinetobacter species (excluding A. baumannii Complex) In vitro data available but clinical significance is unknown: Citrobacter freundii Test Methodology Automated quantitative Same 5
Similarities
Item
Device
K183425 VITEK 2 AST-
GN Imipenem
Predicate K172731 VITEK 2 AST-
GN Amikacin antimicrobial susceptibility test for use with the VITEK 2 and VITEK 2 Compact Systems to determine the in vitro susceptibility of Gram negative bacilli Inoculum
Saline suspension of organism
Same Test Card
VITEK 2 Gram Negative Susceptibility Test Card
Same Instrument VITEK 2 and VITEK 2 Compact Same Analysis Algorithm
Growth Pattern Analysis
Same Differences
Item Device K183425 VITEK 2 AST-
GN Imipenem Predicate
K172731 VITEK 2 AST-
GN Amikacin
Antimicrobial Agent
Imipenem
Amikacin
Antimicrobial Concentrations
0.5, 2, 8, 16
2, 4, 16, 48
K. Standard/Guidance Document Referenced (if applicable):
CLSI Document M07-A10, Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard – Tenth Edition, Vol. 35, No. 2; January, 2015. Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems Guidance for Industry and FDA, August 2009. L. Test Principle: The VITEK® 2 and VITEK® 2 Compact Systems utilize automated growth-based detection using attenuation of light measured by an optical scanner. The optics used in the systems use visible light to directly measure organism growth. Transmittance optics are based on an initial light reading of a well before significant growth has begun. Periodic light transmittance samplings of the same well measure organism growth by how much light is prevented from going through the well. The VITEK 2 System monitors the growth of each well in the card over a defined period of time. An interpretive call is made between 4 and 16 6
hours for a “rapid” read but may be extended to 18 hours in some instances. At the completion of the incubation cycle, a report is generated that contains the MIC value
Measurand: |
idK183415_s0_e2000 | K183415.txt | type of test | Automated quantitative antimicrobial susceptibility (AST) | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K183415 B. Purpose for Submission: To obtain a substantial equivalence determination for imipenem at concentrations of 0.25 – 16 µg/mL for susceptibility testing of gram-negative aerobic organisms on the VITEK 2 and VITEK 2 Compact Antimicrobial Susceptibility Test (AST) Systems. C. Measurand: Imipenem 0.25 – 16 µg/mL D. Type of Test: Automated quantitative antimicrobial susceptibility (AST) E. Applicant: bioMérieux, Inc. F. Proprietary and Established Names: VITEK 2 AST-Gram Negative Imipenem (≤0.25 - ≥16 µg/mL) G. Regulatory Information: 1. Regulation section: 21 CFR 866.1645 Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System 2. Classification: Class II 3. Product code: LON – Fully automated short-term incubation cycle antimicrobial susceptibility system 2
LTW – Susceptibility Test Cards, Automated LTT – Panels, Test, Susceptibility, Automated 4. Panel: 83 Microbiology H. Intended Use: 1. Intended use(s): The VITEK 2 Gram-negative Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic Gram-negative bacilli to antimicrobial agents when used as instructed. 2. Indication(s) for use: VITEK 2 AST-Gram Negative Imipenem is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK 2 AST Gram Negative Imipenem is a quantitative test. Imipenem has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. Active in vitro and in clinical infections: Acinetobacter spp. Citrobacter spp. Enterobacter cloacae/E. cloacae complex Escherichia coli Klebsiella spp. Pseudomonas aeruginosa The VITEK 2 Gram-negative Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic Gram-negative bacilli to antimicrobial agents when used as instructed. 3. Special conditions for use statement(s): Prescription use only 3
Limitations Perform an alternative method of testing prior to reporting of results for the following antibiotic/organism combinations: Imipenem (ipm05n): Klebsiella (Enterobacter) aerogenes, Proteus species, Providencia species, Morganella species and Serratia species. 4. Special instrument requirements: VITEK 2 and VITEK 2 Compact Systems I. Device Description: The VITEK® 2 AST card is a miniaturized, abbreviated and automated version of the doubling dilution technique for determining the minimum inhibitory concentration (MIC). Each VITEK® 2 AST card contains 64 wells. A control well(s) which contain only nutrient medium is resident on all cards. The remaining wells contain premeasured portions of antimicrobials combined with the nutrient media. The isolate to be tested is diluted to a standardized concentration with 0.45% to 0.50% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK 2 System will automatically dilute the bacterial suspension to prepare an inoculum for susceptibility cards. Then the VITEK® 2 will fill, seal and place the card into the incubator/reader. The VITEK 2 Compact has a manual filling, sealing and loading operation. The VITEK 2 Systems monitor the growth of each well in the card over a defined period of time (up to 24 hours for Streptococcus species). The analysis program determines when a well demonstrates growth based on attenuation of light measured by an optical scanner. This data is used to determine the minimum inhibitory concentration or MIC values for the anti-microbial agent. At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antimicrobial contained on the card. VITEK 2 AST-GN Imipenem has the following concentrations in the card: 0.5, 2, 8, and 16 µg/mL (equivalent standard method concentration by efficacy in µg/mL). The MIC result range for VITEK 2 AST-GN Imipenem on the VITEK 2 card is ≤ 0.25 - ≥ 16 µg/mL for Enterobacteriaceae and ≤ 0.5 - ≥ 16 µg/mL for Acinetobacter spp. and P. aeruginosa. J. Substantial Equivalence Information: 1. Predicate device name(s): VITEK 2 AST-GN Amikacin 2. Predicate 510(k) number(s): K172731 4
3. Comparison with predicate: Table 1. Comparison with the Predicate Device Similarities Item Device K183425 VITEK 2 AST-
GN Imipenem Predicate K172731 VITEK 2 AST-
GN Amikacin Intended Use VITEK 2 AST-Gram Negative Imipenem is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK 2 AST Gram Negative Imipenem is a quantitative test. Imipenem has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. Active in vitro and in clinical infections: Acinetobacter spp. Citrobacter spp. Enterobacter cloacae/E. cloacae complex Escherichia coli Klebsiella spp. Pseudomonas aeruginosa VITEK 2 AST Gram Negative Amikacin is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK 2 AST Gram Negative Amikacin is a quantitative test. Amikacin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. Active in vitro and in clinical infections: Pseudomonas spp. Escherichia coli Proteus mirabilis Klebsiella spp. Enterobacter spp. Serratia spp. Acinetobacter species (excluding A. baumannii Complex) In vitro data available but clinical significance is unknown: Citrobacter freundii Test Methodology Automated quantitative Same 5
Similarities
Item
Device
K183425 VITEK 2 AST-
GN Imipenem
Predicate K172731 VITEK 2 AST-
GN Amikacin antimicrobial susceptibility test for use with the VITEK 2 and VITEK 2 Compact Systems to determine the in vitro susceptibility of Gram negative bacilli Inoculum
Saline suspension of organism
Same Test Card
VITEK 2 Gram Negative Susceptibility Test Card
Same Instrument VITEK 2 and VITEK 2 Compact Same Analysis Algorithm
Growth Pattern Analysis
Same Differences
Item Device K183425 VITEK 2 AST-
GN Imipenem Predicate
K172731 VITEK 2 AST-
GN Amikacin
Antimicrobial Agent
Imipenem
Amikacin
Antimicrobial Concentrations
0.5, 2, 8, 16
2, 4, 16, 48
K. Standard/Guidance Document Referenced (if applicable):
CLSI Document M07-A10, Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard – Tenth Edition, Vol. 35, No. 2; January, 2015. Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems Guidance for Industry and FDA, August 2009. L. Test Principle: The VITEK® 2 and VITEK® 2 Compact Systems utilize automated growth-based detection using attenuation of light measured by an optical scanner. The optics used in the systems use visible light to directly measure organism growth. Transmittance optics are based on an initial light reading of a well before significant growth has begun. Periodic light transmittance samplings of the same well measure organism growth by how much light is prevented from going through the well. The VITEK 2 System monitors the growth of each well in the card over a defined period of time. An interpretive call is made between 4 and 16 6
hours for a “rapid” read but may be extended to 18 hours in some instances. At the completion of the incubation cycle, a report is generated that contains the MIC value
Type of test: |
idK183415_s0_e2000 | K183415.txt | classification | Class II | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K183415 B. Purpose for Submission: To obtain a substantial equivalence determination for imipenem at concentrations of 0.25 – 16 µg/mL for susceptibility testing of gram-negative aerobic organisms on the VITEK 2 and VITEK 2 Compact Antimicrobial Susceptibility Test (AST) Systems. C. Measurand: Imipenem 0.25 – 16 µg/mL D. Type of Test: Automated quantitative antimicrobial susceptibility (AST) E. Applicant: bioMérieux, Inc. F. Proprietary and Established Names: VITEK 2 AST-Gram Negative Imipenem (≤0.25 - ≥16 µg/mL) G. Regulatory Information: 1. Regulation section: 21 CFR 866.1645 Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System 2. Classification: Class II 3. Product code: LON – Fully automated short-term incubation cycle antimicrobial susceptibility system 2
LTW – Susceptibility Test Cards, Automated LTT – Panels, Test, Susceptibility, Automated 4. Panel: 83 Microbiology H. Intended Use: 1. Intended use(s): The VITEK 2 Gram-negative Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic Gram-negative bacilli to antimicrobial agents when used as instructed. 2. Indication(s) for use: VITEK 2 AST-Gram Negative Imipenem is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK 2 AST Gram Negative Imipenem is a quantitative test. Imipenem has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. Active in vitro and in clinical infections: Acinetobacter spp. Citrobacter spp. Enterobacter cloacae/E. cloacae complex Escherichia coli Klebsiella spp. Pseudomonas aeruginosa The VITEK 2 Gram-negative Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic Gram-negative bacilli to antimicrobial agents when used as instructed. 3. Special conditions for use statement(s): Prescription use only 3
Limitations Perform an alternative method of testing prior to reporting of results for the following antibiotic/organism combinations: Imipenem (ipm05n): Klebsiella (Enterobacter) aerogenes, Proteus species, Providencia species, Morganella species and Serratia species. 4. Special instrument requirements: VITEK 2 and VITEK 2 Compact Systems I. Device Description: The VITEK® 2 AST card is a miniaturized, abbreviated and automated version of the doubling dilution technique for determining the minimum inhibitory concentration (MIC). Each VITEK® 2 AST card contains 64 wells. A control well(s) which contain only nutrient medium is resident on all cards. The remaining wells contain premeasured portions of antimicrobials combined with the nutrient media. The isolate to be tested is diluted to a standardized concentration with 0.45% to 0.50% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK 2 System will automatically dilute the bacterial suspension to prepare an inoculum for susceptibility cards. Then the VITEK® 2 will fill, seal and place the card into the incubator/reader. The VITEK 2 Compact has a manual filling, sealing and loading operation. The VITEK 2 Systems monitor the growth of each well in the card over a defined period of time (up to 24 hours for Streptococcus species). The analysis program determines when a well demonstrates growth based on attenuation of light measured by an optical scanner. This data is used to determine the minimum inhibitory concentration or MIC values for the anti-microbial agent. At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antimicrobial contained on the card. VITEK 2 AST-GN Imipenem has the following concentrations in the card: 0.5, 2, 8, and 16 µg/mL (equivalent standard method concentration by efficacy in µg/mL). The MIC result range for VITEK 2 AST-GN Imipenem on the VITEK 2 card is ≤ 0.25 - ≥ 16 µg/mL for Enterobacteriaceae and ≤ 0.5 - ≥ 16 µg/mL for Acinetobacter spp. and P. aeruginosa. J. Substantial Equivalence Information: 1. Predicate device name(s): VITEK 2 AST-GN Amikacin 2. Predicate 510(k) number(s): K172731 4
3. Comparison with predicate: Table 1. Comparison with the Predicate Device Similarities Item Device K183425 VITEK 2 AST-
GN Imipenem Predicate K172731 VITEK 2 AST-
GN Amikacin Intended Use VITEK 2 AST-Gram Negative Imipenem is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK 2 AST Gram Negative Imipenem is a quantitative test. Imipenem has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. Active in vitro and in clinical infections: Acinetobacter spp. Citrobacter spp. Enterobacter cloacae/E. cloacae complex Escherichia coli Klebsiella spp. Pseudomonas aeruginosa VITEK 2 AST Gram Negative Amikacin is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK 2 AST Gram Negative Amikacin is a quantitative test. Amikacin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. Active in vitro and in clinical infections: Pseudomonas spp. Escherichia coli Proteus mirabilis Klebsiella spp. Enterobacter spp. Serratia spp. Acinetobacter species (excluding A. baumannii Complex) In vitro data available but clinical significance is unknown: Citrobacter freundii Test Methodology Automated quantitative Same 5
Similarities
Item
Device
K183425 VITEK 2 AST-
GN Imipenem
Predicate K172731 VITEK 2 AST-
GN Amikacin antimicrobial susceptibility test for use with the VITEK 2 and VITEK 2 Compact Systems to determine the in vitro susceptibility of Gram negative bacilli Inoculum
Saline suspension of organism
Same Test Card
VITEK 2 Gram Negative Susceptibility Test Card
Same Instrument VITEK 2 and VITEK 2 Compact Same Analysis Algorithm
Growth Pattern Analysis
Same Differences
Item Device K183425 VITEK 2 AST-
GN Imipenem Predicate
K172731 VITEK 2 AST-
GN Amikacin
Antimicrobial Agent
Imipenem
Amikacin
Antimicrobial Concentrations
0.5, 2, 8, 16
2, 4, 16, 48
K. Standard/Guidance Document Referenced (if applicable):
CLSI Document M07-A10, Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard – Tenth Edition, Vol. 35, No. 2; January, 2015. Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems Guidance for Industry and FDA, August 2009. L. Test Principle: The VITEK® 2 and VITEK® 2 Compact Systems utilize automated growth-based detection using attenuation of light measured by an optical scanner. The optics used in the systems use visible light to directly measure organism growth. Transmittance optics are based on an initial light reading of a well before significant growth has begun. Periodic light transmittance samplings of the same well measure organism growth by how much light is prevented from going through the well. The VITEK 2 System monitors the growth of each well in the card over a defined period of time. An interpretive call is made between 4 and 16 6
hours for a “rapid” read but may be extended to 18 hours in some instances. At the completion of the incubation cycle, a report is generated that contains the MIC value
Classification: |
idK183415_s0_e2000 | K183415.txt | panel | 83 Microbiology | (k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K183415 B. Purpose for Submission: To obtain a substantial equivalence determination for imipenem at concentrations of 0.25 – 16 µg/mL for susceptibility testing of gram-negative aerobic organisms on the VITEK 2 and VITEK 2 Compact Antimicrobial Susceptibility Test (AST) Systems. C. Measurand: Imipenem 0.25 – 16 µg/mL D. Type of Test: Automated quantitative antimicrobial susceptibility (AST) E. Applicant: bioMérieux, Inc. F. Proprietary and Established Names: VITEK 2 AST-Gram Negative Imipenem (≤0.25 - ≥16 µg/mL) G. Regulatory Information: 1. Regulation section: 21 CFR 866.1645 Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System 2. Classification: Class II 3. Product code: LON – Fully automated short-term incubation cycle antimicrobial susceptibility system 2
LTW – Susceptibility Test Cards, Automated LTT – Panels, Test, Susceptibility, Automated 4. Panel: 83 Microbiology H. Intended Use: 1. Intended use(s): The VITEK 2 Gram-negative Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic Gram-negative bacilli to antimicrobial agents when used as instructed. 2. Indication(s) for use: VITEK 2 AST-Gram Negative Imipenem is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK 2 AST Gram Negative Imipenem is a quantitative test. Imipenem has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. Active in vitro and in clinical infections: Acinetobacter spp. Citrobacter spp. Enterobacter cloacae/E. cloacae complex Escherichia coli Klebsiella spp. Pseudomonas aeruginosa The VITEK 2 Gram-negative Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic Gram-negative bacilli to antimicrobial agents when used as instructed. 3. Special conditions for use statement(s): Prescription use only 3
Limitations Perform an alternative method of testing prior to reporting of results for the following antibiotic/organism combinations: Imipenem (ipm05n): Klebsiella (Enterobacter) aerogenes, Proteus species, Providencia species, Morganella species and Serratia species. 4. Special instrument requirements: VITEK 2 and VITEK 2 Compact Systems I. Device Description: The VITEK® 2 AST card is a miniaturized, abbreviated and automated version of the doubling dilution technique for determining the minimum inhibitory concentration (MIC). Each VITEK® 2 AST card contains 64 wells. A control well(s) which contain only nutrient medium is resident on all cards. The remaining wells contain premeasured portions of antimicrobials combined with the nutrient media. The isolate to be tested is diluted to a standardized concentration with 0.45% to 0.50% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK 2 System will automatically dilute the bacterial suspension to prepare an inoculum for susceptibility cards. Then the VITEK® 2 will fill, seal and place the card into the incubator/reader. The VITEK 2 Compact has a manual filling, sealing and loading operation. The VITEK 2 Systems monitor the growth of each well in the card over a defined period of time (up to 24 hours for Streptococcus species). The analysis program determines when a well demonstrates growth based on attenuation of light measured by an optical scanner. This data is used to determine the minimum inhibitory concentration or MIC values for the anti-microbial agent. At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antimicrobial contained on the card. VITEK 2 AST-GN Imipenem has the following concentrations in the card: 0.5, 2, 8, and 16 µg/mL (equivalent standard method concentration by efficacy in µg/mL). The MIC result range for VITEK 2 AST-GN Imipenem on the VITEK 2 card is ≤ 0.25 - ≥ 16 µg/mL for Enterobacteriaceae and ≤ 0.5 - ≥ 16 µg/mL for Acinetobacter spp. and P. aeruginosa. J. Substantial Equivalence Information: 1. Predicate device name(s): VITEK 2 AST-GN Amikacin 2. Predicate 510(k) number(s): K172731 4
