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based-fda

@article{arora2024simple,
  title={Simple linear attention language models balance the recall-throughput tradeoff},
  author={Arora, Simran and Eyuboglu, Sabri and Zhang, Michael and Timalsina, Aman and Alberti, Silas and Zinsley, Dylan and Zou, James and Rudra, Atri and Ré, Christopher},
  journal={arXiv:2402.18668},
  year={2024}
}

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These language model checkpoints are trained at the 360M and 1.3Bn parameter scales for up to 50Bn tokens on the Pile corpus, for research purposes. • 15 items • Updated Oct 18 • 9

Just Read Twice!

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Here we provide models and benchmarks for the Just Read Twice work: https://arxiv.org/abs/2407.05483 • 16 items • Updated Jul 11

doc_id stringclasses 201 values	file_name stringclasses 100 values	key stringclasses 15 values	value stringlengths 1 1.66k	text stringlengths 2.2k 9.79k
idK153137_s0_e2000	K153137.txt	purpose for submission	Clearance of a new device	STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K153137 B. Purpose for Submission: Clearance of a new device C. Measurand: Anti-PF4/Heparin Total Antibodies D. Type of Test: Automated, latex enhanced immuno-turbidimetric assay E. Applicant: Instrumentation Laboratory (IL) Co. F. Proprietary and Established Names: HemosIL HIT‐Ab(PF4‐H) HemosIL HIT‐Ab(PF4‐H) Controls G. Regulatory Information: 1. Regulation section: 21 CFR 864.7695, Platelet factor 4 radioimmunoassay 21 CFR 864.5425, Multipurpose system for in vitro coagulation studies 2. Classification: Class II 3. Product code: 2 LCO, Platelet factor 4 radioimmunoassay GGN, Plasma, Coagulation Control 4. Panel: Hematology (81) H. Intended Use: 1. Intended use(s): HemosIL HIT-Ab(PF4-H) is a qualitative, fully automated, latex enhanced immunoassay for the detection of anti-platelet factor 4/heparin (PF4/H) antibodies. The assay is for use in human 3.2% or 3.8% citrated plasma on the ACL TOP® Family of instruments in a laboratory setting. The result provided by the assay should be interpreted as either positive or negative based on the assay cut-off (1.0 U/mL). The positive or negative result aids in determining the risk for heparin induced thrombocytopenia (HIT) when used in conjunction with other laboratory and clinical findings. Anti-PF4/Heparin antibodies are commonly found in patients with HIT. For use in adult population suspected of HIT. Not for use in isolation to exclude HIT. HemoslL HIT-Ab(PF4-H) Controls are for the Quality Control of the HemosIL HIT-Ab(PF4- H) assay as performed on the ACL TOP® Family of instruments. For prescription use. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use 4. Special instrument requirements: ACL TOP® Family Instruments I. Device Description: The HemosIL HIT-Ab(PF4-H) kit is a latex particle enhanced immuno-turbidimetric assay to detect total anti‐PF4/Heparin antibodies found in HIT patients. A monoclonal 3 antibody that mimics human HIT antibodies is coated onto latex particles. The HemosIL HIT-Ab(PF4-H) kit consists of: Latex Reagent: Suspension of polystyrene latex particles coated with purified mouse monoclonal anti-PF4-Heparin in Tris buffer, containing bovine serum albumin, stabilizers and preservative. Stabilizer: PBS buffer containing bovine serum albumin, stabilizers and preservative. Complex: Solution of PF4-PVS complex (PF4 from human platelets complexed to PVS), in PBS buffer containing bovine serum albumin, stabilizers and preservative. Contains 0.02% Bronidox™ as a preservative. Calibrator: Lyophilized solution of a monoclonal anti- PF4-Heparin antibody in Tris buffer containing bovine serum albumin, stabilizers and preservative. Controls: The Low and High HIT‐Ab(PF4‐H) Controls are prepared by means of a dedicated process and contain different concentrations of humanized monoclonal anti‐PF4‐Heparin human IgG. • Low HIT Control: Control intended for the assessment of precision and accuracy of the assay at PF4/H antibody levels at or below the cut‐off. • High HIT Control: Control intended for the assessment of precision and accuracy of the assay at abnormal PF4/H antibody levels. J. Substantial Equivalence Information: 1. Predicate device name(s): Asserachrom HPIA Test kit from Diagnostica Stago 2. Predicate 510(k) number(s): K003767 3. Comparison with predicate: 4 Similarities Item Device Predicate Trade Names HemosIL HIT-Ab(PF4-H) HemosIL HIT-Ab(PF4-H) Controls (K153137) Asserachrom HPIA Test Kit (kit includes two control levels) (K003767) Measurand Anti-PF4/Heparin Total Antibodies Anti‐PF4/Heparin Total Antibodies Detection Method Absorbance (Turbimetric) Absorbance (Colorimetric) Intended Use HemosIL HIT-Ab(PF4-H) is a qualitative, fully automated, latex enhanced immunoassay for the detection of anti-platelet factor 4/heparin (PF4/H) antibodies. The assay is for use in human 3.2% or 3.8% citrated plasma on the ACL TOP® Family of instruments in a laboratory setting. The result provided by the assay should be interpreted as either positive or negative based on the assay cut-off (1.0 U/mL). The positive or negative result aids in determining the risk for heparin induced thrombocytopenia (HIT) when used in conjunction with other laboratory and clinical findings. Anti-PF4/Heparin antibodies are commonly found in patients with HIT. For use in adult population suspected of HIT. Not for use in isolation to exclude HIT. HemosIL HIT-Ab(PF4-H) Controls are for the Quality Control of the HemosIL HIT-Ab(PF4-H) assay as performed on the ACL TOP Family of instruments. For prescription use. The ASSERACHROM® HPIA Test Kit is intended for use as a qualitative procedure for the detection of anti‐heparin‐platelet factor 4 (anti-Heparin-PF4) antibodies in citrated plasma or serum by the sandwich technique of enzyme-linked immunosorbent assay (ELISA). The presence in plasma or serum of anti-Heparin-PF4 antibodies, together with a concurrent drop in platelet count, is generally associated with Type II heparin‐induced thrombocytopenia (Type II HIT), a condition that occurs during heparin therapy, leading to arterial or venous thrombosis. Assay Type Qualitative Qualitative Differences Item Device Predicate Sample Types Citrated human plasma only Citrated human plasma or serum Cut‐off Fixed clinical cut‐off: ≥ 1.0 U/mL Variable clinical cut‐off Cut‐off is lot and plate dependent. Every time a plate is processed, the cut‐off for this plate is calculated as the percentage (X%) of the value 5 Differences Item Device Predicate obtained for the reagent supplied with the kit. This percentage is provided for each lot through the insert sheets. Methodology Latex‐enhanced immuno-turbidimetric assay Two‐step enzyme immunoassay (EIA) sandwich method with a final colorimetric detection. Antibodies Purified mouse monoclonal anti-PF4-Heparin Goat anti-human antibodies to IgG, IgA and IgM Controls Controls sold separately: - Low Level at or below the cut-off - High Level at abnormal anti-PF4/H antibody level. Controls included in test kit: - Negative level - Positive level Calibrator Traceability The reported values for the kit calibrator are determined over multiple runs on the ACL TOP Family of instruments using specific lots of reagents and against an internal House Standard. Since an HIT International Standard is not currently available, arbitrary units (U/mL) have been established. Not Applicable K. Standard/Guidance Document Referenced (if applicable): EP05-A3; Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline; 2014 EP06-A; Evaluation of the Linearity of Quantitative Measurement Procedures; a Statistical Approach; Approved Guideline; 2003 EP07-A2; Interference Testing in Clinical Chemistry; Approved Guideline; 2005 EP09-A3; Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline; 2013 EP12-A2; User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline; 2008 EP14-A3; Evaluation of Commutability of Processed Samples; Approved Guideline; 2013 EP17-A2; Evaluation of Detection Capability For Clinical Laboratory Measurement Procedures; Approved Guideline; 2012 EP24-A2; Assessment of Diagnostic Accuracy of Laboratory Tests Using receiver Operating 6 Characteristic Curves; Approved Guideline; 2011 EP25-A3; Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline; 2009 EP28-A3C; Defining, Establishing and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline; 2010 L. Test Principle: The HemosIL HIT-Ab(PF4-H) kit is a latex particle enhanced immuno-turbidimetric assay to detect total Anti‐PF4/Heparin (PF4/H) antibodies found in HIT patients. A monoclonal antibody that mimics human HIT antibodies Purpose for submission:
idK153137_s0_e2000	K153137.txt	measurand	Anti-PF4/Heparin Total Antibodies	STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K153137 B. Purpose for Submission: Clearance of a new device C. Measurand: Anti-PF4/Heparin Total Antibodies D. Type of Test: Automated, latex enhanced immuno-turbidimetric assay E. Applicant: Instrumentation Laboratory (IL) Co. F. Proprietary and Established Names: HemosIL HIT‐Ab(PF4‐H) HemosIL HIT‐Ab(PF4‐H) Controls G. Regulatory Information: 1. Regulation section: 21 CFR 864.7695, Platelet factor 4 radioimmunoassay 21 CFR 864.5425, Multipurpose system for in vitro coagulation studies 2. Classification: Class II 3. Product code: 2 LCO, Platelet factor 4 radioimmunoassay GGN, Plasma, Coagulation Control 4. Panel: Hematology (81) H. Intended Use: 1. Intended use(s): HemosIL HIT-Ab(PF4-H) is a qualitative, fully automated, latex enhanced immunoassay for the detection of anti-platelet factor 4/heparin (PF4/H) antibodies. The assay is for use in human 3.2% or 3.8% citrated plasma on the ACL TOP® Family of instruments in a laboratory setting. The result provided by the assay should be interpreted as either positive or negative based on the assay cut-off (1.0 U/mL). The positive or negative result aids in determining the risk for heparin induced thrombocytopenia (HIT) when used in conjunction with other laboratory and clinical findings. Anti-PF4/Heparin antibodies are commonly found in patients with HIT. For use in adult population suspected of HIT. Not for use in isolation to exclude HIT. HemoslL HIT-Ab(PF4-H) Controls are for the Quality Control of the HemosIL HIT-Ab(PF4- H) assay as performed on the ACL TOP® Family of instruments. For prescription use. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use 4. Special instrument requirements: ACL TOP® Family Instruments I. Device Description: The HemosIL HIT-Ab(PF4-H) kit is a latex particle enhanced immuno-turbidimetric assay to detect total anti‐PF4/Heparin antibodies found in HIT patients. A monoclonal 3 antibody that mimics human HIT antibodies is coated onto latex particles. The HemosIL HIT-Ab(PF4-H) kit consists of: Latex Reagent: Suspension of polystyrene latex particles coated with purified mouse monoclonal anti-PF4-Heparin in Tris buffer, containing bovine serum albumin, stabilizers and preservative. Stabilizer: PBS buffer containing bovine serum albumin, stabilizers and preservative. Complex: Solution of PF4-PVS complex (PF4 from human platelets complexed to PVS), in PBS buffer containing bovine serum albumin, stabilizers and preservative. Contains 0.02% Bronidox™ as a preservative. Calibrator: Lyophilized solution of a monoclonal anti- PF4-Heparin antibody in Tris buffer containing bovine serum albumin, stabilizers and preservative. Controls: The Low and High HIT‐Ab(PF4‐H) Controls are prepared by means of a dedicated process and contain different concentrations of humanized monoclonal anti‐PF4‐Heparin human IgG. • Low HIT Control: Control intended for the assessment of precision and accuracy of the assay at PF4/H antibody levels at or below the cut‐off. • High HIT Control: Control intended for the assessment of precision and accuracy of the assay at abnormal PF4/H antibody levels. J. Substantial Equivalence Information: 1. Predicate device name(s): Asserachrom HPIA Test kit from Diagnostica Stago 2. Predicate 510(k) number(s): K003767 3. Comparison with predicate: 4 Similarities Item Device Predicate Trade Names HemosIL HIT-Ab(PF4-H) HemosIL HIT-Ab(PF4-H) Controls (K153137) Asserachrom HPIA Test Kit (kit includes two control levels) (K003767) Measurand Anti-PF4/Heparin Total Antibodies Anti‐PF4/Heparin Total Antibodies Detection Method Absorbance (Turbimetric) Absorbance (Colorimetric) Intended Use HemosIL HIT-Ab(PF4-H) is a qualitative, fully automated, latex enhanced immunoassay for the detection of anti-platelet factor 4/heparin (PF4/H) antibodies. The assay is for use in human 3.2% or 3.8% citrated plasma on the ACL TOP® Family of instruments in a laboratory setting. The result provided by the assay should be interpreted as either positive or negative based on the assay cut-off (1.0 U/mL). The positive or negative result aids in determining the risk for heparin induced thrombocytopenia (HIT) when used in conjunction with other laboratory and clinical findings. Anti-PF4/Heparin antibodies are commonly found in patients with HIT. For use in adult population suspected of HIT. Not for use in isolation to exclude HIT. HemosIL HIT-Ab(PF4-H) Controls are for the Quality Control of the HemosIL HIT-Ab(PF4-H) assay as performed on the ACL TOP Family of instruments. For prescription use. The ASSERACHROM® HPIA Test Kit is intended for use as a qualitative procedure for the detection of anti‐heparin‐platelet factor 4 (anti-Heparin-PF4) antibodies in citrated plasma or serum by the sandwich technique of enzyme-linked immunosorbent assay (ELISA). The presence in plasma or serum of anti-Heparin-PF4 antibodies, together with a concurrent drop in platelet count, is generally associated with Type II heparin‐induced thrombocytopenia (Type II HIT), a condition that occurs during heparin therapy, leading to arterial or venous thrombosis. Assay Type Qualitative Qualitative Differences Item Device Predicate Sample Types Citrated human plasma only Citrated human plasma or serum Cut‐off Fixed clinical cut‐off: ≥ 1.0 U/mL Variable clinical cut‐off Cut‐off is lot and plate dependent. Every time a plate is processed, the cut‐off for this plate is calculated as the percentage (X%) of the value 5 Differences Item Device Predicate obtained for the reagent supplied with the kit. This percentage is provided for each lot through the insert sheets. Methodology Latex‐enhanced immuno-turbidimetric assay Two‐step enzyme immunoassay (EIA) sandwich method with a final colorimetric detection. Antibodies Purified mouse monoclonal anti-PF4-Heparin Goat anti-human antibodies to IgG, IgA and IgM Controls Controls sold separately: - Low Level at or below the cut-off - High Level at abnormal anti-PF4/H antibody level. Controls included in test kit: - Negative level - Positive level Calibrator Traceability The reported values for the kit calibrator are determined over multiple runs on the ACL TOP Family of instruments using specific lots of reagents and against an internal House Standard. Since an HIT International Standard is not currently available, arbitrary units (U/mL) have been established. Not Applicable K. Standard/Guidance Document Referenced (if applicable): EP05-A3; Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline; 2014 EP06-A; Evaluation of the Linearity of Quantitative Measurement Procedures; a Statistical Approach; Approved Guideline; 2003 EP07-A2; Interference Testing in Clinical Chemistry; Approved Guideline; 2005 EP09-A3; Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline; 2013 EP12-A2; User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline; 2008 EP14-A3; Evaluation of Commutability of Processed Samples; Approved Guideline; 2013 EP17-A2; Evaluation of Detection Capability For Clinical Laboratory Measurement Procedures; Approved Guideline; 2012 EP24-A2; Assessment of Diagnostic Accuracy of Laboratory Tests Using receiver Operating 6 Characteristic Curves; Approved Guideline; 2011 EP25-A3; Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline; 2009 EP28-A3C; Defining, Establishing and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline; 2010 L. Test Principle: The HemosIL HIT-Ab(PF4-H) kit is a latex particle enhanced immuno-turbidimetric assay to detect total Anti‐PF4/Heparin (PF4/H) antibodies found in HIT patients. A monoclonal antibody that mimics human HIT antibodies Measurand:
idK153137_s0_e2000	K153137.txt	type of test	Automated, latex enhanced immuno-turbidimetric assay	SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K153137 B. Purpose for Submission: Clearance of a new device C. Measurand: Anti-PF4/Heparin Total Antibodies D. Type of Test: Automated, latex enhanced immuno-turbidimetric assay E. Applicant: Instrumentation Laboratory (IL) Co. F. Proprietary and Established Names: HemosIL HIT‐Ab(PF4‐H) HemosIL HIT‐Ab(PF4‐H) Controls G. Regulatory Information: 1. Regulation section: 21 CFR 864.7695, Platelet factor 4 radioimmunoassay 21 CFR 864.5425, Multipurpose system for in vitro coagulation studies 2. Classification: Class II 3. Product code: 2 LCO, Platelet factor 4 radioimmunoassay GGN, Plasma, Coagulation Control 4. Panel: Hematology (81) H. Intended Use: 1. Intended use(s): HemosIL HIT-Ab(PF4-H) is a qualitative, fully automated, latex enhanced immunoassay for the detection of anti-platelet factor 4/heparin (PF4/H) antibodies. The assay is for use in human 3.2% or 3.8% citrated plasma on the ACL TOP® Family of instruments in a laboratory setting. The result provided by the assay should be interpreted as either positive or negative based on the assay cut-off (1.0 U/mL). The positive or negative result aids in determining the risk for heparin induced thrombocytopenia (HIT) when used in conjunction with other laboratory and clinical findings. Anti-PF4/Heparin antibodies are commonly found in patients with HIT. For use in adult population suspected of HIT. Not for use in isolation to exclude HIT. HemoslL HIT-Ab(PF4-H) Controls are for the Quality Control of the HemosIL HIT-Ab(PF4- H) assay as performed on the ACL TOP® Family of instruments. For prescription use. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use 4. Special instrument requirements: ACL TOP® Family Instruments I. Device Description: The HemosIL HIT-Ab(PF4-H) kit is a latex particle enhanced immuno-turbidimetric assay to detect total anti‐PF4/Heparin antibodies found in HIT patients. A monoclonal 3 antibody that mimics human HIT antibodies is coated onto latex particles. The HemosIL HIT-Ab(PF4-H) kit consists of: Latex Reagent: Suspension of polystyrene latex particles coated with purified mouse monoclonal anti-PF4-Heparin in Tris buffer, containing bovine serum albumin, stabilizers and preservative. Stabilizer: PBS buffer containing bovine serum albumin, stabilizers and preservative. Complex: Solution of PF4-PVS complex (PF4 from human platelets complexed to PVS), in PBS buffer containing bovine serum albumin, stabilizers and preservative. Contains 0.02% Bronidox™ as a preservative. Calibrator: Lyophilized solution of a monoclonal anti- PF4-Heparin antibody in Tris buffer containing bovine serum albumin, stabilizers and preservative. Controls: The Low and High HIT‐Ab(PF4‐H) Controls are prepared by means of a dedicated process and contain different concentrations of humanized monoclonal anti‐PF4‐Heparin human IgG. • Low HIT Control: Control intended for the assessment of precision and accuracy of the assay at PF4/H antibody levels at or below the cut‐off. • High HIT Control: Control intended for the assessment of precision and accuracy of the assay at abnormal PF4/H antibody levels. J. Substantial Equivalence Information: 1. Predicate device name(s): Asserachrom HPIA Test kit from Diagnostica Stago 2. Predicate 510(k) number(s): K003767 3. Comparison with predicate: 4 Similarities Item Device Predicate Trade Names HemosIL HIT-Ab(PF4-H) HemosIL HIT-Ab(PF4-H) Controls (K153137) Asserachrom HPIA Test Kit (kit includes two control levels) (K003767) Measurand Anti-PF4/Heparin Total Antibodies Anti‐PF4/Heparin Total Antibodies Detection Method Absorbance (Turbimetric) Absorbance (Colorimetric) Intended Use HemosIL HIT-Ab(PF4-H) is a qualitative, fully automated, latex enhanced immunoassay for the detection of anti-platelet factor 4/heparin (PF4/H) antibodies. The assay is for use in human 3.2% or 3.8% citrated plasma on the ACL TOP® Family of instruments in a laboratory setting. The result provided by the assay should be interpreted as either positive or negative based on the assay cut-off (1.0 U/mL). The positive or negative result aids in determining the risk for heparin induced thrombocytopenia (HIT) when used in conjunction with other laboratory and clinical findings. Anti-PF4/Heparin antibodies are commonly found in patients with HIT. For use in adult population suspected of HIT. Not for use in isolation to exclude HIT. HemosIL HIT-Ab(PF4-H) Controls are for the Quality Control of the HemosIL HIT-Ab(PF4-H) assay as performed on the ACL TOP Family of instruments. For prescription use. The ASSERACHROM® HPIA Test Kit is intended for use as a qualitative procedure for the detection of anti‐heparin‐platelet factor 4 (anti-Heparin-PF4) antibodies in citrated plasma or serum by the sandwich technique of enzyme-linked immunosorbent assay (ELISA). The presence in plasma or serum of anti-Heparin-PF4 antibodies, together with a concurrent drop in platelet count, is generally associated with Type II heparin‐induced thrombocytopenia (Type II HIT), a condition that occurs during heparin therapy, leading to arterial or venous thrombosis. Assay Type Qualitative Qualitative Differences Item Device Predicate Sample Types Citrated human plasma only Citrated human plasma or serum Cut‐off Fixed clinical cut‐off: ≥ 1.0 U/mL Variable clinical cut‐off Cut‐off is lot and plate dependent. Every time a plate is processed, the cut‐off for this plate is calculated as the percentage (X%) of the value 5 Differences Item Device Predicate obtained for the reagent supplied with the kit. This percentage is provided for each lot through the insert sheets. Methodology Latex‐enhanced immuno-turbidimetric assay Two‐step enzyme immunoassay (EIA) sandwich method with a final colorimetric detection. Antibodies Purified mouse monoclonal anti-PF4-Heparin Goat anti-human antibodies to IgG, IgA and IgM Controls Controls sold separately: - Low Level at or below the cut-off - High Level at abnormal anti-PF4/H antibody level. Controls included in test kit: - Negative level - Positive level Calibrator Traceability The reported values for the kit calibrator are determined over multiple runs on the ACL TOP Family of instruments using specific lots of reagents and against an internal House Standard. Since an HIT International Standard is not currently available, arbitrary units (U/mL) have been established. Not Applicable K. Standard/Guidance Document Referenced (if applicable): EP05-A3; Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline; 2014 EP06-A; Evaluation of the Linearity of Quantitative Measurement Procedures; a Statistical Approach; Approved Guideline; 2003 EP07-A2; Interference Testing in Clinical Chemistry; Approved Guideline; 2005 EP09-A3; Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline; 2013 EP12-A2; User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline; 2008 EP14-A3; Evaluation of Commutability of Processed Samples; Approved Guideline; 2013 EP17-A2; Evaluation of Detection Capability For Clinical Laboratory Measurement Procedures; Approved Guideline; 2012 EP24-A2; Assessment of Diagnostic Accuracy of Laboratory Tests Using receiver Operating 6 Characteristic Curves; Approved Guideline; 2011 EP25-A3; Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline; 2009 EP28-A3C; Defining, Establishing and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline; 2010 L. Test Principle: The HemosIL HIT-Ab(PF4-H) kit is a latex particle enhanced immuno-turbidimetric assay to detect total Anti‐PF4/Heparin (PF4/H) antibodies found in HIT patients. A monoclonal antibody that mimics human HIT antibodies Type of test:
idK153137_s0_e2000	K153137.txt	classification	Class II	) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K153137 B. Purpose for Submission: Clearance of a new device C. Measurand: Anti-PF4/Heparin Total Antibodies D. Type of Test: Automated, latex enhanced immuno-turbidimetric assay E. Applicant: Instrumentation Laboratory (IL) Co. F. Proprietary and Established Names: HemosIL HIT‐Ab(PF4‐H) HemosIL HIT‐Ab(PF4‐H) Controls G. Regulatory Information: 1. Regulation section: 21 CFR 864.7695, Platelet factor 4 radioimmunoassay 21 CFR 864.5425, Multipurpose system for in vitro coagulation studies 2. Classification: Class II 3. Product code: 2 LCO, Platelet factor 4 radioimmunoassay GGN, Plasma, Coagulation Control 4. Panel: Hematology (81) H. Intended Use: 1. Intended use(s): HemosIL HIT-Ab(PF4-H) is a qualitative, fully automated, latex enhanced immunoassay for the detection of anti-platelet factor 4/heparin (PF4/H) antibodies. The assay is for use in human 3.2% or 3.8% citrated plasma on the ACL TOP® Family of instruments in a laboratory setting. The result provided by the assay should be interpreted as either positive or negative based on the assay cut-off (1.0 U/mL). The positive or negative result aids in determining the risk for heparin induced thrombocytopenia (HIT) when used in conjunction with other laboratory and clinical findings. Anti-PF4/Heparin antibodies are commonly found in patients with HIT. For use in adult population suspected of HIT. Not for use in isolation to exclude HIT. HemoslL HIT-Ab(PF4-H) Controls are for the Quality Control of the HemosIL HIT-Ab(PF4- H) assay as performed on the ACL TOP® Family of instruments. For prescription use. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use 4. Special instrument requirements: ACL TOP® Family Instruments I. Device Description: The HemosIL HIT-Ab(PF4-H) kit is a latex particle enhanced immuno-turbidimetric assay to detect total anti‐PF4/Heparin antibodies found in HIT patients. A monoclonal 3 antibody that mimics human HIT antibodies is coated onto latex particles. The HemosIL HIT-Ab(PF4-H) kit consists of: Latex Reagent: Suspension of polystyrene latex particles coated with purified mouse monoclonal anti-PF4-Heparin in Tris buffer, containing bovine serum albumin, stabilizers and preservative. Stabilizer: PBS buffer containing bovine serum albumin, stabilizers and preservative. Complex: Solution of PF4-PVS complex (PF4 from human platelets complexed to PVS), in PBS buffer containing bovine serum albumin, stabilizers and preservative. Contains 0.02% Bronidox™ as a preservative. Calibrator: Lyophilized solution of a monoclonal anti- PF4-Heparin antibody in Tris buffer containing bovine serum albumin, stabilizers and preservative. Controls: The Low and High HIT‐Ab(PF4‐H) Controls are prepared by means of a dedicated process and contain different concentrations of humanized monoclonal anti‐PF4‐Heparin human IgG. • Low HIT Control: Control intended for the assessment of precision and accuracy of the assay at PF4/H antibody levels at or below the cut‐off. • High HIT Control: Control intended for the assessment of precision and accuracy of the assay at abnormal PF4/H antibody levels. J. Substantial Equivalence Information: 1. Predicate device name(s): Asserachrom HPIA Test kit from Diagnostica Stago 2. Predicate 510(k) number(s): K003767 3. Comparison with predicate: 4 Similarities Item Device Predicate Trade Names HemosIL HIT-Ab(PF4-H) HemosIL HIT-Ab(PF4-H) Controls (K153137) Asserachrom HPIA Test Kit (kit includes two control levels) (K003767) Measurand Anti-PF4/Heparin Total Antibodies Anti‐PF4/Heparin Total Antibodies Detection Method Absorbance (Turbimetric) Absorbance (Colorimetric) Intended Use HemosIL HIT-Ab(PF4-H) is a qualitative, fully automated, latex enhanced immunoassay for the detection of anti-platelet factor 4/heparin (PF4/H) antibodies. The assay is for use in human 3.2% or 3.8% citrated plasma on the ACL TOP® Family of instruments in a laboratory setting. The result provided by the assay should be interpreted as either positive or negative based on the assay cut-off (1.0 U/mL). The positive or negative result aids in determining the risk for heparin induced thrombocytopenia (HIT) when used in conjunction with other laboratory and clinical findings. Anti-PF4/Heparin antibodies are commonly found in patients with HIT. For use in adult population suspected of HIT. Not for use in isolation to exclude HIT. HemosIL HIT-Ab(PF4-H) Controls are for the Quality Control of the HemosIL HIT-Ab(PF4-H) assay as performed on the ACL TOP Family of instruments. For prescription use. The ASSERACHROM® HPIA Test Kit is intended for use as a qualitative procedure for the detection of anti‐heparin‐platelet factor 4 (anti-Heparin-PF4) antibodies in citrated plasma or serum by the sandwich technique of enzyme-linked immunosorbent assay (ELISA). The presence in plasma or serum of anti-Heparin-PF4 antibodies, together with a concurrent drop in platelet count, is generally associated with Type II heparin‐induced thrombocytopenia (Type II HIT), a condition that occurs during heparin therapy, leading to arterial or venous thrombosis. Assay Type Qualitative Qualitative Differences Item Device Predicate Sample Types Citrated human plasma only Citrated human plasma or serum Cut‐off Fixed clinical cut‐off: ≥ 1.0 U/mL Variable clinical cut‐off Cut‐off is lot and plate dependent. Every time a plate is processed, the cut‐off for this plate is calculated as the percentage (X%) of the value 5 Differences Item Device Predicate obtained for the reagent supplied with the kit. This percentage is provided for each lot through the insert sheets. Methodology Latex‐enhanced immuno-turbidimetric assay Two‐step enzyme immunoassay (EIA) sandwich method with a final colorimetric detection. Antibodies Purified mouse monoclonal anti-PF4-Heparin Goat anti-human antibodies to IgG, IgA and IgM Controls Controls sold separately: - Low Level at or below the cut-off - High Level at abnormal anti-PF4/H antibody level. Controls included in test kit: - Negative level - Positive level Calibrator Traceability The reported values for the kit calibrator are determined over multiple runs on the ACL TOP Family of instruments using specific lots of reagents and against an internal House Standard. Since an HIT International Standard is not currently available, arbitrary units (U/mL) have been established. Not Applicable K. Standard/Guidance Document Referenced (if applicable): EP05-A3; Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline; 2014 EP06-A; Evaluation of the Linearity of Quantitative Measurement Procedures; a Statistical Approach; Approved Guideline; 2003 EP07-A2; Interference Testing in Clinical Chemistry; Approved Guideline; 2005 EP09-A3; Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline; 2013 EP12-A2; User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline; 2008 EP14-A3; Evaluation of Commutability of Processed Samples; Approved Guideline; 2013 EP17-A2; Evaluation of Detection Capability For Clinical Laboratory Measurement Procedures; Approved Guideline; 2012 EP24-A2; Assessment of Diagnostic Accuracy of Laboratory Tests Using receiver Operating 6 Characteristic Curves; Approved Guideline; 2011 EP25-A3; Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline; 2009 EP28-A3C; Defining, Establishing and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline; 2010 L. Test Principle: The HemosIL HIT-Ab(PF4-H) kit is a latex particle enhanced immuno-turbidimetric assay to detect total Anti‐PF4/Heparin (PF4/H) antibodies found in HIT patients. A monoclonal antibody that mimics human HIT antibodies Classification:
idK153137_s0_e2000	K153137.txt	panel	Hematology (81)	k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K153137 B. Purpose for Submission: Clearance of a new device C. Measurand: Anti-PF4/Heparin Total Antibodies D. Type of Test: Automated, latex enhanced immuno-turbidimetric assay E. Applicant: Instrumentation Laboratory (IL) Co. F. Proprietary and Established Names: HemosIL HIT‐Ab(PF4‐H) HemosIL HIT‐Ab(PF4‐H) Controls G. Regulatory Information: 1. Regulation section: 21 CFR 864.7695, Platelet factor 4 radioimmunoassay 21 CFR 864.5425, Multipurpose system for in vitro coagulation studies 2. Classification: Class II 3. Product code: 2 LCO, Platelet factor 4 radioimmunoassay GGN, Plasma, Coagulation Control 4. Panel: Hematology (81) H. Intended Use: 1. Intended use(s): HemosIL HIT-Ab(PF4-H) is a qualitative, fully automated, latex enhanced immunoassay for the detection of anti-platelet factor 4/heparin (PF4/H) antibodies. The assay is for use in human 3.2% or 3.8% citrated plasma on the ACL TOP® Family of instruments in a laboratory setting. The result provided by the assay should be interpreted as either positive or negative based on the assay cut-off (1.0 U/mL). The positive or negative result aids in determining the risk for heparin induced thrombocytopenia (HIT) when used in conjunction with other laboratory and clinical findings. Anti-PF4/Heparin antibodies are commonly found in patients with HIT. For use in adult population suspected of HIT. Not for use in isolation to exclude HIT. HemoslL HIT-Ab(PF4-H) Controls are for the Quality Control of the HemosIL HIT-Ab(PF4- H) assay as performed on the ACL TOP® Family of instruments. For prescription use. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use 4. Special instrument requirements: ACL TOP® Family Instruments I. Device Description: The HemosIL HIT-Ab(PF4-H) kit is a latex particle enhanced immuno-turbidimetric assay to detect total anti‐PF4/Heparin antibodies found in HIT patients. A monoclonal 3 antibody that mimics human HIT antibodies is coated onto latex particles. The HemosIL HIT-Ab(PF4-H) kit consists of: Latex Reagent: Suspension of polystyrene latex particles coated with purified mouse monoclonal anti-PF4-Heparin in Tris buffer, containing bovine serum albumin, stabilizers and preservative. Stabilizer: PBS buffer containing bovine serum albumin, stabilizers and preservative. Complex: Solution of PF4-PVS complex (PF4 from human platelets complexed to PVS), in PBS buffer containing bovine serum albumin, stabilizers and preservative. Contains 0.02% Bronidox™ as a preservative. Calibrator: Lyophilized solution of a monoclonal anti- PF4-Heparin antibody in Tris buffer containing bovine serum albumin, stabilizers and preservative. Controls: The Low and High HIT‐Ab(PF4‐H) Controls are prepared by means of a dedicated process and contain different concentrations of humanized monoclonal anti‐PF4‐Heparin human IgG. • Low HIT Control: Control intended for the assessment of precision and accuracy of the assay at PF4/H antibody levels at or below the cut‐off. • High HIT Control: Control intended for the assessment of precision and accuracy of the assay at abnormal PF4/H antibody levels. J. Substantial Equivalence Information: 1. Predicate device name(s): Asserachrom HPIA Test kit from Diagnostica Stago 2. Predicate 510(k) number(s): K003767 3. Comparison with predicate: 4 Similarities Item Device Predicate Trade Names HemosIL HIT-Ab(PF4-H) HemosIL HIT-Ab(PF4-H) Controls (K153137) Asserachrom HPIA Test Kit (kit includes two control levels) (K003767) Measurand Anti-PF4/Heparin Total Antibodies Anti‐PF4/Heparin Total Antibodies Detection Method Absorbance (Turbimetric) Absorbance (Colorimetric) Intended Use HemosIL HIT-Ab(PF4-H) is a qualitative, fully automated, latex enhanced immunoassay for the detection of anti-platelet factor 4/heparin (PF4/H) antibodies. The assay is for use in human 3.2% or 3.8% citrated plasma on the ACL TOP® Family of instruments in a laboratory setting. The result provided by the assay should be interpreted as either positive or negative based on the assay cut-off (1.0 U/mL). The positive or negative result aids in determining the risk for heparin induced thrombocytopenia (HIT) when used in conjunction with other laboratory and clinical findings. Anti-PF4/Heparin antibodies are commonly found in patients with HIT. For use in adult population suspected of HIT. Not for use in isolation to exclude HIT. HemosIL HIT-Ab(PF4-H) Controls are for the Quality Control of the HemosIL HIT-Ab(PF4-H) assay as performed on the ACL TOP Family of instruments. For prescription use. The ASSERACHROM® HPIA Test Kit is intended for use as a qualitative procedure for the detection of anti‐heparin‐platelet factor 4 (anti-Heparin-PF4) antibodies in citrated plasma or serum by the sandwich technique of enzyme-linked immunosorbent assay (ELISA). The presence in plasma or serum of anti-Heparin-PF4 antibodies, together with a concurrent drop in platelet count, is generally associated with Type II heparin‐induced thrombocytopenia (Type II HIT), a condition that occurs during heparin therapy, leading to arterial or venous thrombosis. Assay Type Qualitative Qualitative Differences Item Device Predicate Sample Types Citrated human plasma only Citrated human plasma or serum Cut‐off Fixed clinical cut‐off: ≥ 1.0 U/mL Variable clinical cut‐off Cut‐off is lot and plate dependent. Every time a plate is processed, the cut‐off for this plate is calculated as the percentage (X%) of the value 5 Differences Item Device Predicate obtained for the reagent supplied with the kit. This percentage is provided for each lot through the insert sheets. Methodology Latex‐enhanced immuno-turbidimetric assay Two‐step enzyme immunoassay (EIA) sandwich method with a final colorimetric detection. Antibodies Purified mouse monoclonal anti-PF4-Heparin Goat anti-human antibodies to IgG, IgA and IgM Controls Controls sold separately: - Low Level at or below the cut-off - High Level at abnormal anti-PF4/H antibody level. Controls included in test kit: - Negative level - Positive level Calibrator Traceability The reported values for the kit calibrator are determined over multiple runs on the ACL TOP Family of instruments using specific lots of reagents and against an internal House Standard. Since an HIT International Standard is not currently available, arbitrary units (U/mL) have been established. Not Applicable K. Standard/Guidance Document Referenced (if applicable): EP05-A3; Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline; 2014 EP06-A; Evaluation of the Linearity of Quantitative Measurement Procedures; a Statistical Approach; Approved Guideline; 2003 EP07-A2; Interference Testing in Clinical Chemistry; Approved Guideline; 2005 EP09-A3; Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline; 2013 EP12-A2; User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline; 2008 EP14-A3; Evaluation of Commutability of Processed Samples; Approved Guideline; 2013 EP17-A2; Evaluation of Detection Capability For Clinical Laboratory Measurement Procedures; Approved Guideline; 2012 EP24-A2; Assessment of Diagnostic Accuracy of Laboratory Tests Using receiver Operating 6 Characteristic Curves; Approved Guideline; 2011 EP25-A3; Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline; 2009 EP28-A3C; Defining, Establishing and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline; 2010 L. Test Principle: The HemosIL HIT-Ab(PF4-H) kit is a latex particle enhanced immuno-turbidimetric assay to detect total Anti‐PF4/Heparin (PF4/H) antibodies found in HIT patients. A monoclonal antibody that mimics human HIT antibodies Panel:
idK153137_s0_e2000	K153137.txt	predicate device name	Asserachrom HPIA Test kit from Diagnostica Stago	STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K153137 B. Purpose for Submission: Clearance of a new device C. Measurand: Anti-PF4/Heparin Total Antibodies D. Type of Test: Automated, latex enhanced immuno-turbidimetric assay E. Applicant: Instrumentation Laboratory (IL) Co. F. Proprietary and Established Names: HemosIL HIT‐Ab(PF4‐H) HemosIL HIT‐Ab(PF4‐H) Controls G. Regulatory Information: 1. Regulation section: 21 CFR 864.7695, Platelet factor 4 radioimmunoassay 21 CFR 864.5425, Multipurpose system for in vitro coagulation studies 2. Classification: Class II 3. Product code: 2 LCO, Platelet factor 4 radioimmunoassay GGN, Plasma, Coagulation Control 4. Panel: Hematology (81) H. Intended Use: 1. Intended use(s): HemosIL HIT-Ab(PF4-H) is a qualitative, fully automated, latex enhanced immunoassay for the detection of anti-platelet factor 4/heparin (PF4/H) antibodies. The assay is for use in human 3.2% or 3.8% citrated plasma on the ACL TOP® Family of instruments in a laboratory setting. The result provided by the assay should be interpreted as either positive or negative based on the assay cut-off (1.0 U/mL). The positive or negative result aids in determining the risk for heparin induced thrombocytopenia (HIT) when used in conjunction with other laboratory and clinical findings. Anti-PF4/Heparin antibodies are commonly found in patients with HIT. For use in adult population suspected of HIT. Not for use in isolation to exclude HIT. HemoslL HIT-Ab(PF4-H) Controls are for the Quality Control of the HemosIL HIT-Ab(PF4- H) assay as performed on the ACL TOP® Family of instruments. For prescription use. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use 4. Special instrument requirements: ACL TOP® Family Instruments I. Device Description: The HemosIL HIT-Ab(PF4-H) kit is a latex particle enhanced immuno-turbidimetric assay to detect total anti‐PF4/Heparin antibodies found in HIT patients. A monoclonal 3 antibody that mimics human HIT antibodies is coated onto latex particles. The HemosIL HIT-Ab(PF4-H) kit consists of: Latex Reagent: Suspension of polystyrene latex particles coated with purified mouse monoclonal anti-PF4-Heparin in Tris buffer, containing bovine serum albumin, stabilizers and preservative. Stabilizer: PBS buffer containing bovine serum albumin, stabilizers and preservative. Complex: Solution of PF4-PVS complex (PF4 from human platelets complexed to PVS), in PBS buffer containing bovine serum albumin, stabilizers and preservative. Contains 0.02% Bronidox™ as a preservative. Calibrator: Lyophilized solution of a monoclonal anti- PF4-Heparin antibody in Tris buffer containing bovine serum albumin, stabilizers and preservative. Controls: The Low and High HIT‐Ab(PF4‐H) Controls are prepared by means of a dedicated process and contain different concentrations of humanized monoclonal anti‐PF4‐Heparin human IgG. • Low HIT Control: Control intended for the assessment of precision and accuracy of the assay at PF4/H antibody levels at or below the cut‐off. • High HIT Control: Control intended for the assessment of precision and accuracy of the assay at abnormal PF4/H antibody levels. J. Substantial Equivalence Information: 1. Predicate device name(s): Asserachrom HPIA Test kit from Diagnostica Stago 2. Predicate 510(k) number(s): K003767 3. Comparison with predicate: 4 Similarities Item Device Predicate Trade Names HemosIL HIT-Ab(PF4-H) HemosIL HIT-Ab(PF4-H) Controls (K153137) Asserachrom HPIA Test Kit (kit includes two control levels) (K003767) Measurand Anti-PF4/Heparin Total Antibodies Anti‐PF4/Heparin Total Antibodies Detection Method Absorbance (Turbimetric) Absorbance (Colorimetric) Intended Use HemosIL HIT-Ab(PF4-H) is a qualitative, fully automated, latex enhanced immunoassay for the detection of anti-platelet factor 4/heparin (PF4/H) antibodies. The assay is for use in human 3.2% or 3.8% citrated plasma on the ACL TOP® Family of instruments in a laboratory setting. The result provided by the assay should be interpreted as either positive or negative based on the assay cut-off (1.0 U/mL). The positive or negative result aids in determining the risk for heparin induced thrombocytopenia (HIT) when used in conjunction with other laboratory and clinical findings. Anti-PF4/Heparin antibodies are commonly found in patients with HIT. For use in adult population suspected of HIT. Not for use in isolation to exclude HIT. HemosIL HIT-Ab(PF4-H) Controls are for the Quality Control of the HemosIL HIT-Ab(PF4-H) assay as performed on the ACL TOP Family of instruments. For prescription use. The ASSERACHROM® HPIA Test Kit is intended for use as a qualitative procedure for the detection of anti‐heparin‐platelet factor 4 (anti-Heparin-PF4) antibodies in citrated plasma or serum by the sandwich technique of enzyme-linked immunosorbent assay (ELISA). The presence in plasma or serum of anti-Heparin-PF4 antibodies, together with a concurrent drop in platelet count, is generally associated with Type II heparin‐induced thrombocytopenia (Type II HIT), a condition that occurs during heparin therapy, leading to arterial or venous thrombosis. Assay Type Qualitative Qualitative Differences Item Device Predicate Sample Types Citrated human plasma only Citrated human plasma or serum Cut‐off Fixed clinical cut‐off: ≥ 1.0 U/mL Variable clinical cut‐off Cut‐off is lot and plate dependent. Every