3. Comparison with predicate: Table 1. Comparison with the Predicate Device Similarities Item Device K183425 VITEK 2 AST-
GN Imipenem Predicate K172731 VITEK 2 AST-
GN Amikacin Intended Use VITEK 2 AST-Gram Negative Imipenem is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK 2 AST Gram Negative Imipenem is a quantitative test. Imipenem has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. Active in vitro and in clinical infections: Acinetobacter spp. Citrobacter spp. Enterobacter cloacae/E. cloacae complex Escherichia coli Klebsiella spp. Pseudomonas aeruginosa VITEK 2 AST Gram Negative Amikacin is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK 2 AST Gram Negative Amikacin is a quantitative test. Amikacin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. Active in vitro and in clinical infections: Pseudomonas spp. Escherichia coli Proteus mirabilis Klebsiella spp. Enterobacter spp. Serratia spp. Acinetobacter species (excluding A. baumannii Complex) In vitro data available but clinical significance is unknown: Citrobacter freundii Test Methodology Automated quantitative Same 5
Similarities
Item
Device
K183425 VITEK 2 AST-
GN Imipenem
Predicate K172731 VITEK 2 AST-
GN Amikacin antimicrobial susceptibility test for use with the VITEK 2 and VITEK 2 Compact Systems to determine the in vitro susceptibility of Gram negative bacilli Inoculum
Saline suspension of organism
Same Test Card
VITEK 2 Gram Negative Susceptibility Test Card
Same Instrument VITEK 2 and VITEK 2 Compact Same Analysis Algorithm
Growth Pattern Analysis
Same Differences
Item Device K183425 VITEK 2 AST-
GN Imipenem Predicate
K172731 VITEK 2 AST-
GN Amikacin
Antimicrobial Agent
Imipenem
Amikacin
Antimicrobial Concentrations
0.5, 2, 8, 16
2, 4, 16, 48
K. Standard/Guidance Document Referenced (if applicable):
CLSI Document M07-A10, Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard – Tenth Edition, Vol. 35, No. 2; January, 2015. Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems Guidance for Industry and FDA, August 2009. L. Test Principle: The VITEK® 2 and VITEK® 2 Compact Systems utilize automated growth-based detection using attenuation of light measured by an optical scanner. The optics used in the systems use visible light to directly measure organism growth. Transmittance optics are based on an initial light reading of a well before significant growth has begun. Periodic light transmittance samplings of the same well measure organism growth by how much light is prevented from going through the well. The VITEK 2 System monitors the growth of each well in the card over a defined period of time. An interpretive call is made between 4 and 16 6
hours for a “rapid” read but may be extended to 18 hours in some instances. At the completion of the incubation cycle, a report is generated that contains the MIC value
Panel: |
idK183415_s0_e2000 | K183415.txt | intended use | The VITEK 2 Gram-negative Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic Gram-negative bacilli to antimicrobial agents when used as instructed. | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K183415 B. Purpose for Submission: To obtain a substantial equivalence determination for imipenem at concentrations of 0.25 – 16 µg/mL for susceptibility testing of gram-negative aerobic organisms on the VITEK 2 and VITEK 2 Compact Antimicrobial Susceptibility Test (AST) Systems. C. Measurand: Imipenem 0.25 – 16 µg/mL D. Type of Test: Automated quantitative antimicrobial susceptibility (AST) E. Applicant: bioMérieux, Inc. F. Proprietary and Established Names: VITEK 2 AST-Gram Negative Imipenem (≤0.25 - ≥16 µg/mL) G. Regulatory Information: 1. Regulation section: 21 CFR 866.1645 Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System 2. Classification: Class II 3. Product code: LON – Fully automated short-term incubation cycle antimicrobial susceptibility system 2
LTW – Susceptibility Test Cards, Automated LTT – Panels, Test, Susceptibility, Automated 4. Panel: 83 Microbiology H. Intended Use: 1. Intended use(s): The VITEK 2 Gram-negative Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic Gram-negative bacilli to antimicrobial agents when used as instructed. 2. Indication(s) for use: VITEK 2 AST-Gram Negative Imipenem is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK 2 AST Gram Negative Imipenem is a quantitative test. Imipenem has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. Active in vitro and in clinical infections: Acinetobacter spp. Citrobacter spp. Enterobacter cloacae/E. cloacae complex Escherichia coli Klebsiella spp. Pseudomonas aeruginosa The VITEK 2 Gram-negative Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic Gram-negative bacilli to antimicrobial agents when used as instructed. 3. Special conditions for use statement(s): Prescription use only 3
Limitations Perform an alternative method of testing prior to reporting of results for the following antibiotic/organism combinations: Imipenem (ipm05n): Klebsiella (Enterobacter) aerogenes, Proteus species, Providencia species, Morganella species and Serratia species. 4. Special instrument requirements: VITEK 2 and VITEK 2 Compact Systems I. Device Description: The VITEK® 2 AST card is a miniaturized, abbreviated and automated version of the doubling dilution technique for determining the minimum inhibitory concentration (MIC). Each VITEK® 2 AST card contains 64 wells. A control well(s) which contain only nutrient medium is resident on all cards. The remaining wells contain premeasured portions of antimicrobials combined with the nutrient media. The isolate to be tested is diluted to a standardized concentration with 0.45% to 0.50% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK 2 System will automatically dilute the bacterial suspension to prepare an inoculum for susceptibility cards. Then the VITEK® 2 will fill, seal and place the card into the incubator/reader. The VITEK 2 Compact has a manual filling, sealing and loading operation. The VITEK 2 Systems monitor the growth of each well in the card over a defined period of time (up to 24 hours for Streptococcus species). The analysis program determines when a well demonstrates growth based on attenuation of light measured by an optical scanner. This data is used to determine the minimum inhibitory concentration or MIC values for the anti-microbial agent. At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antimicrobial contained on the card. VITEK 2 AST-GN Imipenem has the following concentrations in the card: 0.5, 2, 8, and 16 µg/mL (equivalent standard method concentration by efficacy in µg/mL). The MIC result range for VITEK 2 AST-GN Imipenem on the VITEK 2 card is ≤ 0.25 - ≥ 16 µg/mL for Enterobacteriaceae and ≤ 0.5 - ≥ 16 µg/mL for Acinetobacter spp. and P. aeruginosa. J. Substantial Equivalence Information: 1. Predicate device name(s): VITEK 2 AST-GN Amikacin 2. Predicate 510(k) number(s): K172731 4
3. Comparison with predicate: Table 1. Comparison with the Predicate Device Similarities Item Device K183425 VITEK 2 AST-
GN Imipenem Predicate K172731 VITEK 2 AST-
GN Amikacin Intended Use VITEK 2 AST-Gram Negative Imipenem is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK 2 AST Gram Negative Imipenem is a quantitative test. Imipenem has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. Active in vitro and in clinical infections: Acinetobacter spp. Citrobacter spp. Enterobacter cloacae/E. cloacae complex Escherichia coli Klebsiella spp. Pseudomonas aeruginosa VITEK 2 AST Gram Negative Amikacin is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK 2 AST Gram Negative Amikacin is a quantitative test. Amikacin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. Active in vitro and in clinical infections: Pseudomonas spp. Escherichia coli Proteus mirabilis Klebsiella spp. Enterobacter spp. Serratia spp. Acinetobacter species (excluding A. baumannii Complex) In vitro data available but clinical significance is unknown: Citrobacter freundii Test Methodology Automated quantitative Same 5
Similarities
Item
Device
K183425 VITEK 2 AST-
GN Imipenem
Predicate K172731 VITEK 2 AST-
GN Amikacin antimicrobial susceptibility test for use with the VITEK 2 and VITEK 2 Compact Systems to determine the in vitro susceptibility of Gram negative bacilli Inoculum
Saline suspension of organism
Same Test Card
VITEK 2 Gram Negative Susceptibility Test Card
Same Instrument VITEK 2 and VITEK 2 Compact Same Analysis Algorithm
Growth Pattern Analysis
Same Differences
Item Device K183425 VITEK 2 AST-
GN Imipenem Predicate
K172731 VITEK 2 AST-
GN Amikacin
Antimicrobial Agent
Imipenem
Amikacin
Antimicrobial Concentrations
0.5, 2, 8, 16
2, 4, 16, 48
K. Standard/Guidance Document Referenced (if applicable):
CLSI Document M07-A10, Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard – Tenth Edition, Vol. 35, No. 2; January, 2015. Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems Guidance for Industry and FDA, August 2009. L. Test Principle: The VITEK® 2 and VITEK® 2 Compact Systems utilize automated growth-based detection using attenuation of light measured by an optical scanner. The optics used in the systems use visible light to directly measure organism growth. Transmittance optics are based on an initial light reading of a well before significant growth has begun. Periodic light transmittance samplings of the same well measure organism growth by how much light is prevented from going through the well. The VITEK 2 System monitors the growth of each well in the card over a defined period of time. An interpretive call is made between 4 and 16 6
hours for a “rapid” read but may be extended to 18 hours in some instances. At the completion of the incubation cycle, a report is generated that contains the MIC value
Intended use: |
idK183415_s0_e2000 | K183415.txt | predicate device name | VITEK 2 AST-GN Amikacin | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K183415 B. Purpose for Submission: To obtain a substantial equivalence determination for imipenem at concentrations of 0.25 – 16 µg/mL for susceptibility testing of gram-negative aerobic organisms on the VITEK 2 and VITEK 2 Compact Antimicrobial Susceptibility Test (AST) Systems. C. Measurand: Imipenem 0.25 – 16 µg/mL D. Type of Test: Automated quantitative antimicrobial susceptibility (AST) E. Applicant: bioMérieux, Inc. F. Proprietary and Established Names: VITEK 2 AST-Gram Negative Imipenem (≤0.25 - ≥16 µg/mL) G. Regulatory Information: 1. Regulation section: 21 CFR 866.1645 Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System 2. Classification: Class II 3. Product code: LON – Fully automated short-term incubation cycle antimicrobial susceptibility system 2
LTW – Susceptibility Test Cards, Automated LTT – Panels, Test, Susceptibility, Automated 4. Panel: 83 Microbiology H. Intended Use: 1. Intended use(s): The VITEK 2 Gram-negative Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic Gram-negative bacilli to antimicrobial agents when used as instructed. 2. Indication(s) for use: VITEK 2 AST-Gram Negative Imipenem is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK 2 AST Gram Negative Imipenem is a quantitative test. Imipenem has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. Active in vitro and in clinical infections: Acinetobacter spp. Citrobacter spp. Enterobacter cloacae/E. cloacae complex Escherichia coli Klebsiella spp. Pseudomonas aeruginosa The VITEK 2 Gram-negative Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic Gram-negative bacilli to antimicrobial agents when used as instructed. 3. Special conditions for use statement(s): Prescription use only 3
Limitations Perform an alternative method of testing prior to reporting of results for the following antibiotic/organism combinations: Imipenem (ipm05n): Klebsiella (Enterobacter) aerogenes, Proteus species, Providencia species, Morganella species and Serratia species. 4. Special instrument requirements: VITEK 2 and VITEK 2 Compact Systems I. Device Description: The VITEK® 2 AST card is a miniaturized, abbreviated and automated version of the doubling dilution technique for determining the minimum inhibitory concentration (MIC). Each VITEK® 2 AST card contains 64 wells. A control well(s) which contain only nutrient medium is resident on all cards. The remaining wells contain premeasured portions of antimicrobials combined with the nutrient media. The isolate to be tested is diluted to a standardized concentration with 0.45% to 0.50% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK 2 System will automatically dilute the bacterial suspension to prepare an inoculum for susceptibility cards. Then the VITEK® 2 will fill, seal and place the card into the incubator/reader. The VITEK 2 Compact has a manual filling, sealing and loading operation. The VITEK 2 Systems monitor the growth of each well in the card over a defined period of time (up to 24 hours for Streptococcus species). The analysis program determines when a well demonstrates growth based on attenuation of light measured by an optical scanner. This data is used to determine the minimum inhibitory concentration or MIC values for the anti-microbial agent. At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antimicrobial contained on the card. VITEK 2 AST-GN Imipenem has the following concentrations in the card: 0.5, 2, 8, and 16 µg/mL (equivalent standard method concentration by efficacy in µg/mL). The MIC result range for VITEK 2 AST-GN Imipenem on the VITEK 2 card is ≤ 0.25 - ≥ 16 µg/mL for Enterobacteriaceae and ≤ 0.5 - ≥ 16 µg/mL for Acinetobacter spp. and P. aeruginosa. J. Substantial Equivalence Information: 1. Predicate device name(s): VITEK 2 AST-GN Amikacin 2. Predicate 510(k) number(s): K172731 4
3. Comparison with predicate: Table 1. Comparison with the Predicate Device Similarities Item Device K183425 VITEK 2 AST-
GN Imipenem Predicate K172731 VITEK 2 AST-
GN Amikacin Intended Use VITEK 2 AST-Gram Negative Imipenem is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK 2 AST Gram Negative Imipenem is a quantitative test. Imipenem has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. Active in vitro and in clinical infections: Acinetobacter spp. Citrobacter spp. Enterobacter cloacae/E. cloacae complex Escherichia coli Klebsiella spp. Pseudomonas aeruginosa VITEK 2 AST Gram Negative Amikacin is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK 2 AST Gram Negative Amikacin is a quantitative test. Amikacin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. Active in vitro and in clinical infections: Pseudomonas spp. Escherichia coli Proteus mirabilis Klebsiella spp. Enterobacter spp. Serratia spp. Acinetobacter species (excluding A. baumannii Complex) In vitro data available but clinical significance is unknown: Citrobacter freundii Test Methodology Automated quantitative Same 5
Similarities
Item
Device
K183425 VITEK 2 AST-
GN Imipenem
Predicate K172731 VITEK 2 AST-
GN Amikacin antimicrobial susceptibility test for use with the VITEK 2 and VITEK 2 Compact Systems to determine the in vitro susceptibility of Gram negative bacilli Inoculum
Saline suspension of organism
Same Test Card
VITEK 2 Gram Negative Susceptibility Test Card
Same Instrument VITEK 2 and VITEK 2 Compact Same Analysis Algorithm
Growth Pattern Analysis
Same Differences
Item Device K183425 VITEK 2 AST-
GN Imipenem Predicate
K172731 VITEK 2 AST-
GN Amikacin
Antimicrobial Agent
Imipenem
Amikacin
Antimicrobial Concentrations
0.5, 2, 8, 16
2, 4, 16, 48
K. Standard/Guidance Document Referenced (if applicable):
CLSI Document M07-A10, Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard – Tenth Edition, Vol. 35, No. 2; January, 2015. Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems Guidance for Industry and FDA, August 2009. L. Test Principle: The VITEK® 2 and VITEK® 2 Compact Systems utilize automated growth-based detection using attenuation of light measured by an optical scanner. The optics used in the systems use visible light to directly measure organism growth. Transmittance optics are based on an initial light reading of a well before significant growth has begun. Periodic light transmittance samplings of the same well measure organism growth by how much light is prevented from going through the well. The VITEK 2 System monitors the growth of each well in the card over a defined period of time. An interpretive call is made between 4 and 16 6
hours for a “rapid” read but may be extended to 18 hours in some instances. At the completion of the incubation cycle, a report is generated that contains the MIC value
Predicate device name: |
idK183415_s0_e2000 | K183415.txt | applicant | bioMérieux, Inc. | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K183415 B. Purpose for Submission: To obtain a substantial equivalence determination for imipenem at concentrations of 0.25 – 16 µg/mL for susceptibility testing of gram-negative aerobic organisms on the VITEK 2 and VITEK 2 Compact Antimicrobial Susceptibility Test (AST) Systems. C. Measurand: Imipenem 0.25 – 16 µg/mL D. Type of Test: Automated quantitative antimicrobial susceptibility (AST) E. Applicant: bioMérieux, Inc. F. Proprietary and Established Names: VITEK 2 AST-Gram Negative Imipenem (≤0.25 - ≥16 µg/mL) G. Regulatory Information: 1. Regulation section: 21 CFR 866.1645 Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System 2. Classification: Class II 3. Product code: LON – Fully automated short-term incubation cycle antimicrobial susceptibility system 2
LTW – Susceptibility Test Cards, Automated LTT – Panels, Test, Susceptibility, Automated 4. Panel: 83 Microbiology H. Intended Use: 1. Intended use(s): The VITEK 2 Gram-negative Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic Gram-negative bacilli to antimicrobial agents when used as instructed. 2. Indication(s) for use: VITEK 2 AST-Gram Negative Imipenem is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK 2 AST Gram Negative Imipenem is a quantitative test. Imipenem has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. Active in vitro and in clinical infections: Acinetobacter spp. Citrobacter spp. Enterobacter cloacae/E. cloacae complex Escherichia coli Klebsiella spp. Pseudomonas aeruginosa The VITEK 2 Gram-negative Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic Gram-negative bacilli to antimicrobial agents when used as instructed. 3. Special conditions for use statement(s): Prescription use only 3
Limitations Perform an alternative method of testing prior to reporting of results for the following antibiotic/organism combinations: Imipenem (ipm05n): Klebsiella (Enterobacter) aerogenes, Proteus species, Providencia species, Morganella species and Serratia species. 4. Special instrument requirements: VITEK 2 and VITEK 2 Compact Systems I. Device Description: The VITEK® 2 AST card is a miniaturized, abbreviated and automated version of the doubling dilution technique for determining the minimum inhibitory concentration (MIC). Each VITEK® 2 AST card contains 64 wells. A control well(s) which contain only nutrient medium is resident on all cards. The remaining wells contain premeasured portions of antimicrobials combined with the nutrient media. The isolate to be tested is diluted to a standardized concentration with 0.45% to 0.50% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK 2 System will automatically dilute the bacterial suspension to prepare an inoculum for susceptibility cards. Then the VITEK® 2 will fill, seal and place the card into the incubator/reader. The VITEK 2 Compact has a manual filling, sealing and loading operation. The VITEK 2 Systems monitor the growth of each well in the card over a defined period of time (up to 24 hours for Streptococcus species). The analysis program determines when a well demonstrates growth based on attenuation of light measured by an optical scanner. This data is used to determine the minimum inhibitory concentration or MIC values for the anti-microbial agent. At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antimicrobial contained on the card. VITEK 2 AST-GN Imipenem has the following concentrations in the card: 0.5, 2, 8, and 16 µg/mL (equivalent standard method concentration by efficacy in µg/mL). The MIC result range for VITEK 2 AST-GN Imipenem on the VITEK 2 card is ≤ 0.25 - ≥ 16 µg/mL for Enterobacteriaceae and ≤ 0.5 - ≥ 16 µg/mL for Acinetobacter spp. and P. aeruginosa. J. Substantial Equivalence Information: 1. Predicate device name(s): VITEK 2 AST-GN Amikacin 2. Predicate 510(k) number(s): K172731 4
3. Comparison with predicate: Table 1. Comparison with the Predicate Device Similarities Item Device K183425 VITEK 2 AST-
GN Imipenem Predicate K172731 VITEK 2 AST-
GN Amikacin Intended Use VITEK 2 AST-Gram Negative Imipenem is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK 2 AST Gram Negative Imipenem is a quantitative test. Imipenem has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. Active in vitro and in clinical infections: Acinetobacter spp. Citrobacter spp. Enterobacter cloacae/E. cloacae complex Escherichia coli Klebsiella spp. Pseudomonas aeruginosa VITEK 2 AST Gram Negative Amikacin is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK 2 AST Gram Negative Amikacin is a quantitative test. Amikacin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. Active in vitro and in clinical infections: Pseudomonas spp. Escherichia coli Proteus mirabilis Klebsiella spp. Enterobacter spp. Serratia spp. Acinetobacter species (excluding A. baumannii Complex) In vitro data available but clinical significance is unknown: Citrobacter freundii Test Methodology Automated quantitative Same 5
Similarities
Item
Device
K183425 VITEK 2 AST-
GN Imipenem
Predicate K172731 VITEK 2 AST-
GN Amikacin antimicrobial susceptibility test for use with the VITEK 2 and VITEK 2 Compact Systems to determine the in vitro susceptibility of Gram negative bacilli Inoculum
Saline suspension of organism
Same Test Card
VITEK 2 Gram Negative Susceptibility Test Card
Same Instrument VITEK 2 and VITEK 2 Compact Same Analysis Algorithm
Growth Pattern Analysis
Same Differences
Item Device K183425 VITEK 2 AST-
GN Imipenem Predicate
K172731 VITEK 2 AST-
GN Amikacin
Antimicrobial Agent
Imipenem
Amikacin
Antimicrobial Concentrations
0.5, 2, 8, 16
2, 4, 16, 48
K. Standard/Guidance Document Referenced (if applicable):
CLSI Document M07-A10, Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard – Tenth Edition, Vol. 35, No. 2; January, 2015. Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems Guidance for Industry and FDA, August 2009. L. Test Principle: The VITEK® 2 and VITEK® 2 Compact Systems utilize automated growth-based detection using attenuation of light measured by an optical scanner. The optics used in the systems use visible light to directly measure organism growth. Transmittance optics are based on an initial light reading of a well before significant growth has begun. Periodic light transmittance samplings of the same well measure organism growth by how much light is prevented from going through the well. The VITEK 2 System monitors the growth of each well in the card over a defined period of time. An interpretive call is made between 4 and 16 6
hours for a “rapid” read but may be extended to 18 hours in some instances. At the completion of the incubation cycle, a report is generated that contains the MIC value
Applicant: |
idK183415_s0_e2000 | K183415.txt | proprietary and established names | VITEK 2 AST-Gram Negative Imipenem (≤0.25 - ≥16 µg/mL) | ANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K183415 B. Purpose for Submission: To obtain a substantial equivalence determination for imipenem at concentrations of 0.25 – 16 µg/mL for susceptibility testing of gram-negative aerobic organisms on the VITEK 2 and VITEK 2 Compact Antimicrobial Susceptibility Test (AST) Systems. C. Measurand: Imipenem 0.25 – 16 µg/mL D. Type of Test: Automated quantitative antimicrobial susceptibility (AST) E. Applicant: bioMérieux, Inc. F. Proprietary and Established Names: VITEK 2 AST-Gram Negative Imipenem (≤0.25 - ≥16 µg/mL) G. Regulatory Information: 1. Regulation section: 21 CFR 866.1645 Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System 2. Classification: Class II 3. Product code: LON – Fully automated short-term incubation cycle antimicrobial susceptibility system 2
LTW – Susceptibility Test Cards, Automated LTT – Panels, Test, Susceptibility, Automated 4. Panel: 83 Microbiology H. Intended Use: 1. Intended use(s): The VITEK 2 Gram-negative Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic Gram-negative bacilli to antimicrobial agents when used as instructed. 2. Indication(s) for use: VITEK 2 AST-Gram Negative Imipenem is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK 2 AST Gram Negative Imipenem is a quantitative test. Imipenem has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. Active in vitro and in clinical infections: Acinetobacter spp. Citrobacter spp. Enterobacter cloacae/E. cloacae complex Escherichia coli Klebsiella spp. Pseudomonas aeruginosa The VITEK 2 Gram-negative Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic Gram-negative bacilli to antimicrobial agents when used as instructed. 3. Special conditions for use statement(s): Prescription use only 3
Limitations Perform an alternative method of testing prior to reporting of results for the following antibiotic/organism combinations: Imipenem (ipm05n): Klebsiella (Enterobacter) aerogenes, Proteus species, Providencia species, Morganella species and Serratia species. 4. Special instrument requirements: VITEK 2 and VITEK 2 Compact Systems I. Device Description: The VITEK® 2 AST card is a miniaturized, abbreviated and automated version of the doubling dilution technique for determining the minimum inhibitory concentration (MIC). Each VITEK® 2 AST card contains 64 wells. A control well(s) which contain only nutrient medium is resident on all cards. The remaining wells contain premeasured portions of antimicrobials combined with the nutrient media. The isolate to be tested is diluted to a standardized concentration with 0.45% to 0.50% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK 2 System will automatically dilute the bacterial suspension to prepare an inoculum for susceptibility cards. Then the VITEK® 2 will fill, seal and place the card into the incubator/reader. The VITEK 2 Compact has a manual filling, sealing and loading operation. The VITEK 2 Systems monitor the growth of each well in the card over a defined period of time (up to 24 hours for Streptococcus species). The analysis program determines when a well demonstrates growth based on attenuation of light measured by an optical scanner. This data is used to determine the minimum inhibitory concentration or MIC values for the anti-microbial agent. At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antimicrobial contained on the card. VITEK 2 AST-GN Imipenem has the following concentrations in the card: 0.5, 2, 8, and 16 µg/mL (equivalent standard method concentration by efficacy in µg/mL). The MIC result range for VITEK 2 AST-GN Imipenem on the VITEK 2 card is ≤ 0.25 - ≥ 16 µg/mL for Enterobacteriaceae and ≤ 0.5 - ≥ 16 µg/mL for Acinetobacter spp. and P. aeruginosa. J. Substantial Equivalence Information: 1. Predicate device name(s): VITEK 2 AST-GN Amikacin 2. Predicate 510(k) number(s): K172731 4
3. Comparison with predicate: Table 1. Comparison with the Predicate Device Similarities Item Device K183425 VITEK 2 AST-
GN Imipenem Predicate K172731 VITEK 2 AST-
GN Amikacin Intended Use VITEK 2 AST-Gram Negative Imipenem is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK 2 AST Gram Negative Imipenem is a quantitative test. Imipenem has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. Active in vitro and in clinical infections: Acinetobacter spp. Citrobacter spp. Enterobacter cloacae/E. cloacae complex Escherichia coli Klebsiella spp. Pseudomonas aeruginosa VITEK 2 AST Gram Negative Amikacin is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK 2 AST Gram Negative Amikacin is a quantitative test. Amikacin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. Active in vitro and in clinical infections: Pseudomonas spp. Escherichia coli Proteus mirabilis Klebsiella spp. Enterobacter spp. Serratia spp. Acinetobacter species (excluding A. baumannii Complex) In vitro data available but clinical significance is unknown: Citrobacter freundii Test Methodology Automated quantitative Same 5
Similarities
Item
Device
K183425 VITEK 2 AST-
GN Imipenem
Predicate K172731 VITEK 2 AST-
GN Amikacin antimicrobial susceptibility test for use with the VITEK 2 and VITEK 2 Compact Systems to determine the in vitro susceptibility of Gram negative bacilli Inoculum
Saline suspension of organism
Same Test Card
VITEK 2 Gram Negative Susceptibility Test Card
Same Instrument VITEK 2 and VITEK 2 Compact Same Analysis Algorithm
Growth Pattern Analysis
Same Differences
Item Device K183425 VITEK 2 AST-
GN Imipenem Predicate
K172731 VITEK 2 AST-
GN Amikacin
Antimicrobial Agent
Imipenem
Amikacin
Antimicrobial Concentrations
0.5, 2, 8, 16
2, 4, 16, 48
K. Standard/Guidance Document Referenced (if applicable):
CLSI Document M07-A10, Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard – Tenth Edition, Vol. 35, No. 2; January, 2015. Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems Guidance for Industry and FDA, August 2009. L. Test Principle: The VITEK® 2 and VITEK® 2 Compact Systems utilize automated growth-based detection using attenuation of light measured by an optical scanner. The optics used in the systems use visible light to directly measure organism growth. Transmittance optics are based on an initial light reading of a well before significant growth has begun. Periodic light transmittance samplings of the same well measure organism growth by how much light is prevented from going through the well. The VITEK 2 System monitors the growth of each well in the card over a defined period of time. An interpretive call is made between 4 and 16 6
hours for a “rapid” read but may be extended to 18 hours in some instances. At the completion of the incubation cycle, a report is generated that contains the MIC value
Proprietary and established names: |
idK183415_s0_e2000 | K183415.txt | regulation section | 21 CFR 866.1645 Fully Automated Short-Term Incubation Cycle Antimicrobial | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K183415 B. Purpose for Submission: To obtain a substantial equivalence determination for imipenem at concentrations of 0.25 – 16 µg/mL for susceptibility testing of gram-negative aerobic organisms on the VITEK 2 and VITEK 2 Compact Antimicrobial Susceptibility Test (AST) Systems. C. Measurand: Imipenem 0.25 – 16 µg/mL D. Type of Test: Automated quantitative antimicrobial susceptibility (AST) E. Applicant: bioMérieux, Inc. F. Proprietary and Established Names: VITEK 2 AST-Gram Negative Imipenem (≤0.25 - ≥16 µg/mL) G. Regulatory Information: 1. Regulation section: 21 CFR 866.1645 Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System 2. Classification: Class II 3. Product code: LON – Fully automated short-term incubation cycle antimicrobial susceptibility system 2
LTW – Susceptibility Test Cards, Automated LTT – Panels, Test, Susceptibility, Automated 4. Panel: 83 Microbiology H. Intended Use: 1. Intended use(s): The VITEK 2 Gram-negative Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic Gram-negative bacilli to antimicrobial agents when used as instructed. 2. Indication(s) for use: VITEK 2 AST-Gram Negative Imipenem is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK 2 AST Gram Negative Imipenem is a quantitative test. Imipenem has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. Active in vitro and in clinical infections: Acinetobacter spp. Citrobacter spp. Enterobacter cloacae/E. cloacae complex Escherichia coli Klebsiella spp. Pseudomonas aeruginosa The VITEK 2 Gram-negative Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic Gram-negative bacilli to antimicrobial agents when used as instructed. 3. Special conditions for use statement(s): Prescription use only 3
Limitations Perform an alternative method of testing prior to reporting of results for the following antibiotic/organism combinations: Imipenem (ipm05n): Klebsiella (Enterobacter) aerogenes, Proteus species, Providencia species, Morganella species and Serratia species. 4. Special instrument requirements: VITEK 2 and VITEK 2 Compact Systems I. Device Description: The VITEK® 2 AST card is a miniaturized, abbreviated and automated version of the doubling dilution technique for determining the minimum inhibitory concentration (MIC). Each VITEK® 2 AST card contains 64 wells. A control well(s) which contain only nutrient medium is resident on all cards. The remaining wells contain premeasured portions of antimicrobials combined with the nutrient media. The isolate to be tested is diluted to a standardized concentration with 0.45% to 0.50% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK 2 System will automatically dilute the bacterial suspension to prepare an inoculum for susceptibility cards. Then the VITEK® 2 will fill, seal and place the card into the incubator/reader. The VITEK 2 Compact has a manual filling, sealing and loading operation. The VITEK 2 Systems monitor the growth of each well in the card over a defined period of time (up to 24 hours for Streptococcus species). The analysis program determines when a well demonstrates growth based on attenuation of light measured by an optical scanner. This data is used to determine the minimum inhibitory concentration or MIC values for the anti-microbial agent. At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antimicrobial contained on the card. VITEK 2 AST-GN Imipenem has the following concentrations in the card: 0.5, 2, 8, and 16 µg/mL (equivalent standard method concentration by efficacy in µg/mL). The MIC result range for VITEK 2 AST-GN Imipenem on the VITEK 2 card is ≤ 0.25 - ≥ 16 µg/mL for Enterobacteriaceae and ≤ 0.5 - ≥ 16 µg/mL for Acinetobacter spp. and P. aeruginosa. J. Substantial Equivalence Information: 1. Predicate device name(s): VITEK 2 AST-GN Amikacin 2. Predicate 510(k) number(s): K172731 4
3. Comparison with predicate: Table 1. Comparison with the Predicate Device Similarities Item Device K183425 VITEK 2 AST-
GN Imipenem Predicate K172731 VITEK 2 AST-
GN Amikacin Intended Use VITEK 2 AST-Gram Negative Imipenem is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK 2 AST Gram Negative Imipenem is a quantitative test. Imipenem has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. Active in vitro and in clinical infections: Acinetobacter spp. Citrobacter spp. Enterobacter cloacae/E. cloacae complex Escherichia coli Klebsiella spp. Pseudomonas aeruginosa VITEK 2 AST Gram Negative Amikacin is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK 2 and VITEK 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK 2 AST Gram Negative Amikacin is a quantitative test. Amikacin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. Active in vitro and in clinical infections: Pseudomonas spp. Escherichia coli Proteus mirabilis Klebsiella spp. Enterobacter spp. Serratia spp. Acinetobacter species (excluding A. baumannii Complex) In vitro data available but clinical significance is unknown: Citrobacter freundii Test Methodology Automated quantitative Same 5
Similarities
Item
Device
K183425 VITEK 2 AST-
GN Imipenem
Predicate K172731 VITEK 2 AST-
GN Amikacin antimicrobial susceptibility test for use with the VITEK 2 and VITEK 2 Compact Systems to determine the in vitro susceptibility of Gram negative bacilli Inoculum
Saline suspension of organism
Same Test Card
VITEK 2 Gram Negative Susceptibility Test Card
Same Instrument VITEK 2 and VITEK 2 Compact Same Analysis Algorithm
Growth Pattern Analysis
Same Differences
Item Device K183425 VITEK 2 AST-
GN Imipenem Predicate
K172731 VITEK 2 AST-
GN Amikacin
Antimicrobial Agent
Imipenem
Amikacin
Antimicrobial Concentrations
0.5, 2, 8, 16
2, 4, 16, 48
K. Standard/Guidance Document Referenced (if applicable):
CLSI Document M07-A10, Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard – Tenth Edition, Vol. 35, No. 2; January, 2015. Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems Guidance for Industry and FDA, August 2009. L. Test Principle: The VITEK® 2 and VITEK® 2 Compact Systems utilize automated growth-based detection using attenuation of light measured by an optical scanner. The optics used in the systems use visible light to directly measure organism growth. Transmittance optics are based on an initial light reading of a well before significant growth has begun. Periodic light transmittance samplings of the same well measure organism growth by how much light is prevented from going through the well. The VITEK 2 System monitors the growth of each well in the card over a defined period of time. An interpretive call is made between 4 and 16 6
hours for a “rapid” read but may be extended to 18 hours in some instances. At the completion of the incubation cycle, a report is generated that contains the MIC value
Regulation section: |
idK183415_s6000_e8000 | K183415.txt | proposed labeling | The labeling supports the finding of substantial equivalence for this device | 20.0) 0 No Citrobacter spp. 0 - - - - - E. cloacae/E. cloacae complex 15 0 7 (46.7) 8 (53.3) 53.3 (22.4-75.2) Yes E. coli 3 0 1 (33.3) 2 (66.7) 66.7 (-5.9-93.9) Yesa Klebsiella spp. 46 20 (43.5) 22 (47.8) 4 (8.7) -34.8 (-5.0- -17.1) Yes Enterobacteriaceae 64 20 (31.2) 30 (46.9) 14 (21.9) -9.4 No P. aeruginosa 22 6 (27.3) 9 (40.9) 7 (31.8) 4.6 No a Not statistically significant b. Matrix comparison: N/A 3. Clinical studies: a. Clinical Sensitivity: N/A 13
b. Clinical specificity: N/A c. Other clinical supportive data (when a. and b. are not applicable): N/A 4. Clinical cut-off: N/A 5. Expected values/Reference range: Table 7. Interpretive Categories for Imipenem (FDA STIC Webpage and CLSI M100) Organism Interpretive Categories for Imipenem MIC (µg/mL)a S I R Enterobacteriaceae ≤ 1 2 ≥ 4 P. aeruginosa ≤ 2 4 ≥ 8 Acinetobacter spp. ≤ 2 4 ≥ 8 a FDA STIC Webpage https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm4
10971.htm N. Proposed Labeling: The labeling supports the finding of substantial equivalence for this device O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
Proposed labeling: |
idK183415_s6000_e8000 | K183415.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | 1 (20.0) 0 No Citrobacter spp. 0 - - - - - E. cloacae/E. cloacae complex 15 0 7 (46.7) 8 (53.3) 53.3 (22.4-75.2) Yes E. coli 3 0 1 (33.3) 2 (66.7) 66.7 (-5.9-93.9) Yesa Klebsiella spp. 46 20 (43.5) 22 (47.8) 4 (8.7) -34.8 (-5.0- -17.1) Yes Enterobacteriaceae 64 20 (31.2) 30 (46.9) 14 (21.9) -9.4 No P. aeruginosa 22 6 (27.3) 9 (40.9) 7 (31.8) 4.6 No a Not statistically significant b. Matrix comparison: N/A 3. Clinical studies: a. Clinical Sensitivity: N/A 13
b. Clinical specificity: N/A c. Other clinical supportive data (when a. and b. are not applicable): N/A 4. Clinical cut-off: N/A 5. Expected values/Reference range: Table 7. Interpretive Categories for Imipenem (FDA STIC Webpage and CLSI M100) Organism Interpretive Categories for Imipenem MIC (µg/mL)a S I R Enterobacteriaceae ≤ 1 2 ≥ 4 P. aeruginosa ≤ 2 4 ≥ 8 Acinetobacter spp. ≤ 2 4 ≥ 8 a FDA STIC Webpage https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm4
10971.htm N. Proposed Labeling: The labeling supports the finding of substantial equivalence for this device O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
Conclusion: |
idK151923_s0_e2000 | K151923.txt | purpose for submission | To obtain a substantial equivalence determination for the addition of Micafungin to the VITEK® 2 and VITEK® 2 Compact Systems Antimicrobial Susceptibility Test (AST) Systems | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K151923 B. Purpose for Submission: To obtain a substantial equivalence determination for the addition of Micafungin to the VITEK® 2 and VITEK® 2 Compact Systems Antimicrobial Susceptibility Test (AST) Systems C. Measurand: The VITEK 2 AST Yeast card contains the following concentration of Micafungin: 0.06, 0.25, 1 and 4μg/mL. The MIC result reporting range for the VITEK 2 card is ≤ 0.06 - ≥8 µg/ml. D. Type of Test: Automated quantitative or qualitative antifungal susceptibility test of Candida species to Micafungin E. Applicant: bioMérieux, Inc. F. Proprietary and Established Names: VITEK® 2 AST-Yeast Micafungin (0.06 - 8 µg/mL) G. Regulatory Information: 1. Regulation section: 21 CFR 866.1640, Antimicrobial Susceptibility Test Powder 2. Classification: II 3. Product code: NGZ – Susceptibility Test Plate, Antifungal 2 LRG – Instrument for Auto Reader and Interpretation of Overnight Susceptibility Systems LTT – Panels, Test, Susceptibility, Antimicrobial LTW – Susceptibility Test Cards, Antimicrobial 4. Panel: 83 Microbiology H. Intended Use: 1. Intended use (s): The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast. 2. Indication(s) for use: VITEK® 2 Yeast Micafungin is designed for antifungal susceptibility testing of Candida species. VITEK® 2 Yeast Micafungin is a quantitative test intended for use with the VITEK® 2 COMPACT Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 Yeast Micafungin has been shown to be active against most isolates of the microorganisms listed below, according to the FDA label for this antifungal. Active in vitro and in clinical infections Candida albicans Candida glabrata Candida guilliermondii Candida krusei Candida parapsilosis Candida tropicalis The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. S. pneumoniae, and clinically significant yeast. 3 3. Special conditions for use statement(s): For prescription use only The following limitations are included in the device labeling: “The ability of the AST card to detect resistance with the following combination(s) is unknown because an insufficient number of resistant strains were available at the time of comparative testing. If such a strain is observed, it should be submitted to a reference laboratory for further testing: Micafungin: Candida glabrata” “The ability of the AST card to detect resistance with the following combination(s) is unknown because resistant strains were not available at the time of comparative testing: Micafungin: Candida spp” 4. Special instrument requirements: For use with the VITEK® 2 and VITEK® 2 Compact Systems I. Device Description: The VITEK® 2 AST card is a miniaturized, abbreviated and automated version of the doubling dilution technique for determining the minimum inhibitory concentration (MIC). Each VITEK® 2 test card contains 64 microwells. A control well containing only culture medium is included on all cards, with the remaining wells containing premeasured amounts of a specific antimicrobial agent in a culture medium base. A suspension of organism from a pure culture is prepared in a tube containing 0.45-0.5% sterile saline and standardized to a McFarland 0.5 using the DensiCHEK Plus™. The VITEK 2 System automatically fills, seals and places the card into the incubator/reader; manual methods can also be used for the inoculation of test cards for use in the VITEK 2 System. The VITEK 2 Compact has a manual filling, sealing and loading operation. The VITEK 2 Systems monitor the growth of each well in the card over a defined period of time. At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antimicrobial contained on the card. The VITEK® 2 AST-Yeast Micafungin has the following concentrations in the card: 0.06, 0.25, 1 and 4 μg/mL (equivalent standard method concentration by efficacy in μg/mL). The MIC result range for the VITEK® 2 card is ≤0.06-≥8 µg/ml. J. Substantial Equivalence Information: 1. Predicate device name(s): VITEK® 2 AST-YST Flucytosine 4 2. Predicate 510(k) number(s): K133952 3. Comparison with predicate: Similarities Item Device VITEK 2 AST-
Yeast Micafungin Predicate VITEK 2 AST-
YS Flucytosine (K133952) Intended Use VITEK2 Yeast Micafungin is designed for antifungal susceptibility testing of Candida species. Vitek 2 Yeast Micafungin is a quantitative test intended for use with the VITEK 2 and VITEK 2 COMPACT Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. Same Test Methodology Automated yeast antifungal susceptibility test for use with the VITEK 2 and VITEK 2 Compact Systems (VITEK 2 Systems) to determine the in vitro susceptibility of Candida species. Same Inoculum Saline suspension of organism Same Test Card VITEK 2 Antifungal Susceptibility Test Card Same Instrument VITEK 2 and VITEK 2 Compact Systems Same Analysis algorithm Discriminate Analysis Same Differences Item Device Predicate Antimicrobial Agent Micafungin Flucytosine Antimicrobial Concentrations 0.06, 0.25, 1, 4 1, 4, 16, 32 K. Standard/Guidance Document Referenced (if applicable): CLSI Document M27-A3, Reference Method for Broth Dilution Antifungal Susceptibility 5 Testing of Yeasts; Approved Standard-Third Edition, Vol. 28 No.14 CLSI Document M27-S4, Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Fourth Informational Supplement, Vol.32 No. 17 L. Test Principle: The VITEK® 2 System optics use visible light to directly measure organism growth. The transmittance optics are based on an initial light reading of a well before significant growth has begun. Periodic light transmittance samplings of the same well measure organism growth by how much light is prevented from going through the well. Several parameters based on the growth characteristics observed are used to provide appropriate input for the MIC calculations. Discriminate analysis is used to develop the algorithm that determines the susceptibility result for all antimicrobials on the VITEK® 2 System. The MIC result must be linked to organism identification in order to determine a category interpretation. A category interpretation (SIR) will be reported along with each MIC result. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Reproducibility studies included both the auto- and manual dilution methods with the VITEK 2 instrument system and the manual dilution method with the VITEK 2 Compact instrument system. With each inoculation method, the mode MIC was determined for each isolate and the reproducibility was calculated based on MIC values falling within ± 1 dilution of the mode MIC. Testing using VITEK 2 and automatic dilution was performed using 10 Candida isolates (four isolates of C. parapsilosis, two C. krusei, two C. norvegensis, and two C. gulliermondii). Testing was done in triplicates at three clinical sites (two external sites and one internal site) on three separate days. All MIC values were on-scale and reproducibility demonstrated acceptable performance at 100%. Initial studies using both the VITEK 2 and the VITEK 2 Compact and manual dilution did not meet acceptable reproducibility performance particularly due to C. guillermondii. Per FDA’s request, an additional study was performed using five isolates of C. guillermondii with on-scale Micafungin MIC values. These isolates were tested in triplicate on three separate days at three sites and included a total of 45 data points at each site. The best and worst case reproducibility for VITEK 2 and VITE
Purpose for submission: |
idK151923_s0_e2000 | K151923.txt | type of test | Automated quantitative or qualitative antifungal susceptibility test of Candida species to Micafungin | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K151923 B. Purpose for Submission: To obtain a substantial equivalence determination for the addition of Micafungin to the VITEK® 2 and VITEK® 2 Compact Systems Antimicrobial Susceptibility Test (AST) Systems C. Measurand: The VITEK 2 AST Yeast card contains the following concentration of Micafungin: 0.06, 0.25, 1 and 4μg/mL. The MIC result reporting range for the VITEK 2 card is ≤ 0.06 - ≥8 µg/ml. D. Type of Test: Automated quantitative or qualitative antifungal susceptibility test of Candida species to Micafungin E. Applicant: bioMérieux, Inc. F. Proprietary and Established Names: VITEK® 2 AST-Yeast Micafungin (0.06 - 8 µg/mL) G. Regulatory Information: 1. Regulation section: 21 CFR 866.1640, Antimicrobial Susceptibility Test Powder 2. Classification: II 3. Product code: NGZ – Susceptibility Test Plate, Antifungal 2 LRG – Instrument for Auto Reader and Interpretation of Overnight Susceptibility Systems LTT – Panels, Test, Susceptibility, Antimicrobial LTW – Susceptibility Test Cards, Antimicrobial 4. Panel: 83 Microbiology H. Intended Use: 1. Intended use (s): The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast. 2. Indication(s) for use: VITEK® 2 Yeast Micafungin is designed for antifungal susceptibility testing of Candida species. VITEK® 2 Yeast Micafungin is a quantitative test intended for use with the VITEK® 2 COMPACT Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 Yeast Micafungin has been shown to be active against most isolates of the microorganisms listed below, according to the FDA label for this antifungal. Active in vitro and in clinical infections Candida albicans Candida glabrata Candida guilliermondii Candida krusei Candida parapsilosis Candida tropicalis The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. S. pneumoniae, and clinically significant yeast. 3 3. Special conditions for use statement(s): For prescription use only The following limitations are included in the device labeling: “The ability of the AST card to detect resistance with the following combination(s) is unknown because an insufficient number of resistant strains were available at the time of comparative testing. If such a strain is observed, it should be submitted to a reference laboratory for further testing: Micafungin: Candida glabrata” “The ability of the AST card to detect resistance with the following combination(s) is unknown because resistant strains were not available at the time of comparative testing: Micafungin: Candida spp” 4. Special instrument requirements: For use with the VITEK® 2 and VITEK® 2 Compact Systems I. Device Description: The VITEK® 2 AST card is a miniaturized, abbreviated and automated version of the doubling dilution technique for determining the minimum inhibitory concentration (MIC). Each VITEK® 2 test card contains 64 microwells. A control well containing only culture medium is included on all cards, with the remaining wells containing premeasured amounts of a specific antimicrobial agent in a culture medium base. A suspension of organism from a pure culture is prepared in a tube containing 0.45-0.5% sterile saline and standardized to a McFarland 0.5 using the DensiCHEK Plus™. The VITEK 2 System automatically fills, seals and places the card into the incubator/reader; manual methods can also be used for the inoculation of test cards for use in the VITEK 2 System. The VITEK 2 Compact has a manual filling, sealing and loading operation. The VITEK 2 Systems monitor the growth of each well in the card over a defined period of time. At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antimicrobial contained on the card. The VITEK® 2 AST-Yeast Micafungin has the following concentrations in the card: 0.06, 0.25, 1 and 4 μg/mL (equivalent standard method concentration by efficacy in μg/mL). The MIC result range for the VITEK® 2 card is ≤0.06-≥8 µg/ml. J. Substantial Equivalence Information: 1. Predicate device name(s): VITEK® 2 AST-YST Flucytosine 4 2. Predicate 510(k) number(s): K133952 3. Comparison with predicate: Similarities Item Device VITEK 2 AST-
Yeast Micafungin Predicate VITEK 2 AST-
YS Flucytosine (K133952) Intended Use VITEK2 Yeast Micafungin is designed for antifungal susceptibility testing of Candida species. Vitek 2 Yeast Micafungin is a quantitative test intended for use with the VITEK 2 and VITEK 2 COMPACT Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. Same Test Methodology Automated yeast antifungal susceptibility test for use with the VITEK 2 and VITEK 2 Compact Systems (VITEK 2 Systems) to determine the in vitro susceptibility of Candida species. Same Inoculum Saline suspension of organism Same Test Card VITEK 2 Antifungal Susceptibility Test Card Same Instrument VITEK 2 and VITEK 2 Compact Systems Same Analysis algorithm Discriminate Analysis Same Differences Item Device Predicate Antimicrobial Agent Micafungin Flucytosine Antimicrobial Concentrations 0.06, 0.25, 1, 4 1, 4, 16, 32 K. Standard/Guidance Document Referenced (if applicable): CLSI Document M27-A3, Reference Method for Broth Dilution Antifungal Susceptibility 5 Testing of Yeasts; Approved Standard-Third Edition, Vol. 28 No.14 CLSI Document M27-S4, Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Fourth Informational Supplement, Vol.32 No. 17 L. Test Principle: The VITEK® 2 System optics use visible light to directly measure organism growth. The transmittance optics are based on an initial light reading of a well before significant growth has begun. Periodic light transmittance samplings of the same well measure organism growth by how much light is prevented from going through the well. Several parameters based on the growth characteristics observed are used to provide appropriate input for the MIC calculations. Discriminate analysis is used to develop the algorithm that determines the susceptibility result for all antimicrobials on the VITEK® 2 System. The MIC result must be linked to organism identification in order to determine a category interpretation. A category interpretation (SIR) will be reported along with each MIC result. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Reproducibility studies included both the auto- and manual dilution methods with the VITEK 2 instrument system and the manual dilution method with the VITEK 2 Compact instrument system. With each inoculation method, the mode MIC was determined for each isolate and the reproducibility was calculated based on MIC values falling within ± 1 dilution of the mode MIC. Testing using VITEK 2 and automatic dilution was performed using 10 Candida isolates (four isolates of C. parapsilosis, two C. krusei, two C. norvegensis, and two C. gulliermondii). Testing was done in triplicates at three clinical sites (two external sites and one internal site) on three separate days. All MIC values were on-scale and reproducibility demonstrated acceptable performance at 100%. Initial studies using both the VITEK 2 and the VITEK 2 Compact and manual dilution did not meet acceptable reproducibility performance particularly due to C. guillermondii. Per FDA’s request, an additional study was performed using five isolates of C. guillermondii with on-scale Micafungin MIC values. These isolates were tested in triplicate on three separate days at three sites and included a total of 45 data points at each site. The best and worst case reproducibility for VITEK 2 and VITE
Type of test: |
idK151923_s0_e2000 | K151923.txt | classification | II | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K151923 B. Purpose for Submission: To obtain a substantial equivalence determination for the addition of Micafungin to the VITEK® 2 and VITEK® 2 Compact Systems Antimicrobial Susceptibility Test (AST) Systems C. Measurand: The VITEK 2 AST Yeast card contains the following concentration of Micafungin: 0.06, 0.25, 1 and 4μg/mL. The MIC result reporting range for the VITEK 2 card is ≤ 0.06 - ≥8 µg/ml. D. Type of Test: Automated quantitative or qualitative antifungal susceptibility test of Candida species to Micafungin E. Applicant: bioMérieux, Inc. F. Proprietary and Established Names: VITEK® 2 AST-Yeast Micafungin (0.06 - 8 µg/mL) G. Regulatory Information: 1. Regulation section: 21 CFR 866.1640, Antimicrobial Susceptibility Test Powder 2. Classification: II 3. Product code: NGZ – Susceptibility Test Plate, Antifungal 2 LRG – Instrument for Auto Reader and Interpretation of Overnight Susceptibility Systems LTT – Panels, Test, Susceptibility, Antimicrobial LTW – Susceptibility Test Cards, Antimicrobial 4. Panel: 83 Microbiology H. Intended Use: 1. Intended use (s): The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast. 2. Indication(s) for use: VITEK® 2 Yeast Micafungin is designed for antifungal susceptibility testing of Candida species. VITEK® 2 Yeast Micafungin is a quantitative test intended for use with the VITEK® 2 COMPACT Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 Yeast Micafungin has been shown to be active against most isolates of the microorganisms listed below, according to the FDA label for this antifungal. Active in vitro and in clinical infections Candida albicans Candida glabrata Candida guilliermondii Candida krusei Candida parapsilosis Candida tropicalis The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. S. pneumoniae, and clinically significant yeast. 3 3. Special conditions for use statement(s): For prescription use only The following limitations are included in the device labeling: “The ability of the AST card to detect resistance with the following combination(s) is unknown because an insufficient number of resistant strains were available at the time of comparative testing. If such a strain is observed, it should be submitted to a reference laboratory for further testing: Micafungin: Candida glabrata” “The ability of the AST card to detect resistance with the following combination(s) is unknown because resistant strains were not available at the time of comparative testing: Micafungin: Candida spp” 4. Special instrument requirements: For use with the VITEK® 2 and VITEK® 2 Compact Systems I. Device Description: The VITEK® 2 AST card is a miniaturized, abbreviated and automated version of the doubling dilution technique for determining the minimum inhibitory concentration (MIC). Each VITEK® 2 test card contains 64 microwells. A control well containing only culture medium is included on all cards, with the remaining wells containing premeasured amounts of a specific antimicrobial agent in a culture medium base. A suspension of organism from a pure culture is prepared in a tube containing 0.45-0.5% sterile saline and standardized to a McFarland 0.5 using the DensiCHEK Plus™. The VITEK 2 System automatically fills, seals and places the card into the incubator/reader; manual methods can also be used for the inoculation of test cards for use in the VITEK 2 System. The VITEK 2 Compact has a manual filling, sealing and loading operation. The VITEK 2 Systems monitor the growth of each well in the card over a defined period of time. At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antimicrobial contained on the card. The VITEK® 2 AST-Yeast Micafungin has the following concentrations in the card: 0.06, 0.25, 1 and 4 μg/mL (equivalent standard method concentration by efficacy in μg/mL). The MIC result range for the VITEK® 2 card is ≤0.06-≥8 µg/ml. J. Substantial Equivalence Information: 1. Predicate device name(s): VITEK® 2 AST-YST Flucytosine 4 2. Predicate 510(k) number(s): K133952 3. Comparison with predicate: Similarities Item Device VITEK 2 AST-
Yeast Micafungin Predicate VITEK 2 AST-
YS Flucytosine (K133952) Intended Use VITEK2 Yeast Micafungin is designed for antifungal susceptibility testing of Candida species. Vitek 2 Yeast Micafungin is a quantitative test intended for use with the VITEK 2 and VITEK 2 COMPACT Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. Same Test Methodology Automated yeast antifungal susceptibility test for use with the VITEK 2 and VITEK 2 Compact Systems (VITEK 2 Systems) to determine the in vitro susceptibility of Candida species. Same Inoculum Saline suspension of organism Same Test Card VITEK 2 Antifungal Susceptibility Test Card Same Instrument VITEK 2 and VITEK 2 Compact Systems Same Analysis algorithm Discriminate Analysis Same Differences Item Device Predicate Antimicrobial Agent Micafungin Flucytosine Antimicrobial Concentrations 0.06, 0.25, 1, 4 1, 4, 16, 32 K. Standard/Guidance Document Referenced (if applicable): CLSI Document M27-A3, Reference Method for Broth Dilution Antifungal Susceptibility 5 Testing of Yeasts; Approved Standard-Third Edition, Vol. 28 No.14 CLSI Document M27-S4, Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Fourth Informational Supplement, Vol.32 No. 17 L. Test Principle: The VITEK® 2 System optics use visible light to directly measure organism growth. The transmittance optics are based on an initial light reading of a well before significant growth has begun. Periodic light transmittance samplings of the same well measure organism growth by how much light is prevented from going through the well. Several parameters based on the growth characteristics observed are used to provide appropriate input for the MIC calculations. Discriminate analysis is used to develop the algorithm that determines the susceptibility result for all antimicrobials on the VITEK® 2 System. The MIC result must be linked to organism identification in order to determine a category interpretation. A category interpretation (SIR) will be reported along with each MIC result. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Reproducibility studies included both the auto- and manual dilution methods with the VITEK 2 instrument system and the manual dilution method with the VITEK 2 Compact instrument system. With each inoculation method, the mode MIC was determined for each isolate and the reproducibility was calculated based on MIC values falling within ± 1 dilution of the mode MIC. Testing using VITEK 2 and automatic dilution was performed using 10 Candida isolates (four isolates of C. parapsilosis, two C. krusei, two C. norvegensis, and two C. gulliermondii). Testing was done in triplicates at three clinical sites (two external sites and one internal site) on three separate days. All MIC values were on-scale and reproducibility demonstrated acceptable performance at 100%. Initial studies using both the VITEK 2 and the VITEK 2 Compact and manual dilution did not meet acceptable reproducibility performance particularly due to C. guillermondii. Per FDA’s request, an additional study was performed using five isolates of C. guillermondii with on-scale Micafungin MIC values. These isolates were tested in triplicate on three separate days at three sites and included a total of 45 data points at each site. The best and worst case reproducibility for VITEK 2 and VITE
Classification: |
idK151923_s0_e2000 | K151923.txt | panel | 83 Microbiology | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K151923 B. Purpose for Submission: To obtain a substantial equivalence determination for the addition of Micafungin to the VITEK® 2 and VITEK® 2 Compact Systems Antimicrobial Susceptibility Test (AST) Systems C. Measurand: The VITEK 2 AST Yeast card contains the following concentration of Micafungin: 0.06, 0.25, 1 and 4μg/mL. The MIC result reporting range for the VITEK 2 card is ≤ 0.06 - ≥8 µg/ml. D. Type of Test: Automated quantitative or qualitative antifungal susceptibility test of Candida species to Micafungin E. Applicant: bioMérieux, Inc. F. Proprietary and Established Names: VITEK® 2 AST-Yeast Micafungin (0.06 - 8 µg/mL) G. Regulatory Information: 1. Regulation section: 21 CFR 866.1640, Antimicrobial Susceptibility Test Powder 2. Classification: II 3. Product code: NGZ – Susceptibility Test Plate, Antifungal 2 LRG – Instrument for Auto Reader and Interpretation of Overnight Susceptibility Systems LTT – Panels, Test, Susceptibility, Antimicrobial LTW – Susceptibility Test Cards, Antimicrobial 4. Panel: 83 Microbiology H. Intended Use: 1. Intended use (s): The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast. 2. Indication(s) for use: VITEK® 2 Yeast Micafungin is designed for antifungal susceptibility testing of Candida species. VITEK® 2 Yeast Micafungin is a quantitative test intended for use with the VITEK® 2 COMPACT Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 Yeast Micafungin has been shown to be active against most isolates of the microorganisms listed below, according to the FDA label for this antifungal. Active in vitro and in clinical infections Candida albicans Candida glabrata Candida guilliermondii Candida krusei Candida parapsilosis Candida tropicalis The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. S. pneumoniae, and clinically significant yeast. 3 3. Special conditions for use statement(s): For prescription use only The following limitations are included in the device labeling: “The ability of the AST card to detect resistance with the following combination(s) is unknown because an insufficient number of resistant strains were available at the time of comparative testing. If such a strain is observed, it should be submitted to a reference laboratory for further testing: Micafungin: Candida glabrata” “The ability of the AST card to detect resistance with the following combination(s) is unknown because resistant strains were not available at the time of comparative testing: Micafungin: Candida spp” 4. Special instrument requirements: For use with the VITEK® 2 and VITEK® 2 Compact Systems I. Device Description: The VITEK® 2 AST card is a miniaturized, abbreviated and automated version of the doubling dilution technique for determining the minimum inhibitory concentration (MIC). Each VITEK® 2 test card contains 64 microwells. A control well containing only culture medium is included on all cards, with the remaining wells containing premeasured amounts of a specific antimicrobial agent in a culture medium base. A suspension of organism from a pure culture is prepared in a tube containing 0.45-0.5% sterile saline and standardized to a McFarland 0.5 using the DensiCHEK Plus™. The VITEK 2 System automatically fills, seals and places the card into the incubator/reader; manual methods can also be used for the inoculation of test cards for use in the VITEK 2 System. The VITEK 2 Compact has a manual filling, sealing and loading operation. The VITEK 2 Systems monitor the growth of each well in the card over a defined period of time. At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antimicrobial contained on the card. The VITEK® 2 AST-Yeast Micafungin has the following concentrations in the card: 0.06, 0.25, 1 and 4 μg/mL (equivalent standard method concentration by efficacy in μg/mL). The MIC result range for the VITEK® 2 card is ≤0.06-≥8 µg/ml. J. Substantial Equivalence Information: 1. Predicate device name(s): VITEK® 2 AST-YST Flucytosine 4 2. Predicate 510(k) number(s): K133952 3. Comparison with predicate: Similarities Item Device VITEK 2 AST-
Yeast Micafungin Predicate VITEK 2 AST-
YS Flucytosine (K133952) Intended Use VITEK2 Yeast Micafungin is designed for antifungal susceptibility testing of Candida species. Vitek 2 Yeast Micafungin is a quantitative test intended for use with the VITEK 2 and VITEK 2 COMPACT Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. Same Test Methodology Automated yeast antifungal susceptibility test for use with the VITEK 2 and VITEK 2 Compact Systems (VITEK 2 Systems) to determine the in vitro susceptibility of Candida species. Same Inoculum Saline suspension of organism Same Test Card VITEK 2 Antifungal Susceptibility Test Card Same Instrument VITEK 2 and VITEK 2 Compact Systems Same Analysis algorithm Discriminate Analysis Same Differences Item Device Predicate Antimicrobial Agent Micafungin Flucytosine Antimicrobial Concentrations 0.06, 0.25, 1, 4 1, 4, 16, 32 K. Standard/Guidance Document Referenced (if applicable): CLSI Document M27-A3, Reference Method for Broth Dilution Antifungal Susceptibility 5 Testing of Yeasts; Approved Standard-Third Edition, Vol. 28 No.14 CLSI Document M27-S4, Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Fourth Informational Supplement, Vol.32 No. 17 L. Test Principle: The VITEK® 2 System optics use visible light to directly measure organism growth. The transmittance optics are based on an initial light reading of a well before significant growth has begun. Periodic light transmittance samplings of the same well measure organism growth by how much light is prevented from going through the well. Several parameters based on the growth characteristics observed are used to provide appropriate input for the MIC calculations. Discriminate analysis is used to develop the algorithm that determines the susceptibility result for all antimicrobials on the VITEK® 2 System. The MIC result must be linked to organism identification in order to determine a category interpretation. A category interpretation (SIR) will be reported along with each MIC result. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Reproducibility studies included both the auto- and manual dilution methods with the VITEK 2 instrument system and the manual dilution method with the VITEK 2 Compact instrument system. With each inoculation method, the mode MIC was determined for each isolate and the reproducibility was calculated based on MIC values falling within ± 1 dilution of the mode MIC. Testing using VITEK 2 and automatic dilution was performed using 10 Candida isolates (four isolates of C. parapsilosis, two C. krusei, two C. norvegensis, and two C. gulliermondii). Testing was done in triplicates at three clinical sites (two external sites and one internal site) on three separate days. All MIC values were on-scale and reproducibility demonstrated acceptable performance at 100%. Initial studies using both the VITEK 2 and the VITEK 2 Compact and manual dilution did not meet acceptable reproducibility performance particularly due to C. guillermondii. Per FDA’s request, an additional study was performed using five isolates of C. guillermondii with on-scale Micafungin MIC values. These isolates were tested in triplicate on three separate days at three sites and included a total of 45 data points at each site. The best and worst case reproducibility for VITEK 2 and VITE
Panel: |
idK151923_s0_e2000 | K151923.txt | intended use | The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast. | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K151923 B. Purpose for Submission: To obtain a substantial equivalence determination for the addition of Micafungin to the VITEK® 2 and VITEK® 2 Compact Systems Antimicrobial Susceptibility Test (AST) Systems C. Measurand: The VITEK 2 AST Yeast card contains the following concentration of Micafungin: 0.06, 0.25, 1 and 4μg/mL. The MIC result reporting range for the VITEK 2 card is ≤ 0.06 - ≥8 µg/ml. D. Type of Test: Automated quantitative or qualitative antifungal susceptibility test of Candida species to Micafungin E. Applicant: bioMérieux, Inc. F. Proprietary and Established Names: VITEK® 2 AST-Yeast Micafungin (0.06 - 8 µg/mL) G. Regulatory Information: 1. Regulation section: 21 CFR 866.1640, Antimicrobial Susceptibility Test Powder 2. Classification: II 3. Product code: NGZ – Susceptibility Test Plate, Antifungal 2 LRG – Instrument for Auto Reader and Interpretation of Overnight Susceptibility Systems LTT – Panels, Test, Susceptibility, Antimicrobial LTW – Susceptibility Test Cards, Antimicrobial 4. Panel: 83 Microbiology H. Intended Use: 1. Intended use (s): The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast. 2. Indication(s) for use: VITEK® 2 Yeast Micafungin is designed for antifungal susceptibility testing of Candida species. VITEK® 2 Yeast Micafungin is a quantitative test intended for use with the VITEK® 2 COMPACT Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 Yeast Micafungin has been shown to be active against most isolates of the microorganisms listed below, according to the FDA label for this antifungal. Active in vitro and in clinical infections Candida albicans Candida glabrata Candida guilliermondii Candida krusei Candida parapsilosis Candida tropicalis The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. S. pneumoniae, and clinically significant yeast. 3 3. Special conditions for use statement(s): For prescription use only The following limitations are included in the device labeling: “The ability of the AST card to detect resistance with the following combination(s) is unknown because an insufficient number of resistant strains were available at the time of comparative testing. If such a strain is observed, it should be submitted to a reference laboratory for further testing: Micafungin: Candida glabrata” “The ability of the AST card to detect resistance with the following combination(s) is unknown because resistant strains were not available at the time of comparative testing: Micafungin: Candida spp” 4. Special instrument requirements: For use with the VITEK® 2 and VITEK® 2 Compact Systems I. Device Description: The VITEK® 2 AST card is a miniaturized, abbreviated and automated version of the doubling dilution technique for determining the minimum inhibitory concentration (MIC). Each VITEK® 2 test card contains 64 microwells. A control well containing only culture medium is included on all cards, with the remaining wells containing premeasured amounts of a specific antimicrobial agent in a culture medium base. A suspension of organism from a pure culture is prepared in a tube containing 0.45-0.5% sterile saline and standardized to a McFarland 0.5 using the DensiCHEK Plus™. The VITEK 2 System automatically fills, seals and places the card into the incubator/reader; manual methods can also be used for the inoculation of test cards for use in the VITEK 2 System. The VITEK 2 Compact has a manual filling, sealing and loading operation. The VITEK 2 Systems monitor the growth of each well in the card over a defined period of time. At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antimicrobial contained on the card. The VITEK® 2 AST-Yeast Micafungin has the following concentrations in the card: 0.06, 0.25, 1 and 4 μg/mL (equivalent standard method concentration by efficacy in μg/mL). The MIC result range for the VITEK® 2 card is ≤0.06-≥8 µg/ml. J. Substantial Equivalence Information: 1. Predicate device name(s): VITEK® 2 AST-YST Flucytosine 4 2. Predicate 510(k) number(s): K133952 3. Comparison with predicate: Similarities Item Device VITEK 2 AST-
Yeast Micafungin Predicate VITEK 2 AST-
YS Flucytosine (K133952) Intended Use VITEK2 Yeast Micafungin is designed for antifungal susceptibility testing of Candida species. Vitek 2 Yeast Micafungin is a quantitative test intended for use with the VITEK 2 and VITEK 2 COMPACT Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. Same Test Methodology Automated yeast antifungal susceptibility test for use with the VITEK 2 and VITEK 2 Compact Systems (VITEK 2 Systems) to determine the in vitro susceptibility of Candida species. Same Inoculum Saline suspension of organism Same Test Card VITEK 2 Antifungal Susceptibility Test Card Same Instrument VITEK 2 and VITEK 2 Compact Systems Same Analysis algorithm Discriminate Analysis Same Differences Item Device Predicate Antimicrobial Agent Micafungin Flucytosine Antimicrobial Concentrations 0.06, 0.25, 1, 4 1, 4, 16, 32 K. Standard/Guidance Document Referenced (if applicable): CLSI Document M27-A3, Reference Method for Broth Dilution Antifungal Susceptibility 5 Testing of Yeasts; Approved Standard-Third Edition, Vol. 28 No.14 CLSI Document M27-S4, Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Fourth Informational Supplement, Vol.32 No. 17 L. Test Principle: The VITEK® 2 System optics use visible light to directly measure organism growth. The transmittance optics are based on an initial light reading of a well before significant growth has begun. Periodic light transmittance samplings of the same well measure organism growth by how much light is prevented from going through the well. Several parameters based on the growth characteristics observed are used to provide appropriate input for the MIC calculations. Discriminate analysis is used to develop the algorithm that determines the susceptibility result for all antimicrobials on the VITEK® 2 System. The MIC result must be linked to organism identification in order to determine a category interpretation. A category interpretation (SIR) will be reported along with each MIC result. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Reproducibility studies included both the auto- and manual dilution methods with the VITEK 2 instrument system and the manual dilution method with the VITEK 2 Compact instrument system. With each inoculation method, the mode MIC was determined for each isolate and the reproducibility was calculated based on MIC values falling within ± 1 dilution of the mode MIC. Testing using VITEK 2 and automatic dilution was performed using 10 Candida isolates (four isolates of C. parapsilosis, two C. krusei, two C. norvegensis, and two C. gulliermondii). Testing was done in triplicates at three clinical sites (two external sites and one internal site) on three separate days. All MIC values were on-scale and reproducibility demonstrated acceptable performance at 100%. Initial studies using both the VITEK 2 and the VITEK 2 Compact and manual dilution did not meet acceptable reproducibility performance particularly due to C. guillermondii. Per FDA’s request, an additional study was performed using five isolates of C. guillermondii with on-scale Micafungin MIC values. These isolates were tested in triplicate on three separate days at three sites and included a total of 45 data points at each site. The best and worst case reproducibility for VITEK 2 and VITE
Intended use: |
idK151923_s0_e2000 | K151923.txt | predicate device name | VITEK® 2 AST-YST Flucytosine | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K151923 B. Purpose for Submission: To obtain a substantial equivalence determination for the addition of Micafungin to the VITEK® 2 and VITEK® 2 Compact Systems Antimicrobial Susceptibility Test (AST) Systems C. Measurand: The VITEK 2 AST Yeast card contains the following concentration of Micafungin: 0.06, 0.25, 1 and 4μg/mL. The MIC result reporting range for the VITEK 2 card is ≤ 0.06 - ≥8 µg/ml. D. Type of Test: Automated quantitative or qualitative antifungal susceptibility test of Candida species to Micafungin E. Applicant: bioMérieux, Inc. F. Proprietary and Established Names: VITEK® 2 AST-Yeast Micafungin (0.06 - 8 µg/mL) G. Regulatory Information: 1. Regulation section: 21 CFR 866.1640, Antimicrobial Susceptibility Test Powder 2. Classification: II 3. Product code: NGZ – Susceptibility Test Plate, Antifungal 2 LRG – Instrument for Auto Reader and Interpretation of Overnight Susceptibility Systems LTT – Panels, Test, Susceptibility, Antimicrobial LTW – Susceptibility Test Cards, Antimicrobial 4. Panel: 83 Microbiology H. Intended Use: 1. Intended use (s): The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast. 2. Indication(s) for use: VITEK® 2 Yeast Micafungin is designed for antifungal susceptibility testing of Candida species. VITEK® 2 Yeast Micafungin is a quantitative test intended for use with the VITEK® 2 COMPACT Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 Yeast Micafungin has been shown to be active against most isolates of the microorganisms listed below, according to the FDA label for this antifungal. Active in vitro and in clinical infections Candida albicans Candida glabrata Candida guilliermondii Candida krusei Candida parapsilosis Candida tropicalis The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. S. pneumoniae, and clinically significant yeast. 3 3. Special conditions for use statement(s): For prescription use only The following limitations are included in the device labeling: “The ability of the AST card to detect resistance with the following combination(s) is unknown because an insufficient number of resistant strains were available at the time of comparative testing. If such a strain is observed, it should be submitted to a reference laboratory for further testing: Micafungin: Candida glabrata” “The ability of the AST card to detect resistance with the following combination(s) is unknown because resistant strains were not available at the time of comparative testing: Micafungin: Candida spp” 4. Special instrument requirements: For use with the VITEK® 2 and VITEK® 2 Compact Systems I. Device Description: The VITEK® 2 AST card is a miniaturized, abbreviated and automated version of the doubling dilution technique for determining the minimum inhibitory concentration (MIC). Each VITEK® 2 test card contains 64 microwells. A control well containing only culture medium is included on all cards, with the remaining wells containing premeasured amounts of a specific antimicrobial agent in a culture medium base. A suspension of organism from a pure culture is prepared in a tube containing 0.45-0.5% sterile saline and standardized to a McFarland 0.5 using the DensiCHEK Plus™. The VITEK 2 System automatically fills, seals and places the card into the incubator/reader; manual methods can also be used for the inoculation of test cards for use in the VITEK 2 System. The VITEK 2 Compact has a manual filling, sealing and loading operation. The VITEK 2 Systems monitor the growth of each well in the card over a defined period of time. At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antimicrobial contained on the card. The VITEK® 2 AST-Yeast Micafungin has the following concentrations in the card: 0.06, 0.25, 1 and 4 μg/mL (equivalent standard method concentration by efficacy in μg/mL). The MIC result range for the VITEK® 2 card is ≤0.06-≥8 µg/ml. J. Substantial Equivalence Information: 1. Predicate device name(s): VITEK® 2 AST-YST Flucytosine 4 2. Predicate 510(k) number(s): K133952 3. Comparison with predicate: Similarities Item Device VITEK 2 AST-
Yeast Micafungin Predicate VITEK 2 AST-
YS Flucytosine (K133952) Intended Use VITEK2 Yeast Micafungin is designed for antifungal susceptibility testing of Candida species. Vitek 2 Yeast Micafungin is a quantitative test intended for use with the VITEK 2 and VITEK 2 COMPACT Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. Same Test Methodology Automated yeast antifungal susceptibility test for use with the VITEK 2 and VITEK 2 Compact Systems (VITEK 2 Systems) to determine the in vitro susceptibility of Candida species. Same Inoculum Saline suspension of organism Same Test Card VITEK 2 Antifungal Susceptibility Test Card Same Instrument VITEK 2 and VITEK 2 Compact Systems Same Analysis algorithm Discriminate Analysis Same Differences Item Device Predicate Antimicrobial Agent Micafungin Flucytosine Antimicrobial Concentrations 0.06, 0.25, 1, 4 1, 4, 16, 32 K. Standard/Guidance Document Referenced (if applicable): CLSI Document M27-A3, Reference Method for Broth Dilution Antifungal Susceptibility 5 Testing of Yeasts; Approved Standard-Third Edition, Vol. 28 No.14 CLSI Document M27-S4, Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Fourth Informational Supplement, Vol.32 No. 17 L. Test Principle: The VITEK® 2 System optics use visible light to directly measure organism growth. The transmittance optics are based on an initial light reading of a well before significant growth has begun. Periodic light transmittance samplings of the same well measure organism growth by how much light is prevented from going through the well. Several parameters based on the growth characteristics observed are used to provide appropriate input for the MIC calculations. Discriminate analysis is used to develop the algorithm that determines the susceptibility result for all antimicrobials on the VITEK® 2 System. The MIC result must be linked to organism identification in order to determine a category interpretation. A category interpretation (SIR) will be reported along with each MIC result. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Reproducibility studies included both the auto- and manual dilution methods with the VITEK 2 instrument system and the manual dilution method with the VITEK 2 Compact instrument system. With each inoculation method, the mode MIC was determined for each isolate and the reproducibility was calculated based on MIC values falling within ± 1 dilution of the mode MIC. Testing using VITEK 2 and automatic dilution was performed using 10 Candida isolates (four isolates of C. parapsilosis, two C. krusei, two C. norvegensis, and two C. gulliermondii). Testing was done in triplicates at three clinical sites (two external sites and one internal site) on three separate days. All MIC values were on-scale and reproducibility demonstrated acceptable performance at 100%. Initial studies using both the VITEK 2 and the VITEK 2 Compact and manual dilution did not meet acceptable reproducibility performance particularly due to C. guillermondii. Per FDA’s request, an additional study was performed using five isolates of C. guillermondii with on-scale Micafungin MIC values. These isolates were tested in triplicate on three separate days at three sites and included a total of 45 data points at each site. The best and worst case reproducibility for VITEK 2 and VITE
Predicate device name: |
idK151923_s0_e2000 | K151923.txt | applicant | bioMérieux, Inc. | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K151923 B. Purpose for Submission: To obtain a substantial equivalence determination for the addition of Micafungin to the VITEK® 2 and VITEK® 2 Compact Systems Antimicrobial Susceptibility Test (AST) Systems C. Measurand: The VITEK 2 AST Yeast card contains the following concentration of Micafungin: 0.06, 0.25, 1 and 4μg/mL. The MIC result reporting range for the VITEK 2 card is ≤ 0.06 - ≥8 µg/ml. D. Type of Test: Automated quantitative or qualitative antifungal susceptibility test of Candida species to Micafungin E. Applicant: bioMérieux, Inc. F. Proprietary and Established Names: VITEK® 2 AST-Yeast Micafungin (0.06 - 8 µg/mL) G. Regulatory Information: 1. Regulation section: 21 CFR 866.1640, Antimicrobial Susceptibility Test Powder 2. Classification: II 3. Product code: NGZ – Susceptibility Test Plate, Antifungal 2 LRG – Instrument for Auto Reader and Interpretation of Overnight Susceptibility Systems LTT – Panels, Test, Susceptibility, Antimicrobial LTW – Susceptibility Test Cards, Antimicrobial 4. Panel: 83 Microbiology H. Intended Use: 1. Intended use (s): The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast. 2. Indication(s) for use: VITEK® 2 Yeast Micafungin is designed for antifungal susceptibility testing of Candida species. VITEK® 2 Yeast Micafungin is a quantitative test intended for use with the VITEK® 2 COMPACT Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 Yeast Micafungin has been shown to be active against most isolates of the microorganisms listed below, according to the FDA label for this antifungal. Active in vitro and in clinical infections Candida albicans Candida glabrata Candida guilliermondii Candida krusei Candida parapsilosis Candida tropicalis The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. S. pneumoniae, and clinically significant yeast. 3 3. Special conditions for use statement(s): For prescription use only The following limitations are included in the device labeling: “The ability of the AST card to detect resistance with the following combination(s) is unknown because an insufficient number of resistant strains were available at the time of comparative testing. If such a strain is observed, it should be submitted to a reference laboratory for further testing: Micafungin: Candida glabrata” “The ability of the AST card to detect resistance with the following combination(s) is unknown because resistant strains were not available at the time of comparative testing: Micafungin: Candida spp” 4. Special instrument requirements: For use with the VITEK® 2 and VITEK® 2 Compact Systems I. Device Description: The VITEK® 2 AST card is a miniaturized, abbreviated and automated version of the doubling dilution technique for determining the minimum inhibitory concentration (MIC). Each VITEK® 2 test card contains 64 microwells. A control well containing only culture medium is included on all cards, with the remaining wells containing premeasured amounts of a specific antimicrobial agent in a culture medium base. A suspension of organism from a pure culture is prepared in a tube containing 0.45-0.5% sterile saline and standardized to a McFarland 0.5 using the DensiCHEK Plus™. The VITEK 2 System automatically fills, seals and places the card into the incubator/reader; manual methods can also be used for the inoculation of test cards for use in the VITEK 2 System. The VITEK 2 Compact has a manual filling, sealing and loading operation. The VITEK 2 Systems monitor the growth of each well in the card over a defined period of time. At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antimicrobial contained on the card. The VITEK® 2 AST-Yeast Micafungin has the following concentrations in the card: 0.06, 0.25, 1 and 4 μg/mL (equivalent standard method concentration by efficacy in μg/mL). The MIC result range for the VITEK® 2 card is ≤0.06-≥8 µg/ml. J. Substantial Equivalence Information: 1. Predicate device name(s): VITEK® 2 AST-YST Flucytosine 4 2. Predicate 510(k) number(s): K133952 3. Comparison with predicate: Similarities Item Device VITEK 2 AST-
Yeast Micafungin Predicate VITEK 2 AST-
YS Flucytosine (K133952) Intended Use VITEK2 Yeast Micafungin is designed for antifungal susceptibility testing of Candida species. Vitek 2 Yeast Micafungin is a quantitative test intended for use with the VITEK 2 and VITEK 2 COMPACT Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. Same Test Methodology Automated yeast antifungal susceptibility test for use with the VITEK 2 and VITEK 2 Compact Systems (VITEK 2 Systems) to determine the in vitro susceptibility of Candida species. Same Inoculum Saline suspension of organism Same Test Card VITEK 2 Antifungal Susceptibility Test Card Same Instrument VITEK 2 and VITEK 2 Compact Systems Same Analysis algorithm Discriminate Analysis Same Differences Item Device Predicate Antimicrobial Agent Micafungin Flucytosine Antimicrobial Concentrations 0.06, 0.25, 1, 4 1, 4, 16, 32 K. Standard/Guidance Document Referenced (if applicable): CLSI Document M27-A3, Reference Method for Broth Dilution Antifungal Susceptibility 5 Testing of Yeasts; Approved Standard-Third Edition, Vol. 28 No.14 CLSI Document M27-S4, Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Fourth Informational Supplement, Vol.32 No. 17 L. Test Principle: The VITEK® 2 System optics use visible light to directly measure organism growth. The transmittance optics are based on an initial light reading of a well before significant growth has begun. Periodic light transmittance samplings of the same well measure organism growth by how much light is prevented from going through the well. Several parameters based on the growth characteristics observed are used to provide appropriate input for the MIC calculations. Discriminate analysis is used to develop the algorithm that determines the susceptibility result for all antimicrobials on the VITEK® 2 System. The MIC result must be linked to organism identification in order to determine a category interpretation. A category interpretation (SIR) will be reported along with each MIC result. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Reproducibility studies included both the auto- and manual dilution methods with the VITEK 2 instrument system and the manual dilution method with the VITEK 2 Compact instrument system. With each inoculation method, the mode MIC was determined for each isolate and the reproducibility was calculated based on MIC values falling within ± 1 dilution of the mode MIC. Testing using VITEK 2 and automatic dilution was performed using 10 Candida isolates (four isolates of C. parapsilosis, two C. krusei, two C. norvegensis, and two C. gulliermondii). Testing was done in triplicates at three clinical sites (two external sites and one internal site) on three separate days. All MIC values were on-scale and reproducibility demonstrated acceptable performance at 100%. Initial studies using both the VITEK 2 and the VITEK 2 Compact and manual dilution did not meet acceptable reproducibility performance particularly due to C. guillermondii. Per FDA’s request, an additional study was performed using five isolates of C. guillermondii with on-scale Micafungin MIC values. These isolates were tested in triplicate on three separate days at three sites and included a total of 45 data points at each site. The best and worst case reproducibility for VITEK 2 and VITE
Applicant: |
idK151923_s0_e2000 | K151923.txt | proprietary and established names | VITEK® 2 AST-Yeast Micafungin (0.06 - 8 µg/mL) | IAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K151923 B. Purpose for Submission: To obtain a substantial equivalence determination for the addition of Micafungin to the VITEK® 2 and VITEK® 2 Compact Systems Antimicrobial Susceptibility Test (AST) Systems C. Measurand: The VITEK 2 AST Yeast card contains the following concentration of Micafungin: 0.06, 0.25, 1 and 4μg/mL. The MIC result reporting range for the VITEK 2 card is ≤ 0.06 - ≥8 µg/ml. D. Type of Test: Automated quantitative or qualitative antifungal susceptibility test of Candida species to Micafungin E. Applicant: bioMérieux, Inc. F. Proprietary and Established Names: VITEK® 2 AST-Yeast Micafungin (0.06 - 8 µg/mL) G. Regulatory Information: 1. Regulation section: 21 CFR 866.1640, Antimicrobial Susceptibility Test Powder 2. Classification: II 3. Product code: NGZ – Susceptibility Test Plate, Antifungal 2 LRG – Instrument for Auto Reader and Interpretation of Overnight Susceptibility Systems LTT – Panels, Test, Susceptibility, Antimicrobial LTW – Susceptibility Test Cards, Antimicrobial 4. Panel: 83 Microbiology H. Intended Use: 1. Intended use (s): The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast. 2. Indication(s) for use: VITEK® 2 Yeast Micafungin is designed for antifungal susceptibility testing of Candida species. VITEK® 2 Yeast Micafungin is a quantitative test intended for use with the VITEK® 2 COMPACT Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 Yeast Micafungin has been shown to be active against most isolates of the microorganisms listed below, according to the FDA label for this antifungal. Active in vitro and in clinical infections Candida albicans Candida glabrata Candida guilliermondii Candida krusei Candida parapsilosis Candida tropicalis The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. S. pneumoniae, and clinically significant yeast. 3 3. Special conditions for use statement(s): For prescription use only The following limitations are included in the device labeling: “The ability of the AST card to detect resistance with the following combination(s) is unknown because an insufficient number of resistant strains were available at the time of comparative testing. If such a strain is observed, it should be submitted to a reference laboratory for further testing: Micafungin: Candida glabrata” “The ability of the AST card to detect resistance with the following combination(s) is unknown because resistant strains were not available at the time of comparative testing: Micafungin: Candida spp” 4. Special instrument requirements: For use with the VITEK® 2 and VITEK® 2 Compact Systems I. Device Description: The VITEK® 2 AST card is a miniaturized, abbreviated and automated version of the doubling dilution technique for determining the minimum inhibitory concentration (MIC). Each VITEK® 2 test card contains 64 microwells. A control well containing only culture medium is included on all cards, with the remaining wells containing premeasured amounts of a specific antimicrobial agent in a culture medium base. A suspension of organism from a pure culture is prepared in a tube containing 0.45-0.5% sterile saline and standardized to a McFarland 0.5 using the DensiCHEK Plus™. The VITEK 2 System automatically fills, seals and places the card into the incubator/reader; manual methods can also be used for the inoculation of test cards for use in the VITEK 2 System. The VITEK 2 Compact has a manual filling, sealing and loading operation. The VITEK 2 Systems monitor the growth of each well in the card over a defined period of time. At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antimicrobial contained on the card. The VITEK® 2 AST-Yeast Micafungin has the following concentrations in the card: 0.06, 0.25, 1 and 4 μg/mL (equivalent standard method concentration by efficacy in μg/mL). The MIC result range for the VITEK® 2 card is ≤0.06-≥8 µg/ml. J. Substantial Equivalence Information: 1. Predicate device name(s): VITEK® 2 AST-YST Flucytosine 4 2. Predicate 510(k) number(s): K133952 3. Comparison with predicate: Similarities Item Device VITEK 2 AST-
Yeast Micafungin Predicate VITEK 2 AST-
YS Flucytosine (K133952) Intended Use VITEK2 Yeast Micafungin is designed for antifungal susceptibility testing of Candida species. Vitek 2 Yeast Micafungin is a quantitative test intended for use with the VITEK 2 and VITEK 2 COMPACT Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. Same Test Methodology Automated yeast antifungal susceptibility test for use with the VITEK 2 and VITEK 2 Compact Systems (VITEK 2 Systems) to determine the in vitro susceptibility of Candida species. Same Inoculum Saline suspension of organism Same Test Card VITEK 2 Antifungal Susceptibility Test Card Same Instrument VITEK 2 and VITEK 2 Compact Systems Same Analysis algorithm Discriminate Analysis Same Differences Item Device Predicate Antimicrobial Agent Micafungin Flucytosine Antimicrobial Concentrations 0.06, 0.25, 1, 4 1, 4, 16, 32 K. Standard/Guidance Document Referenced (if applicable): CLSI Document M27-A3, Reference Method for Broth Dilution Antifungal Susceptibility 5 Testing of Yeasts; Approved Standard-Third Edition, Vol. 28 No.14 CLSI Document M27-S4, Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Fourth Informational Supplement, Vol.32 No. 17 L. Test Principle: The VITEK® 2 System optics use visible light to directly measure organism growth. The transmittance optics are based on an initial light reading of a well before significant growth has begun. Periodic light transmittance samplings of the same well measure organism growth by how much light is prevented from going through the well. Several parameters based on the growth characteristics observed are used to provide appropriate input for the MIC calculations. Discriminate analysis is used to develop the algorithm that determines the susceptibility result for all antimicrobials on the VITEK® 2 System. The MIC result must be linked to organism identification in order to determine a category interpretation. A category interpretation (SIR) will be reported along with each MIC result. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Reproducibility studies included both the auto- and manual dilution methods with the VITEK 2 instrument system and the manual dilution method with the VITEK 2 Compact instrument system. With each inoculation method, the mode MIC was determined for each isolate and the reproducibility was calculated based on MIC values falling within ± 1 dilution of the mode MIC. Testing using VITEK 2 and automatic dilution was performed using 10 Candida isolates (four isolates of C. parapsilosis, two C. krusei, two C. norvegensis, and two C. gulliermondii). Testing was done in triplicates at three clinical sites (two external sites and one internal site) on three separate days. All MIC values were on-scale and reproducibility demonstrated acceptable performance at 100%. Initial studies using both the VITEK 2 and the VITEK 2 Compact and manual dilution did not meet acceptable reproducibility performance particularly due to C. guillermondii. Per FDA’s request, an additional study was performed using five isolates of C. guillermondii with on-scale Micafungin MIC values. These isolates were tested in triplicate on three separate days at three sites and included a total of 45 data points at each site. The best and worst case reproducibility for VITEK 2 and VITE
Proprietary and established names: |
idK151923_s0_e2000 | K151923.txt | regulation section | 21 CFR 866.1640, Antimicrobial Susceptibility Test Powder | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K151923 B. Purpose for Submission: To obtain a substantial equivalence determination for the addition of Micafungin to the VITEK® 2 and VITEK® 2 Compact Systems Antimicrobial Susceptibility Test (AST) Systems C. Measurand: The VITEK 2 AST Yeast card contains the following concentration of Micafungin: 0.06, 0.25, 1 and 4μg/mL. The MIC result reporting range for the VITEK 2 card is ≤ 0.06 - ≥8 µg/ml. D. Type of Test: Automated quantitative or qualitative antifungal susceptibility test of Candida species to Micafungin E. Applicant: bioMérieux, Inc. F. Proprietary and Established Names: VITEK® 2 AST-Yeast Micafungin (0.06 - 8 µg/mL) G. Regulatory Information: 1. Regulation section: 21 CFR 866.1640, Antimicrobial Susceptibility Test Powder 2. Classification: II 3. Product code: NGZ – Susceptibility Test Plate, Antifungal 2 LRG – Instrument for Auto Reader and Interpretation of Overnight Susceptibility Systems LTT – Panels, Test, Susceptibility, Antimicrobial LTW – Susceptibility Test Cards, Antimicrobial 4. Panel: 83 Microbiology H. Intended Use: 1. Intended use (s): The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast. 2. Indication(s) for use: VITEK® 2 Yeast Micafungin is designed for antifungal susceptibility testing of Candida species. VITEK® 2 Yeast Micafungin is a quantitative test intended for use with the VITEK® 2 COMPACT Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 Yeast Micafungin has been shown to be active against most isolates of the microorganisms listed below, according to the FDA label for this antifungal. Active in vitro and in clinical infections Candida albicans Candida glabrata Candida guilliermondii Candida krusei Candida parapsilosis Candida tropicalis The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. S. pneumoniae, and clinically significant yeast. 3 3. Special conditions for use statement(s): For prescription use only The following limitations are included in the device labeling: “The ability of the AST card to detect resistance with the following combination(s) is unknown because an insufficient number of resistant strains were available at the time of comparative testing. If such a strain is observed, it should be submitted to a reference laboratory for further testing: Micafungin: Candida glabrata” “The ability of the AST card to detect resistance with the following combination(s) is unknown because resistant strains were not available at the time of comparative testing: Micafungin: Candida spp” 4. Special instrument requirements: For use with the VITEK® 2 and VITEK® 2 Compact Systems I. Device Description: The VITEK® 2 AST card is a miniaturized, abbreviated and automated version of the doubling dilution technique for determining the minimum inhibitory concentration (MIC). Each VITEK® 2 test card contains 64 microwells. A control well containing only culture medium is included on all cards, with the remaining wells containing premeasured amounts of a specific antimicrobial agent in a culture medium base. A suspension of organism from a pure culture is prepared in a tube containing 0.45-0.5% sterile saline and standardized to a McFarland 0.5 using the DensiCHEK Plus™. The VITEK 2 System automatically fills, seals and places the card into the incubator/reader; manual methods can also be used for the inoculation of test cards for use in the VITEK 2 System. The VITEK 2 Compact has a manual filling, sealing and loading operation. The VITEK 2 Systems monitor the growth of each well in the card over a defined period of time. At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antimicrobial contained on the card. The VITEK® 2 AST-Yeast Micafungin has the following concentrations in the card: 0.06, 0.25, 1 and 4 μg/mL (equivalent standard method concentration by efficacy in μg/mL). The MIC result range for the VITEK® 2 card is ≤0.06-≥8 µg/ml. J. Substantial Equivalence Information: 1. Predicate device name(s): VITEK® 2 AST-YST Flucytosine 4 2. Predicate 510(k) number(s): K133952 3. Comparison with predicate: Similarities Item Device VITEK 2 AST-
Yeast Micafungin Predicate VITEK 2 AST-
YS Flucytosine (K133952) Intended Use VITEK2 Yeast Micafungin is designed for antifungal susceptibility testing of Candida species. Vitek 2 Yeast Micafungin is a quantitative test intended for use with the VITEK 2 and VITEK 2 COMPACT Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. Same Test Methodology Automated yeast antifungal susceptibility test for use with the VITEK 2 and VITEK 2 Compact Systems (VITEK 2 Systems) to determine the in vitro susceptibility of Candida species. Same Inoculum Saline suspension of organism Same Test Card VITEK 2 Antifungal Susceptibility Test Card Same Instrument VITEK 2 and VITEK 2 Compact Systems Same Analysis algorithm Discriminate Analysis Same Differences Item Device Predicate Antimicrobial Agent Micafungin Flucytosine Antimicrobial Concentrations 0.06, 0.25, 1, 4 1, 4, 16, 32 K. Standard/Guidance Document Referenced (if applicable): CLSI Document M27-A3, Reference Method for Broth Dilution Antifungal Susceptibility 5 Testing of Yeasts; Approved Standard-Third Edition, Vol. 28 No.14 CLSI Document M27-S4, Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Fourth Informational Supplement, Vol.32 No. 17 L. Test Principle: The VITEK® 2 System optics use visible light to directly measure organism growth. The transmittance optics are based on an initial light reading of a well before significant growth has begun. Periodic light transmittance samplings of the same well measure organism growth by how much light is prevented from going through the well. Several parameters based on the growth characteristics observed are used to provide appropriate input for the MIC calculations. Discriminate analysis is used to develop the algorithm that determines the susceptibility result for all antimicrobials on the VITEK® 2 System. The MIC result must be linked to organism identification in order to determine a category interpretation. A category interpretation (SIR) will be reported along with each MIC result. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: Reproducibility studies included both the auto- and manual dilution methods with the VITEK 2 instrument system and the manual dilution method with the VITEK 2 Compact instrument system. With each inoculation method, the mode MIC was determined for each isolate and the reproducibility was calculated based on MIC values falling within ± 1 dilution of the mode MIC. Testing using VITEK 2 and automatic dilution was performed using 10 Candida isolates (four isolates of C. parapsilosis, two C. krusei, two C. norvegensis, and two C. gulliermondii). Testing was done in triplicates at three clinical sites (two external sites and one internal site) on three separate days. All MIC values were on-scale and reproducibility demonstrated acceptable performance at 100%. Initial studies using both the VITEK 2 and the VITEK 2 Compact and manual dilution did not meet acceptable reproducibility performance particularly due to C. guillermondii. Per FDA’s request, an additional study was performed using five isolates of C. guillermondii with on-scale Micafungin MIC values. These isolates were tested in triplicate on three separate days at three sites and included a total of 45 data points at each site. The best and worst case reproducibility for VITEK 2 and VITE
Regulation section: |
idK151923_s4000_e6000 | K151923.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. | in Combined Clinical and Challenge Study with C. krusei and C. parapsilosis Organism Difference in MIC as Compared to the CLSI Reference Method ≤-3 -2 -1 0 +1 +2 ≥+3 Total C. krusei 0% (0/30) 0% (0/30) 36.6% (11/30) 46.6% (14/30) 13.3% (4/30) 3.3% (1/30) 0% (0/30) 30 C. parapsilosis 3.6% (3/82) 2.4% (2/82) 39.0% (32/82) 43.9% (36/82) 8.5% (7/82) 1.2%(1/82) 1.2% (1/82) 82 Total 2.6% (3/112) 1.7% (2/112) 38.4% (43/112) 44.6% (50/112) 9.8% (11/112) 1.7% (2/112) 0.9% (1/112) 112 This trending and the potential for occurrence of very major error(s) for Micafungin when testing C. krusei and C. parapsilosis was addressed by adding the following footnote in the labeling: “VITEK®2 Micafungin MIC values for C. krusei and C. parapsilosis organisms tended to be one doubling dilution lower compared to reference broth microdilution”. Growth Rate: All isolates tested during the clinical study grew using both the manual and the automatic dilution methods b. Matrix comparison: Not applicable 3. Clinical studies: a. Clinical Sensitivity: Not applicable b. Clinical specificity: Not applicable c. Other clinical supportive data (when a. and b. are not applicable): Not applicable 4. Clinical cut-off: Not applicable 11 5. Expected values/Reference range: Table 8. FDA Interpretive Criteria for Micafungin (µg/mL) Organisms S I R C. albicans C. tropicalis C. krusei ≤0.25 0.5 ≥1 C. parapsilosis C. guillermondii ≤2 4 ≥8 C. glabrata ≤0.06 0.12 ≥0.25 N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
Proposed labeling: |
idK151923_s4000_e6000 | K151923.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | of Results in Combined Clinical and Challenge Study with C. krusei and C. parapsilosis Organism Difference in MIC as Compared to the CLSI Reference Method ≤-3 -2 -1 0 +1 +2 ≥+3 Total C. krusei 0% (0/30) 0% (0/30) 36.6% (11/30) 46.6% (14/30) 13.3% (4/30) 3.3% (1/30) 0% (0/30) 30 C. parapsilosis 3.6% (3/82) 2.4% (2/82) 39.0% (32/82) 43.9% (36/82) 8.5% (7/82) 1.2%(1/82) 1.2% (1/82) 82 Total 2.6% (3/112) 1.7% (2/112) 38.4% (43/112) 44.6% (50/112) 9.8% (11/112) 1.7% (2/112) 0.9% (1/112) 112 This trending and the potential for occurrence of very major error(s) for Micafungin when testing C. krusei and C. parapsilosis was addressed by adding the following footnote in the labeling: “VITEK®2 Micafungin MIC values for C. krusei and C. parapsilosis organisms tended to be one doubling dilution lower compared to reference broth microdilution”. Growth Rate: All isolates tested during the clinical study grew using both the manual and the automatic dilution methods b. Matrix comparison: Not applicable 3. Clinical studies: a. Clinical Sensitivity: Not applicable b. Clinical specificity: Not applicable c. Other clinical supportive data (when a. and b. are not applicable): Not applicable 4. Clinical cut-off: Not applicable 11 5. Expected values/Reference range: Table 8. FDA Interpretive Criteria for Micafungin (µg/mL) Organisms S I R C. albicans C. tropicalis C. krusei ≤0.25 0.5 ≥1 C. parapsilosis C. guillermondii ≤2 4 ≥8 C. glabrata ≤0.06 0.12 ≥0.25 N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
Conclusion: |
idK171742_s0_e2000 | K171742.txt | purpose for submission | New device on two previously cleared instruments | STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K171742 B. Purpose for Submission: New device on two previously cleared instruments C. Measurand: Kappa (κ) Free Light Chain (FLC) Lambda (λ) Free Light Chain (FLC) D. Type of Test: Nephelometry, quantitative E. Applicant: Siemens Healthcare Diagnostics Products GmbH F. Proprietary and Established Names: N Latex FLC Kappa assay N Latex FLC Lambda assay N FLC Standard SL N FLC Control SL1 & SL2 G. Regulatory Information: 1. Regulation section: 21 CFR § 866.5550 – Immunoglobulin (light chain specific) immunological test system 21 CFR § 862.1660 – Quality Control Material (assayed and unassayed) 2. Classification: Class II, test systems 2 3. Product code: DFH, Kappa, antigen, antiserum, control DEH, Lambda, antigen, antiserum, control 4. Panel: Immunology (82) H. Intended Use: 1. Intended uses: N Latex FLC Kappa and N Latex FLC Lambda assays In-vitro diagnostic reagents for the quantitative determination of free light chains (FLC), type kappa or type lambda in human serum and EDTA-plasma by means of particle- enhanced immunonephelometry using the BN Systems. FLC measurements are used as an aid in the diagnosis of multiple myeloma (MM) and amyloidosis (AL). N FLC Supplementary Reagent Supplementary reagent for the immunonephelometric determination of free light chains (FLC), type kappa and type lambda on BN Systems. A mixture of both supplementary reagents is used to suppress interference by rheumatoid factors and human anti-mouse antibodies (HAMA). N FLC Standard SL Establishment of reference curves for the determination of free light chains (FLC), type kappa and type lambda on the BN Systems. N FLC Control SL1 and SL2 The N FLC Controls SL1 and SL2 are for use as assayed accuracy controls and precision controls in the determination of free light chains (FLC), type kappa and type lambda by immunonephelometry with the BN Systems. 2. Indications for use: Same as Intended Uses 3. Special conditions for use statements: For prescription use only 3 Warning: The result of the FLC Kappa or FLC Lambda in a given specimen determined with assays and or instrument plarforms from different manufacturers can vary due to differences in assay methods and reagent specificity. The results reported by the laboratory to the physician must include the identity of the FLC Kappa or FLC Lambda assay used. Values obtained with different assay methods cannot be used interchangeably. 4. Special instrument requirements: BN II (K943997) and BN ProSpec® Systems (K001647) I. Device Description: The N Latex FLC Kappa and N Latex FLC Lambda assays are comprised of the following reagents in liquid form: N latex FLC reagents: Consist of suspension of polysterene particles coated with monoclonal antibodies (mouse) to either human FLC Kappa or human FLC Lambda; conjugate of S-adenosyl-cysteine/porcine thyreoglobin (<0.1 g/L); conjugate of S-adenosyl-
L-homocysteine hydrolase (<100 U/mL); dithiothreitol (<0.5 g/L). Preservative: Sodium azide (<1 g/L) N FLC Supplementary Reagents A and B: N FLC Supplementary Reagent A contains mouse immunoglobulin in buffered solution and N FLC Supplementary Reagent B: consist of a buffered salt solution containing detergent. Preservatives in both Supplemntary reagents: Sodium azide (<1 g/L). N FLC Standard SL: Contains human free light chains proteins, human serum albumin and protease inhibitors. N FLC Controls SL1 and SL2: contains human free light chain proteins, human serum albumin and protease inhibitors. J. Substantial Equivalence Information: 1. Predicate device names and 510(k) numbers: The Binding Site Freelite® Human Kappa Free Kit for use on the Siemens BN™ II - K031016 The Binding Site Freelite® Human Lambda Free Kit for use on the Siemens BN™ II - K031016 4 2. Comparison with predicate: Kappa and Lambda Reagents: Similarities Item Device N Latex FLC Kappa N Latex FLC Lambda Predicate Freelite® Human Kappa Free and Freelite® Human Lambda Free kits on the Siemens BN™II Analyte Kappa: Kappa FLC Lambda: Lambda FLC Same Measurement Quantitative Same Detection Method Nephelometric Same Differences Item Device Predicate Indication for use In-vitro diagnostic reagents for the quantitative determination of free light chains (FLC), type kappa or type lambda, in human serum and EDTA plasma by means of particle- enhanced immunonephelometry using the BN Systems. FLC measurements are used as an aid in the diagnosis of multiple myeloma (MM) and amyloidosis (AL). This kit is intended for the quantitation of kappa free light chains or lambda free light chains in serum and urine on the Siemens BN™ II. Measurement of free light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom’s macroglobulinemia, AL amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus in conjunction with other laboratory and clinical findings. Sample type Serum and EDTA plasma Serum and urine Detection Antibody Kappa: Monoclonal mouse anti-human FLC kappa antibody onto polysterene particles Lambda: Monoclonal mouse anti-human FLC lambda antibody onto polysterene particles Kappa: Polyclonal sheep anti-human kappa antibody coated onto latex particles Lambda: Polyclonal sheep anti-human lambda antibody coated onto latex particles 5 Differences Item Device Predicate Analytical Measuring ranges (Calibrator lot dependent): Kappa: 3.4 – 110 mg/L Lambda: 1.9 – 60 mg/L Kappa: 5.9 – 190 mg/L Lambda: 5.0 – 160 mg/L Instrument System Siemens BN II and BN ProSpec Systems Siemens BN II Reference Interval Kappa: 8.24 – 28.90 mg/L Lambda: 9.10 – 32.60 mg/L Ratio: 0.53 – 1.51 Kappa: 3.30 to 19.40 mg/L Lambda: 5.71 to 26.30 mg/L Ratio: 0.26 – 1.65 Calibrators: Similarities Item Device N Latex FLC Standard SL for the BN Systems Predicate Human Kappa Free Standard and Human Lambda Free Standard on the Siemens BN™II Number of Levels One Same Reference material Internal reference preparation Same Differences Item Device N Latex FLC Standard SL for the BN Systems Predicate Human Kappa Free Standard and Human Lambda Free Standard on the Siemens BN™II Indication for use Establishment of reference curves for the determination of free light chains (FLC), type kappa and type lambda on the BN Systems. Used for the establishment of reference curves for the determination of Freelite® Kappa and Lambda light chains on the BN II System. Matrix Consists of a stabilized liquid containing human free light chain proteins, human serum albumin and protease inhibitors. Contains Consists of human sera that contain kappa free light chain and lambda free light chain respectively. They are 6 Differences Item Device N Latex FLC Standard SL for the BN Systems Predicate Human Kappa Free Standard and Human Lambda Free Standard on the Siemens BN™II sodium azide (<1 g/L) as a preservative. supplied in a stabilized liquid form and contain 0.099% sodium azide, 0.1% E- amino-n-caproic acid (EACA) and 0.01% benzamidine as preservatives. Volume 3 x 1.0 mL 2 x 1.0 mL Analytical values (Control lot dependent) Kappa: 22 mg/L Lambda: 32 mg/L Kappa: 19.99 mg/L Lambda: 16.21 mg/L Controls: Differences Item Device N FLC Control SL 1 N FLC Control SL 2 Predicate Human Kappa Free Control, Human Kappa Free High Control, Human Lambda Free Control and Human Lambda Free High Control Indications for Use The N FLC Controls SL1 and SL2 are for use as assayed accuracy controls and precision controls in the determination of free light chains (FLC), type kappa and type lambda by immunonephelometry with the BN Systems. Used as quality controls for the Freelite® Kappa and Lambda assays on the Siemens BN II Matrix Controls are stabilized liquids containing human free light chain proteins, human serum albumin and protease inhibitors. The concentration of the free light chains (FLC), type kappa and type lambda is Controls consist of human sera
Purpose for submission: |
idK171742_s0_e2000 | K171742.txt | type of test | Nephelometry, quantitative | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K171742 B. Purpose for Submission: New device on two previously cleared instruments C. Measurand: Kappa (κ) Free Light Chain (FLC) Lambda (λ) Free Light Chain (FLC) D. Type of Test: Nephelometry, quantitative E. Applicant: Siemens Healthcare Diagnostics Products GmbH F. Proprietary and Established Names: N Latex FLC Kappa assay N Latex FLC Lambda assay N FLC Standard SL N FLC Control SL1 & SL2 G. Regulatory Information: 1. Regulation section: 21 CFR § 866.5550 – Immunoglobulin (light chain specific) immunological test system 21 CFR § 862.1660 – Quality Control Material (assayed and unassayed) 2. Classification: Class II, test systems 2 3. Product code: DFH, Kappa, antigen, antiserum, control DEH, Lambda, antigen, antiserum, control 4. Panel: Immunology (82) H. Intended Use: 1. Intended uses: N Latex FLC Kappa and N Latex FLC Lambda assays In-vitro diagnostic reagents for the quantitative determination of free light chains (FLC), type kappa or type lambda in human serum and EDTA-plasma by means of particle- enhanced immunonephelometry using the BN Systems. FLC measurements are used as an aid in the diagnosis of multiple myeloma (MM) and amyloidosis (AL). N FLC Supplementary Reagent Supplementary reagent for the immunonephelometric determination of free light chains (FLC), type kappa and type lambda on BN Systems. A mixture of both supplementary reagents is used to suppress interference by rheumatoid factors and human anti-mouse antibodies (HAMA). N FLC Standard SL Establishment of reference curves for the determination of free light chains (FLC), type kappa and type lambda on the BN Systems. N FLC Control SL1 and SL2 The N FLC Controls SL1 and SL2 are for use as assayed accuracy controls and precision controls in the determination of free light chains (FLC), type kappa and type lambda by immunonephelometry with the BN Systems. 2. Indications for use: Same as Intended Uses 3. Special conditions for use statements: For prescription use only 3 Warning: The result of the FLC Kappa or FLC Lambda in a given specimen determined with assays and or instrument plarforms from different manufacturers can vary due to differences in assay methods and reagent specificity. The results reported by the laboratory to the physician must include the identity of the FLC Kappa or FLC Lambda assay used. Values obtained with different assay methods cannot be used interchangeably. 4. Special instrument requirements: BN II (K943997) and BN ProSpec® Systems (K001647) I. Device Description: The N Latex FLC Kappa and N Latex FLC Lambda assays are comprised of the following reagents in liquid form: N latex FLC reagents: Consist of suspension of polysterene particles coated with monoclonal antibodies (mouse) to either human FLC Kappa or human FLC Lambda; conjugate of S-adenosyl-cysteine/porcine thyreoglobin (<0.1 g/L); conjugate of S-adenosyl-
L-homocysteine hydrolase (<100 U/mL); dithiothreitol (<0.5 g/L). Preservative: Sodium azide (<1 g/L) N FLC Supplementary Reagents A and B: N FLC Supplementary Reagent A contains mouse immunoglobulin in buffered solution and N FLC Supplementary Reagent B: consist of a buffered salt solution containing detergent. Preservatives in both Supplemntary reagents: Sodium azide (<1 g/L). N FLC Standard SL: Contains human free light chains proteins, human serum albumin and protease inhibitors. N FLC Controls SL1 and SL2: contains human free light chain proteins, human serum albumin and protease inhibitors. J. Substantial Equivalence Information: 1. Predicate device names and 510(k) numbers: The Binding Site Freelite® Human Kappa Free Kit for use on the Siemens BN™ II - K031016 The Binding Site Freelite® Human Lambda Free Kit for use on the Siemens BN™ II - K031016 4 2. Comparison with predicate: Kappa and Lambda Reagents: Similarities Item Device N Latex FLC Kappa N Latex FLC Lambda Predicate Freelite® Human Kappa Free and Freelite® Human Lambda Free kits on the Siemens BN™II Analyte Kappa: Kappa FLC Lambda: Lambda FLC Same Measurement Quantitative Same Detection Method Nephelometric Same Differences Item Device Predicate Indication for use In-vitro diagnostic reagents for the quantitative determination of free light chains (FLC), type kappa or type lambda, in human serum and EDTA plasma by means of particle- enhanced immunonephelometry using the BN Systems. FLC measurements are used as an aid in the diagnosis of multiple myeloma (MM) and amyloidosis (AL). This kit is intended for the quantitation of kappa free light chains or lambda free light chains in serum and urine on the Siemens BN™ II. Measurement of free light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom’s macroglobulinemia, AL amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus in conjunction with other laboratory and clinical findings. Sample type Serum and EDTA plasma Serum and urine Detection Antibody Kappa: Monoclonal mouse anti-human FLC kappa antibody onto polysterene particles Lambda: Monoclonal mouse anti-human FLC lambda antibody onto polysterene particles Kappa: Polyclonal sheep anti-human kappa antibody coated onto latex particles Lambda: Polyclonal sheep anti-human lambda antibody coated onto latex particles 5 Differences Item Device Predicate Analytical Measuring ranges (Calibrator lot dependent): Kappa: 3.4 – 110 mg/L Lambda: 1.9 – 60 mg/L Kappa: 5.9 – 190 mg/L Lambda: 5.0 – 160 mg/L Instrument System Siemens BN II and BN ProSpec Systems Siemens BN II Reference Interval Kappa: 8.24 – 28.90 mg/L Lambda: 9.10 – 32.60 mg/L Ratio: 0.53 – 1.51 Kappa: 3.30 to 19.40 mg/L Lambda: 5.71 to 26.30 mg/L Ratio: 0.26 – 1.65 Calibrators: Similarities Item Device N Latex FLC Standard SL for the BN Systems Predicate Human Kappa Free Standard and Human Lambda Free Standard on the Siemens BN™II Number of Levels One Same Reference material Internal reference preparation Same Differences Item Device N Latex FLC Standard SL for the BN Systems Predicate Human Kappa Free Standard and Human Lambda Free Standard on the Siemens BN™II Indication for use Establishment of reference curves for the determination of free light chains (FLC), type kappa and type lambda on the BN Systems. Used for the establishment of reference curves for the determination of Freelite® Kappa and Lambda light chains on the BN II System. Matrix Consists of a stabilized liquid containing human free light chain proteins, human serum albumin and protease inhibitors. Contains Consists of human sera that contain kappa free light chain and lambda free light chain respectively. They are 6 Differences Item Device N Latex FLC Standard SL for the BN Systems Predicate Human Kappa Free Standard and Human Lambda Free Standard on the Siemens BN™II sodium azide (<1 g/L) as a preservative. supplied in a stabilized liquid form and contain 0.099% sodium azide, 0.1% E- amino-n-caproic acid (EACA) and 0.01% benzamidine as preservatives. Volume 3 x 1.0 mL 2 x 1.0 mL Analytical values (Control lot dependent) Kappa: 22 mg/L Lambda: 32 mg/L Kappa: 19.99 mg/L Lambda: 16.21 mg/L Controls: Differences Item Device N FLC Control SL 1 N FLC Control SL 2 Predicate Human Kappa Free Control, Human Kappa Free High Control, Human Lambda Free Control and Human Lambda Free High Control Indications for Use The N FLC Controls SL1 and SL2 are for use as assayed accuracy controls and precision controls in the determination of free light chains (FLC), type kappa and type lambda by immunonephelometry with the BN Systems. Used as quality controls for the Freelite® Kappa and Lambda assays on the Siemens BN II Matrix Controls are stabilized liquids containing human free light chain proteins, human serum albumin and protease inhibitors. The concentration of the free light chains (FLC), type kappa and type lambda is Controls consist of human sera
Type of test: |
idK171742_s0_e2000 | K171742.txt | classification | Class II | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K171742 B. Purpose for Submission: New device on two previously cleared instruments C. Measurand: Kappa (κ) Free Light Chain (FLC) Lambda (λ) Free Light Chain (FLC) D. Type of Test: Nephelometry, quantitative E. Applicant: Siemens Healthcare Diagnostics Products GmbH F. Proprietary and Established Names: N Latex FLC Kappa assay N Latex FLC Lambda assay N FLC Standard SL N FLC Control SL1 & SL2 G. Regulatory Information: 1. Regulation section: 21 CFR § 866.5550 – Immunoglobulin (light chain specific) immunological test system 21 CFR § 862.1660 – Quality Control Material (assayed and unassayed) 2. Classification: Class II, test systems 2 3. Product code: DFH, Kappa, antigen, antiserum, control DEH, Lambda, antigen, antiserum, control 4. Panel: Immunology (82) H. Intended Use: 1. Intended uses: N Latex FLC Kappa and N Latex FLC Lambda assays In-vitro diagnostic reagents for the quantitative determination of free light chains (FLC), type kappa or type lambda in human serum and EDTA-plasma by means of particle- enhanced immunonephelometry using the BN Systems. FLC measurements are used as an aid in the diagnosis of multiple myeloma (MM) and amyloidosis (AL). N FLC Supplementary Reagent Supplementary reagent for the immunonephelometric determination of free light chains (FLC), type kappa and type lambda on BN Systems. A mixture of both supplementary reagents is used to suppress interference by rheumatoid factors and human anti-mouse antibodies (HAMA). N FLC Standard SL Establishment of reference curves for the determination of free light chains (FLC), type kappa and type lambda on the BN Systems. N FLC Control SL1 and SL2 The N FLC Controls SL1 and SL2 are for use as assayed accuracy controls and precision controls in the determination of free light chains (FLC), type kappa and type lambda by immunonephelometry with the BN Systems. 2. Indications for use: Same as Intended Uses 3. Special conditions for use statements: For prescription use only 3 Warning: The result of the FLC Kappa or FLC Lambda in a given specimen determined with assays and or instrument plarforms from different manufacturers can vary due to differences in assay methods and reagent specificity. The results reported by the laboratory to the physician must include the identity of the FLC Kappa or FLC Lambda assay used. Values obtained with different assay methods cannot be used interchangeably. 4. Special instrument requirements: BN II (K943997) and BN ProSpec® Systems (K001647) I. Device Description: The N Latex FLC Kappa and N Latex FLC Lambda assays are comprised of the following reagents in liquid form: N latex FLC reagents: Consist of suspension of polysterene particles coated with monoclonal antibodies (mouse) to either human FLC Kappa or human FLC Lambda; conjugate of S-adenosyl-cysteine/porcine thyreoglobin (<0.1 g/L); conjugate of S-adenosyl-
L-homocysteine hydrolase (<100 U/mL); dithiothreitol (<0.5 g/L). Preservative: Sodium azide (<1 g/L) N FLC Supplementary Reagents A and B: N FLC Supplementary Reagent A contains mouse immunoglobulin in buffered solution and N FLC Supplementary Reagent B: consist of a buffered salt solution containing detergent. Preservatives in both Supplemntary reagents: Sodium azide (<1 g/L). N FLC Standard SL: Contains human free light chains proteins, human serum albumin and protease inhibitors. N FLC Controls SL1 and SL2: contains human free light chain proteins, human serum albumin and protease inhibitors. J. Substantial Equivalence Information: 1. Predicate device names and 510(k) numbers: The Binding Site Freelite® Human Kappa Free Kit for use on the Siemens BN™ II - K031016 The Binding Site Freelite® Human Lambda Free Kit for use on the Siemens BN™ II - K031016 4 2. Comparison with predicate: Kappa and Lambda Reagents: Similarities Item Device N Latex FLC Kappa N Latex FLC Lambda Predicate Freelite® Human Kappa Free and Freelite® Human Lambda Free kits on the Siemens BN™II Analyte Kappa: Kappa FLC Lambda: Lambda FLC Same Measurement Quantitative Same Detection Method Nephelometric Same Differences Item Device Predicate Indication for use In-vitro diagnostic reagents for the quantitative determination of free light chains (FLC), type kappa or type lambda, in human serum and EDTA plasma by means of particle- enhanced immunonephelometry using the BN Systems. FLC measurements are used as an aid in the diagnosis of multiple myeloma (MM) and amyloidosis (AL). This kit is intended for the quantitation of kappa free light chains or lambda free light chains in serum and urine on the Siemens BN™ II. Measurement of free light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom’s macroglobulinemia, AL amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus in conjunction with other laboratory and clinical findings. Sample type Serum and EDTA plasma Serum and urine Detection Antibody Kappa: Monoclonal mouse anti-human FLC kappa antibody onto polysterene particles Lambda: Monoclonal mouse anti-human FLC lambda antibody onto polysterene particles Kappa: Polyclonal sheep anti-human kappa antibody coated onto latex particles Lambda: Polyclonal sheep anti-human lambda antibody coated onto latex particles 5 Differences Item Device Predicate Analytical Measuring ranges (Calibrator lot dependent): Kappa: 3.4 – 110 mg/L Lambda: 1.9 – 60 mg/L Kappa: 5.9 – 190 mg/L Lambda: 5.0 – 160 mg/L Instrument System Siemens BN II and BN ProSpec Systems Siemens BN II Reference Interval Kappa: 8.24 – 28.90 mg/L Lambda: 9.10 – 32.60 mg/L Ratio: 0.53 – 1.51 Kappa: 3.30 to 19.40 mg/L Lambda: 5.71 to 26.30 mg/L Ratio: 0.26 – 1.65 Calibrators: Similarities Item Device N Latex FLC Standard SL for the BN Systems Predicate Human Kappa Free Standard and Human Lambda Free Standard on the Siemens BN™II Number of Levels One Same Reference material Internal reference preparation Same Differences Item Device N Latex FLC Standard SL for the BN Systems Predicate Human Kappa Free Standard and Human Lambda Free Standard on the Siemens BN™II Indication for use Establishment of reference curves for the determination of free light chains (FLC), type kappa and type lambda on the BN Systems. Used for the establishment of reference curves for the determination of Freelite® Kappa and Lambda light chains on the BN II System. Matrix Consists of a stabilized liquid containing human free light chain proteins, human serum albumin and protease inhibitors. Contains Consists of human sera that contain kappa free light chain and lambda free light chain respectively. They are 6 Differences Item Device N Latex FLC Standard SL for the BN Systems Predicate Human Kappa Free Standard and Human Lambda Free Standard on the Siemens BN™II sodium azide (<1 g/L) as a preservative. supplied in a stabilized liquid form and contain 0.099% sodium azide, 0.1% E- amino-n-caproic acid (EACA) and 0.01% benzamidine as preservatives. Volume 3 x 1.0 mL 2 x 1.0 mL Analytical values (Control lot dependent) Kappa: 22 mg/L Lambda: 32 mg/L Kappa: 19.99 mg/L Lambda: 16.21 mg/L Controls: Differences Item Device N FLC Control SL 1 N FLC Control SL 2 Predicate Human Kappa Free Control, Human Kappa Free High Control, Human Lambda Free Control and Human Lambda Free High Control Indications for Use The N FLC Controls SL1 and SL2 are for use as assayed accuracy controls and precision controls in the determination of free light chains (FLC), type kappa and type lambda by immunonephelometry with the BN Systems. Used as quality controls for the Freelite® Kappa and Lambda assays on the Siemens BN II Matrix Controls are stabilized liquids containing human free light chain proteins, human serum albumin and protease inhibitors. The concentration of the free light chains (FLC), type kappa and type lambda is Controls consist of human sera
Classification: |