time a plate is processed, the cut‐off for this plate is calculated as the percentage (X%) of the value 5 Differences Item Device Predicate obtained for the reagent supplied with the kit. This percentage is provided for each lot through the insert sheets. Methodology Latex‐enhanced immuno-turbidimetric assay Two‐step enzyme immunoassay (EIA) sandwich method with a final colorimetric detection. Antibodies Purified mouse monoclonal anti-PF4-Heparin Goat anti-human antibodies to IgG, IgA and IgM Controls Controls sold separately: - Low Level at or below the cut-off - High Level at abnormal anti-PF4/H antibody level. Controls included in test kit: - Negative level - Positive level Calibrator Traceability The reported values for the kit calibrator are determined over multiple runs on the ACL TOP Family of instruments using specific lots of reagents and against an internal House Standard. Since an HIT International Standard is not currently available, arbitrary units (U/mL) have been established. Not Applicable K. Standard/Guidance Document Referenced (if applicable): EP05-A3; Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline; 2014 EP06-A; Evaluation of the Linearity of Quantitative Measurement Procedures; a Statistical Approach; Approved Guideline; 2003 EP07-A2; Interference Testing in Clinical Chemistry; Approved Guideline; 2005 EP09-A3; Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline; 2013 EP12-A2; User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline; 2008 EP14-A3; Evaluation of Commutability of Processed Samples; Approved Guideline; 2013 EP17-A2; Evaluation of Detection Capability For Clinical Laboratory Measurement Procedures; Approved Guideline; 2012 EP24-A2; Assessment of Diagnostic Accuracy of Laboratory Tests Using receiver Operating 6 Characteristic Curves; Approved Guideline; 2011 EP25-A3; Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline; 2009 EP28-A3C; Defining, Establishing and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline; 2010 L. Test Principle: The HemosIL HIT-Ab(PF4-H) kit is a latex particle enhanced immuno-turbidimetric assay to detect total Anti‐PF4/Heparin (PF4/H) antibodies found in HIT patients. A monoclonal antibody that mimics human HIT antibodies Predicate device name:
idK153137_s0_e2000	K153137.txt	applicant	Instrumentation Laboratory (IL) Co.	) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K153137 B. Purpose for Submission: Clearance of a new device C. Measurand: Anti-PF4/Heparin Total Antibodies D. Type of Test: Automated, latex enhanced immuno-turbidimetric assay E. Applicant: Instrumentation Laboratory (IL) Co. F. Proprietary and Established Names: HemosIL HIT‐Ab(PF4‐H) HemosIL HIT‐Ab(PF4‐H) Controls G. Regulatory Information: 1. Regulation section: 21 CFR 864.7695, Platelet factor 4 radioimmunoassay 21 CFR 864.5425, Multipurpose system for in vitro coagulation studies 2. Classification: Class II 3. Product code: 2 LCO, Platelet factor 4 radioimmunoassay GGN, Plasma, Coagulation Control 4. Panel: Hematology (81) H. Intended Use: 1. Intended use(s): HemosIL HIT-Ab(PF4-H) is a qualitative, fully automated, latex enhanced immunoassay for the detection of anti-platelet factor 4/heparin (PF4/H) antibodies. The assay is for use in human 3.2% or 3.8% citrated plasma on the ACL TOP® Family of instruments in a laboratory setting. The result provided by the assay should be interpreted as either positive or negative based on the assay cut-off (1.0 U/mL). The positive or negative result aids in determining the risk for heparin induced thrombocytopenia (HIT) when used in conjunction with other laboratory and clinical findings. Anti-PF4/Heparin antibodies are commonly found in patients with HIT. For use in adult population suspected of HIT. Not for use in isolation to exclude HIT. HemoslL HIT-Ab(PF4-H) Controls are for the Quality Control of the HemosIL HIT-Ab(PF4- H) assay as performed on the ACL TOP® Family of instruments. For prescription use. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use 4. Special instrument requirements: ACL TOP® Family Instruments I. Device Description: The HemosIL HIT-Ab(PF4-H) kit is a latex particle enhanced immuno-turbidimetric assay to detect total anti‐PF4/Heparin antibodies found in HIT patients. A monoclonal 3 antibody that mimics human HIT antibodies is coated onto latex particles. The HemosIL HIT-Ab(PF4-H) kit consists of: Latex Reagent: Suspension of polystyrene latex particles coated with purified mouse monoclonal anti-PF4-Heparin in Tris buffer, containing bovine serum albumin, stabilizers and preservative. Stabilizer: PBS buffer containing bovine serum albumin, stabilizers and preservative. Complex: Solution of PF4-PVS complex (PF4 from human platelets complexed to PVS), in PBS buffer containing bovine serum albumin, stabilizers and preservative. Contains 0.02% Bronidox™ as a preservative. Calibrator: Lyophilized solution of a monoclonal anti- PF4-Heparin antibody in Tris buffer containing bovine serum albumin, stabilizers and preservative. Controls: The Low and High HIT‐Ab(PF4‐H) Controls are prepared by means of a dedicated process and contain different concentrations of humanized monoclonal anti‐PF4‐Heparin human IgG. • Low HIT Control: Control intended for the assessment of precision and accuracy of the assay at PF4/H antibody levels at or below the cut‐off. • High HIT Control: Control intended for the assessment of precision and accuracy of the assay at abnormal PF4/H antibody levels. J. Substantial Equivalence Information: 1. Predicate device name(s): Asserachrom HPIA Test kit from Diagnostica Stago 2. Predicate 510(k) number(s): K003767 3. Comparison with predicate: 4 Similarities Item Device Predicate Trade Names HemosIL HIT-Ab(PF4-H) HemosIL HIT-Ab(PF4-H) Controls (K153137) Asserachrom HPIA Test Kit (kit includes two control levels) (K003767) Measurand Anti-PF4/Heparin Total Antibodies Anti‐PF4/Heparin Total Antibodies Detection Method Absorbance (Turbimetric) Absorbance (Colorimetric) Intended Use HemosIL HIT-Ab(PF4-H) is a qualitative, fully automated, latex enhanced immunoassay for the detection of anti-platelet factor 4/heparin (PF4/H) antibodies. The assay is for use in human 3.2% or 3.8% citrated plasma on the ACL TOP® Family of instruments in a laboratory setting. The result provided by the assay should be interpreted as either positive or negative based on the assay cut-off (1.0 U/mL). The positive or negative result aids in determining the risk for heparin induced thrombocytopenia (HIT) when used in conjunction with other laboratory and clinical findings. Anti-PF4/Heparin antibodies are commonly found in patients with HIT. For use in adult population suspected of HIT. Not for use in isolation to exclude HIT. HemosIL HIT-Ab(PF4-H) Controls are for the Quality Control of the HemosIL HIT-Ab(PF4-H) assay as performed on the ACL TOP Family of instruments. For prescription use. The ASSERACHROM® HPIA Test Kit is intended for use as a qualitative procedure for the detection of anti‐heparin‐platelet factor 4 (anti-Heparin-PF4) antibodies in citrated plasma or serum by the sandwich technique of enzyme-linked immunosorbent assay (ELISA). The presence in plasma or serum of anti-Heparin-PF4 antibodies, together with a concurrent drop in platelet count, is generally associated with Type II heparin‐induced thrombocytopenia (Type II HIT), a condition that occurs during heparin therapy, leading to arterial or venous thrombosis. Assay Type Qualitative Qualitative Differences Item Device Predicate Sample Types Citrated human plasma only Citrated human plasma or serum Cut‐off Fixed clinical cut‐off: ≥ 1.0 U/mL Variable clinical cut‐off Cut‐off is lot and plate dependent. Every time a plate is processed, the cut‐off for this plate is calculated as the percentage (X%) of the value 5 Differences Item Device Predicate obtained for the reagent supplied with the kit. This percentage is provided for each lot through the insert sheets. Methodology Latex‐enhanced immuno-turbidimetric assay Two‐step enzyme immunoassay (EIA) sandwich method with a final colorimetric detection. Antibodies Purified mouse monoclonal anti-PF4-Heparin Goat anti-human antibodies to IgG, IgA and IgM Controls Controls sold separately: - Low Level at or below the cut-off - High Level at abnormal anti-PF4/H antibody level. Controls included in test kit: - Negative level - Positive level Calibrator Traceability The reported values for the kit calibrator are determined over multiple runs on the ACL TOP Family of instruments using specific lots of reagents and against an internal House Standard. Since an HIT International Standard is not currently available, arbitrary units (U/mL) have been established. Not Applicable K. Standard/Guidance Document Referenced (if applicable): EP05-A3; Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline; 2014 EP06-A; Evaluation of the Linearity of Quantitative Measurement Procedures; a Statistical Approach; Approved Guideline; 2003 EP07-A2; Interference Testing in Clinical Chemistry; Approved Guideline; 2005 EP09-A3; Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline; 2013 EP12-A2; User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline; 2008 EP14-A3; Evaluation of Commutability of Processed Samples; Approved Guideline; 2013 EP17-A2; Evaluation of Detection Capability For Clinical Laboratory Measurement Procedures; Approved Guideline; 2012 EP24-A2; Assessment of Diagnostic Accuracy of Laboratory Tests Using receiver Operating 6 Characteristic Curves; Approved Guideline; 2011 EP25-A3; Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline; 2009 EP28-A3C; Defining, Establishing and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline; 2010 L. Test Principle: The HemosIL HIT-Ab(PF4-H) kit is a latex particle enhanced immuno-turbidimetric assay to detect total Anti‐PF4/Heparin (PF4/H) antibodies found in HIT patients. A monoclonal antibody that mimics human HIT antibodies Applicant:
idK153137_s8000_e10000	K153137.txt	proposed labeling	The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.	: Bar code; manual entry 4. Specimen Sampling and Handling: Automated 5. Calibration: Automated, the calibrator is a component of the assay kit. 6. Quality Control: Two levels of control are recommended for a complete quality control program. HemosIL HIT-Ab(PF4-H) Controls Low and High are designed for this program. Each laboratory should establish its own mean and standard deviation, and should establish a quality control program to monitor laboratory testing. Controls should be analyzed at least once every 8 hour shift, in accordance with good laboratory practice. Refer to the instrument’s Operator’s Manual for additional information. P. Other Supportive Instrument Performance Characteristics Data Not Covered In The “Performance Characteristics” Section above: Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Proposed labeling:
idK153137_s8000_e10000	K153137.txt	conclusion	The submitted information in this premarket notification is complete and supports a substantial equivalence decision.	imen Identification: Bar code; manual entry 4. Specimen Sampling and Handling: Automated 5. Calibration: Automated, the calibrator is a component of the assay kit. 6. Quality Control: Two levels of control are recommended for a complete quality control program. HemosIL HIT-Ab(PF4-H) Controls Low and High are designed for this program. Each laboratory should establish its own mean and standard deviation, and should establish a quality control program to monitor laboratory testing. Controls should be analyzed at least once every 8 hour shift, in accordance with good laboratory practice. Refer to the instrument’s Operator’s Manual for additional information. P. Other Supportive Instrument Performance Characteristics Data Not Covered In The “Performance Characteristics” Section above: Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Conclusion:
idK150041_s0_e2000	K150041.txt	purpose for submission	Clearance of a new device	STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K150041 B. Purpose for Submission: Clearance of a new device C. Measurand: Coagulation factors (intrinsic and extrinsic pathway) and platelet aggregation D. Type of Test: Whole blood hemostasis E. Applicant: Coramed Technologies, LLC F. Proprietary and Established Names: CORA® (Coagulation Resonance Analysis) System The system includes the CORA instrument and the following reagents: CK (Citrated Kaolin), CRT (Citrated RapidTEG), CKH (Citrated Kaolin with Heparinase), and CFF (Citrated Functional Fibrinogen). G. Regulatory Information: 1. Regulation section: 21 CFR 864.5425, Multipurpose system for in vitro coagulation studies 21 CFR 864.5700, Automated platelet aggregation system 2. Classification: Class II 3. Product code: 2 JPA, System, Multipurpose For In Vitro Coagulation Control GGN, Plasma, Coagulation Control 4. Panel: Hematology (81) H. Intended Use: 1. Intended use(s): CORA Hemostasis System: The CORA System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a blood sample. The CORA System records the kinetic changes in a venous sample of 3.2% citrated whole blood as the sample clots, and retracts in real time. The system output consists of a table of numerical values for parameters R, K, Angle, MA, and FLEV. The CORA System provides specific blood modifiers, in the form of reagents dried-in-place within CORA Cartridges. Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient's medical history, the clinical picture and, if necessary, further hemostasis tests. Citrated Multichannel Cartridge: The CORA System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a venous blood sample. The citrated Multichannel Cartridge, to be used with the CORA System instrument, contains four independent assays (CK, CRT, CKH and CFF), described below. The CK assay monitors the hemostasis process via the intrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameters Clotting Time (R), Speed of Clot Formation (K and Alpha angle) and Maximum Clot Strength (MA). The CRT assay monitors the hemostasis process via both the intrinsic and extrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameter Maximum Clot Strength (MA). The CRT MA parameter is equivalent to the CK MA parameter but the final MA value is reached more quickly using the CRT assay. The CKH assay monitors the effects of heparin in 3.2% citrated whole blood specimens on the CORA System. CKH is used in conjunction with CK, and heparin influence is 3 determined by comparing Clotting Times (R) between the two tests. The CFF assay monitors hemostasis of 3.2% citrated whole blood specimens in the CORA System after blocking platelet contribution to clot strength. Clotting characteristics are described by the functional parameters Maximum Clot Strength (MA) and the Estimated Functional Fibrinogen Level (FLEV). Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient’s medical history, the clinical picture and, if necessary, further hemostasis tests. Abnormal Wet Quality Control (WQC) Material: The CORA System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a venous blood sample. The Abnormal Wet Quality Control Material is to be used for monitoring the accuracy and precision of tests carried out on the CORA System. Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient’s medical history, the clinical picture and, if necessary, further hemostasis tests. 2. Indication(s) for use: The indication for CORA System use is with adult patients where an evaluation of their blood hemostasis properties is desired. Hemostasis evaluations are commonly used to assess clinical conditions in cardiovascular surgery and cardiology procedures to assess hemorrhage or thrombosis conditions before, during and following the procedure. 3. Special conditions for use statement(s): Prescription Use Only 4. Special instrument requirements: For use with the CORA® (Coagulation Resonance Analysis) Instrument I. Device Description: The CORA System consists of a four-channel diagnostic analyzer with integrated computer module, system reagents, and Abnormal Quality Control material and microfluidic test cartridges. The reagents included in the cartridge consist of: 1) Citrated Kaolin (CK); where the hemostasis process via the intrinsic pathway is measured, and clotting characteristics are described by the functional parameters Clotting Time (R), Speed of Clot Formation (K and Alpha angle), and Maximum Clot Strength (MA), 2) Citrated RapidTEG (CRT); where the 4 hemostasis process via both the intrinsic and extrinsic pathway is measured, and clotting characteristics are described by the functional parameter Maximum Clot Strength (MA), 3) Citrated Functional Fibrinogen (CFF); where the hemostasis process, in conjunction with the CK reagent, is monitored after blocking platelet contributions to clot strength, and clotting characteristics are described by the functional parameter Maximum Clot Strength (MA) and the Estimated Functional Fibrinogen Level (FLEV), 4) Citrated Kaolin Heparinase (CKH); where the effects of heparin in the blood stream, in conjunction with the CKH reagent, and heparin influence is determined by comparing Clotting Times (R) between the two tests. Reagents are dried-in-place within the cartridges during manufacturing. Abnormal Quality Control material is lyophilized and can be reconstituted with water as needed for WQC testing with reagent cartridges. J. Substantial Equivalence Information: 1. Predicate device name(s): Thromboelastograph® Coagualtion Analyzer (TEG)-5000 Series, Haemoscope Corporation 2. Predicate 510(k) number(s): K002177 3. Comparison with predicate: Similarities Item CORA System TEG 5000 Predicate Intended Use The CORA System is intended for in vitro diagnostic use to provide semi- quantitative indications of the hemostasis state of a blood sample. The CORA System records the kinetic changes in a venous sample of 3.2% citrated whole blood as the sample clots, and retracts in real time. The system output consists of a table of numerical values for parameters R, K, Angle, MA, and FLEV. The CORA System provides specific blood modifiers, in the form of reagents dried-in-place within CORA Cartridges. Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient's The TEG 5000 Series Analyzer is intended to be used to provide a quantitative and qualitative indication of the coagulation state of a blood sample by monitoring, measuring, analyzing and reporting coagulation parameter information. The Thrombelastograph (TEG) Coagulation Analyzer TEG-5000 Series records the kinetic changes in a sample of whole blood, plasma or platelet-rich-plasma as the sample clots, retracts and./or lyses (breaks apart). Results from the TEG Analyzer should not be the sole basis for a patient diagnosis; TEG results should be considered along with a 5 Similarities Item CORA System TEG 5000 Predicate medical history, the clinical picture and, if necessary, further hemostasis tests. The CORA System is intended for in vitro diagnostic use to provide semi- quantitative indications of the hemostasis state of a venous blood sample. The citrated Multichannel Cartridge, to be used with the CORA System instrument, contains four independent assays (CK, CRT, CKH and CFF), described below. The CK assay monitors the hemostasis process via the intrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameters Clotting Time (R), Speed of Clot Formation (K and Alpha angle) and Maximum Clot Strength (MA). The CRT assay monitors the hemostasis process via both the intrinsic and extrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameter Maximum Clot Strength (MA). The CRT MA parameter is equivalent to the CK MA parameter but the final MA value is reached more quickly using the CRT assay. The CKH assay monitors the effects of heparin in 3.2% citrated whole blood specimens on the CORA System Purpose for submission:
idK150041_s0_e2000	K150041.txt	measurand	Coagulation factors (intrinsic and extrinsic pathway) and platelet aggregation	STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K150041 B. Purpose for Submission: Clearance of a new device C. Measurand: Coagulation factors (intrinsic and extrinsic pathway) and platelet aggregation D. Type of Test: Whole blood hemostasis E. Applicant: Coramed Technologies, LLC F. Proprietary and Established Names: CORA® (Coagulation Resonance Analysis) System The system includes the CORA instrument and the following reagents: CK (Citrated Kaolin), CRT (Citrated RapidTEG), CKH (Citrated Kaolin with Heparinase), and CFF (Citrated Functional Fibrinogen). G. Regulatory Information: 1. Regulation section: 21 CFR 864.5425, Multipurpose system for in vitro coagulation studies 21 CFR 864.5700, Automated platelet aggregation system 2. Classification: Class II 3. Product code: 2 JPA, System, Multipurpose For In Vitro Coagulation Control GGN, Plasma, Coagulation Control 4. Panel: Hematology (81) H. Intended Use: 1. Intended use(s): CORA Hemostasis System: The CORA System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a blood sample. The CORA System records the kinetic changes in a venous sample of 3.2% citrated whole blood as the sample clots, and retracts in real time. The system output consists of a table of numerical values for parameters R, K, Angle, MA, and FLEV. The CORA System provides specific blood modifiers, in the form of reagents dried-in-place within CORA Cartridges. Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient's medical history, the clinical picture and, if necessary, further hemostasis tests. Citrated Multichannel Cartridge: The CORA System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a venous blood sample. The citrated Multichannel Cartridge, to be used with the CORA System instrument, contains four independent assays (CK, CRT, CKH and CFF), described below. The CK assay monitors the hemostasis process via the intrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameters Clotting Time (R), Speed of Clot Formation (K and Alpha angle) and Maximum Clot Strength (MA). The CRT assay monitors the hemostasis process via both the intrinsic and extrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameter Maximum Clot Strength (MA). The CRT MA parameter is equivalent to the CK MA parameter but the final MA value is reached more quickly using the CRT assay. The CKH assay monitors the effects of heparin in 3.2% citrated whole blood specimens on the CORA System. CKH is used in conjunction with CK, and heparin influence is 3 determined by comparing Clotting Times (R) between the two tests. The CFF assay monitors hemostasis of 3.2% citrated whole blood specimens in the CORA System after blocking platelet contribution to clot strength. Clotting characteristics are described by the functional parameters Maximum Clot Strength (MA) and the Estimated Functional Fibrinogen Level (FLEV). Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient’s medical history, the clinical picture and, if necessary, further hemostasis tests. Abnormal Wet Quality Control (WQC) Material: The CORA System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a venous blood sample. The Abnormal Wet Quality Control Material is to be used for monitoring the accuracy and precision of tests carried out on the CORA System. Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient’s medical history, the clinical picture and, if necessary, further hemostasis tests. 2. Indication(s) for use: The indication for CORA System use is with adult patients where an evaluation of their blood hemostasis properties is desired. Hemostasis evaluations are commonly used to assess clinical conditions in cardiovascular surgery and cardiology procedures to assess hemorrhage or thrombosis conditions before, during and following the procedure. 3. Special conditions for use statement(s): Prescription Use Only 4. Special instrument requirements: For use with the CORA® (Coagulation Resonance Analysis) Instrument I. Device Description: The CORA System consists of a four-channel diagnostic analyzer with integrated computer module, system reagents, and Abnormal Quality Control material and microfluidic test cartridges. The reagents included in the cartridge consist of: 1) Citrated Kaolin (CK); where the hemostasis process via the intrinsic pathway is measured, and clotting characteristics are described by the functional parameters Clotting Time (R), Speed of Clot Formation (K and Alpha angle), and Maximum Clot Strength (MA), 2) Citrated RapidTEG (CRT); where the 4 hemostasis process via both the intrinsic and extrinsic pathway is measured, and clotting characteristics are described by the functional parameter Maximum Clot Strength (MA), 3) Citrated Functional Fibrinogen (CFF); where the hemostasis process, in conjunction with the CK reagent, is monitored after blocking platelet contributions to clot strength, and clotting characteristics are described by the functional parameter Maximum Clot Strength (MA) and the Estimated Functional Fibrinogen Level (FLEV), 4) Citrated Kaolin Heparinase (CKH); where the effects of heparin in the blood stream, in conjunction with the CKH reagent, and heparin influence is determined by comparing Clotting Times (R) between the two tests. Reagents are dried-in-place within the cartridges during manufacturing. Abnormal Quality Control material is lyophilized and can be reconstituted with water as needed for WQC testing with reagent cartridges. J. Substantial Equivalence Information: 1. Predicate device name(s): Thromboelastograph® Coagualtion Analyzer (TEG)-5000 Series, Haemoscope Corporation 2. Predicate 510(k) number(s): K002177 3. Comparison with predicate: Similarities Item CORA System TEG 5000 Predicate Intended Use The CORA System is intended for in vitro diagnostic use to provide semi- quantitative indications of the hemostasis state of a blood sample. The CORA System records the kinetic changes in a venous sample of 3.2% citrated whole blood as the sample clots, and retracts in real time. The system output consists of a table of numerical values for parameters R, K, Angle, MA, and FLEV. The CORA System provides specific blood modifiers, in the form of reagents dried-in-place within CORA Cartridges. Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient's The TEG 5000 Series Analyzer is intended to be used to provide a quantitative and qualitative indication of the coagulation state of a blood sample by monitoring, measuring, analyzing and reporting coagulation parameter information. The Thrombelastograph (TEG) Coagulation Analyzer TEG-5000 Series records the kinetic changes in a sample of whole blood, plasma or platelet-rich-plasma as the sample clots, retracts and./or lyses (breaks apart). Results from the TEG Analyzer should not be the sole basis for a patient diagnosis; TEG results should be considered along with a 5 Similarities Item CORA System TEG 5000 Predicate medical history, the clinical picture and, if necessary, further hemostasis tests. The CORA System is intended for in vitro diagnostic use to provide semi- quantitative indications of the hemostasis state of a venous blood sample. The citrated Multichannel Cartridge, to be used with the CORA System instrument, contains four independent assays (CK, CRT, CKH and CFF), described below. The CK assay monitors the hemostasis process via the intrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameters Clotting Time (R), Speed of Clot Formation (K and Alpha angle) and Maximum Clot Strength (MA). The CRT assay monitors the hemostasis process via both the intrinsic and extrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameter Maximum Clot Strength (MA). The CRT MA parameter is equivalent to the CK MA parameter but the final MA value is reached more quickly using the CRT assay. The CKH assay monitors the effects of heparin in 3.2% citrated whole blood specimens on the CORA System Measurand:
idK150041_s0_e2000	K150041.txt	type of test	Whole blood hemostasis	SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K150041 B. Purpose for Submission: Clearance of a new device C. Measurand: Coagulation factors (intrinsic and extrinsic pathway) and platelet aggregation D. Type of Test: Whole blood hemostasis E. Applicant: Coramed Technologies, LLC F. Proprietary and Established Names: CORA® (Coagulation Resonance Analysis) System The system includes the CORA instrument and the following reagents: CK (Citrated Kaolin), CRT (Citrated RapidTEG), CKH (Citrated Kaolin with Heparinase), and CFF (Citrated Functional Fibrinogen). G. Regulatory Information: 1. Regulation section: 21 CFR 864.5425, Multipurpose system for in vitro coagulation studies 21 CFR 864.5700, Automated platelet aggregation system 2. Classification: Class II 3. Product code: 2 JPA, System, Multipurpose For In Vitro Coagulation Control GGN, Plasma, Coagulation Control 4. Panel: Hematology (81) H. Intended Use: 1. Intended use(s): CORA Hemostasis System: The CORA System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a blood sample. The CORA System records the kinetic changes in a venous sample of 3.2% citrated whole blood as the sample clots, and retracts in real time. The system output consists of a table of numerical values for parameters R, K, Angle, MA, and FLEV. The CORA System provides specific blood modifiers, in the form of reagents dried-in-place within CORA Cartridges. Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient's medical history, the clinical picture and, if necessary, further hemostasis tests. Citrated Multichannel Cartridge: The CORA System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a venous blood sample. The citrated Multichannel Cartridge, to be used with the CORA System instrument, contains four independent assays (CK, CRT, CKH and CFF), described below. The CK assay monitors the hemostasis process via the intrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameters Clotting Time (R), Speed of Clot Formation (K and Alpha angle) and Maximum Clot Strength (MA). The CRT assay monitors the hemostasis process via both the intrinsic and extrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameter Maximum Clot Strength (MA). The CRT MA parameter is equivalent to the CK MA parameter but the final MA value is reached more quickly using the CRT assay. The CKH assay monitors the effects of heparin in 3.2% citrated whole blood specimens on the CORA System. CKH is used in conjunction with CK, and heparin influence is 3 determined by comparing Clotting Times (R) between the two tests. The CFF assay monitors hemostasis of 3.2% citrated whole blood specimens in the CORA System after blocking platelet contribution to clot strength. Clotting characteristics are described by the functional parameters Maximum Clot Strength (MA) and the Estimated Functional Fibrinogen Level (FLEV). Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient’s medical history, the clinical picture and, if necessary, further hemostasis tests. Abnormal Wet Quality Control (WQC) Material: The CORA System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a venous blood sample. The Abnormal Wet Quality Control Material is to be used for monitoring the accuracy and precision of tests carried out on the CORA System. Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient’s medical history, the clinical picture and, if necessary, further hemostasis tests. 2. Indication(s) for use: The indication for CORA System use is with adult patients where an evaluation of their blood hemostasis properties is desired. Hemostasis evaluations are commonly used to assess clinical conditions in cardiovascular surgery and cardiology procedures to assess hemorrhage or thrombosis conditions before, during and following the procedure. 3. Special conditions for use statement(s): Prescription Use Only 4. Special instrument requirements: For use with the CORA® (Coagulation Resonance Analysis) Instrument I. Device Description: The CORA System consists of a four-channel diagnostic analyzer with integrated computer module, system reagents, and Abnormal Quality Control material and microfluidic test cartridges. The reagents included in the cartridge consist of: 1) Citrated Kaolin (CK); where the hemostasis process via the intrinsic pathway is measured, and clotting characteristics are described by the functional parameters Clotting Time (R), Speed of Clot Formation (K and Alpha angle), and Maximum Clot Strength (MA), 2) Citrated RapidTEG (CRT); where the 4 hemostasis process via both the intrinsic and extrinsic pathway is measured, and clotting characteristics are described by the functional parameter Maximum Clot Strength (MA), 3) Citrated Functional Fibrinogen (CFF); where the hemostasis process, in conjunction with the CK reagent, is monitored after blocking platelet contributions to clot strength, and clotting characteristics are described by the functional parameter Maximum Clot Strength (MA) and the Estimated Functional Fibrinogen Level (FLEV), 4) Citrated Kaolin Heparinase (CKH); where the effects of heparin in the blood stream, in conjunction with the CKH reagent, and heparin influence is determined by comparing Clotting Times (R) between the two tests. Reagents are dried-in-place within the cartridges during manufacturing. Abnormal Quality Control material is lyophilized and can be reconstituted with water as needed for WQC testing with reagent cartridges. J. Substantial Equivalence Information: 1. Predicate device name(s): Thromboelastograph® Coagualtion Analyzer (TEG)-5000 Series, Haemoscope Corporation 2. Predicate 510(k) number(s): K002177 3. Comparison with predicate: Similarities Item CORA System TEG 5000 Predicate Intended Use The CORA System is intended for in vitro diagnostic use to provide semi- quantitative indications of the hemostasis state of a blood sample. The CORA System records the kinetic changes in a venous sample of 3.2% citrated whole blood as the sample clots, and retracts in real time. The system output consists of a table of numerical values for parameters R, K, Angle, MA, and FLEV. The CORA System provides specific blood modifiers, in the form of reagents dried-in-place within CORA Cartridges. Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient's The TEG 5000 Series Analyzer is intended to be used to provide a quantitative and qualitative indication of the coagulation state of a blood sample by monitoring, measuring, analyzing and reporting coagulation parameter information. The Thrombelastograph (TEG) Coagulation Analyzer TEG-5000 Series records the kinetic changes in a sample of whole blood, plasma or platelet-rich-plasma as the sample clots, retracts and./or lyses (breaks apart). Results from the TEG Analyzer should not be the sole basis for a patient diagnosis; TEG results should be considered along with a 5 Similarities Item CORA System TEG 5000 Predicate medical history, the clinical picture and, if necessary, further hemostasis tests. The CORA System is intended for in vitro diagnostic use to provide semi- quantitative indications of the hemostasis state of a venous blood sample. The citrated Multichannel Cartridge, to be used with the CORA System instrument, contains four independent assays (CK, CRT, CKH and CFF), described below. The CK assay monitors the hemostasis process via the intrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameters Clotting Time (R), Speed of Clot Formation (K and Alpha angle) and Maximum Clot Strength (MA). The CRT assay monitors the hemostasis process via both the intrinsic and extrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameter Maximum Clot Strength (MA). The CRT MA parameter is equivalent to the CK MA parameter but the final MA value is reached more quickly using the CRT assay. The CKH assay monitors the effects of heparin in 3.2% citrated whole blood specimens on the CORA System Type of test:
idK150041_s0_e2000	K150041.txt	classification	Class II	) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K150041 B. Purpose for Submission: Clearance of a new device C. Measurand: Coagulation factors (intrinsic and extrinsic pathway) and platelet aggregation D. Type of Test: Whole blood hemostasis E. Applicant: Coramed Technologies, LLC F. Proprietary and Established Names: CORA® (Coagulation Resonance Analysis) System The system includes the CORA instrument and the following reagents: CK (Citrated Kaolin), CRT (Citrated RapidTEG), CKH (Citrated Kaolin with Heparinase), and CFF (Citrated Functional Fibrinogen). G. Regulatory Information: 1. Regulation section: 21 CFR 864.5425, Multipurpose system for in vitro coagulation studies 21 CFR 864.5700, Automated platelet aggregation system 2. Classification: Class II 3. Product code: 2 JPA, System, Multipurpose For In Vitro Coagulation Control GGN, Plasma, Coagulation Control 4. Panel: Hematology (81) H. Intended Use: 1. Intended use(s): CORA Hemostasis System: The CORA System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a blood sample. The CORA System records the kinetic changes in a venous sample of 3.2% citrated whole blood as the sample clots, and retracts in real time. The system output consists of a table of numerical values for parameters R, K, Angle, MA, and FLEV. The CORA System provides specific blood modifiers, in the form of reagents dried-in-place within CORA Cartridges. Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient's medical history, the clinical picture and, if necessary, further hemostasis tests. Citrated Multichannel Cartridge: The CORA System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a venous blood sample. The citrated Multichannel Cartridge, to be used with the CORA System instrument, contains four independent assays (CK, CRT, CKH and CFF), described below. The CK assay monitors the hemostasis process via the intrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameters Clotting Time (R), Speed of Clot Formation (K and Alpha angle) and Maximum Clot Strength (MA). The CRT assay monitors the hemostasis process via both the intrinsic and extrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameter Maximum Clot Strength (MA). The CRT MA parameter is equivalent to the CK MA parameter but the final MA value is reached more quickly using the CRT assay. The CKH assay monitors the effects of heparin in 3.2% citrated whole blood specimens on the CORA System. CKH is used in conjunction with CK, and heparin influence is 3 determined by comparing Clotting Times (R) between the two tests. The CFF assay monitors hemostasis of 3.2% citrated whole blood specimens in the CORA System after blocking platelet contribution to clot strength. Clotting characteristics are described by the functional parameters Maximum Clot Strength (MA) and the Estimated Functional Fibrinogen Level (FLEV). Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient’s medical history, the clinical picture and, if necessary, further hemostasis tests. Abnormal Wet Quality Control (WQC) Material: The CORA System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a venous blood sample. The Abnormal Wet Quality Control Material is to be used for monitoring the accuracy and precision of tests carried out on the CORA System. Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient’s medical history, the clinical picture and, if necessary, further hemostasis tests. 2. Indication(s) for use: The indication for CORA System use is with adult patients where an evaluation of their blood hemostasis properties is desired. Hemostasis evaluations are commonly used to assess clinical conditions in cardiovascular surgery and cardiology procedures to assess hemorrhage or thrombosis conditions before, during and following the procedure. 3. Special conditions for use statement(s): Prescription Use Only 4. Special instrument requirements: For use with the CORA® (Coagulation Resonance Analysis) Instrument I. Device Description: The CORA System consists of a four-channel diagnostic analyzer with integrated computer module, system reagents, and Abnormal Quality Control material and microfluidic test cartridges. The reagents included in the cartridge consist of: 1) Citrated Kaolin (CK); where the hemostasis process via the intrinsic pathway is measured, and clotting characteristics are described by the functional parameters Clotting Time (R), Speed of Clot Formation (K and Alpha angle), and Maximum Clot Strength (MA), 2) Citrated RapidTEG (CRT); where the 4 hemostasis process via both the intrinsic and extrinsic pathway is measured, and clotting characteristics are described by the functional parameter Maximum Clot Strength (MA), 3) Citrated Functional Fibrinogen (CFF); where the hemostasis process, in conjunction with the CK reagent, is monitored after blocking platelet contributions to clot strength, and clotting characteristics are described by the functional parameter Maximum Clot Strength (MA) and the Estimated Functional Fibrinogen Level (FLEV), 4) Citrated Kaolin Heparinase (CKH); where the effects of heparin in the blood stream, in conjunction with the CKH reagent, and heparin influence is determined by comparing Clotting Times (R) between the two tests. Reagents are dried-in-place within the cartridges during manufacturing. Abnormal Quality Control material is lyophilized and can be reconstituted with water as needed for WQC testing with reagent cartridges. J. Substantial Equivalence Information: 1. Predicate device name(s): Thromboelastograph® Coagualtion Analyzer (TEG)-5000 Series, Haemoscope Corporation 2. Predicate 510(k) number(s): K002177 3. Comparison with predicate: Similarities Item CORA System TEG 5000 Predicate Intended Use The CORA System is intended for in vitro diagnostic use to provide semi- quantitative indications of the hemostasis state of a blood sample. The CORA System records the kinetic changes in a venous sample of 3.2% citrated whole blood as the sample clots, and retracts in real time. The system output consists of a table of numerical values for parameters R, K, Angle, MA, and FLEV. The CORA System provides specific blood modifiers, in the form of reagents dried-in-place within CORA Cartridges. Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient's The TEG 5000 Series Analyzer is intended to be used to provide a quantitative and qualitative indication of the coagulation state of a blood sample by monitoring, measuring, analyzing and reporting coagulation parameter information. The Thrombelastograph (TEG) Coagulation Analyzer TEG-5000 Series records the kinetic changes in a sample of whole blood, plasma or platelet-rich-plasma as the sample clots, retracts and./or lyses (breaks apart). Results from the TEG Analyzer should not be the sole basis for a patient diagnosis; TEG results should be considered along with a 5 Similarities Item CORA System TEG 5000 Predicate medical history, the clinical picture and, if necessary, further hemostasis tests. The CORA System is intended for in vitro diagnostic use to provide semi- quantitative indications of the hemostasis state of a venous blood sample. The citrated Multichannel Cartridge, to be used with the CORA System instrument, contains four independent assays (CK, CRT, CKH and CFF), described below. The CK assay monitors the hemostasis process via the intrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameters Clotting Time (R), Speed of Clot Formation (K and Alpha angle) and Maximum Clot Strength (MA). The CRT assay monitors the hemostasis process via both the intrinsic and extrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameter Maximum Clot Strength (MA). The CRT MA parameter is equivalent to the CK MA parameter but the final MA value is reached more quickly using the CRT assay. The CKH assay monitors the effects of heparin in 3.2% citrated whole blood specimens on the CORA System Classification:
idK150041_s0_e2000	K150041.txt	panel	Hematology (81)	k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K150041 B. Purpose for Submission: Clearance of a new device C. Measurand: Coagulation factors (intrinsic and extrinsic pathway) and platelet aggregation D. Type of Test: Whole blood hemostasis E. Applicant: Coramed Technologies, LLC F. Proprietary and Established Names: CORA® (Coagulation Resonance Analysis) System The system includes the CORA instrument and the following reagents: CK (Citrated Kaolin), CRT (Citrated RapidTEG), CKH (Citrated Kaolin with Heparinase), and CFF (Citrated Functional Fibrinogen). G. Regulatory Information: 1. Regulation section: 21 CFR 864.5425, Multipurpose system for in vitro coagulation studies 21 CFR 864.5700, Automated platelet aggregation system 2. Classification: Class II 3. Product code: 2 JPA, System, Multipurpose For In Vitro Coagulation Control GGN, Plasma, Coagulation Control 4. Panel: Hematology (81) H. Intended Use: 1. Intended use(s): CORA Hemostasis System: The CORA System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a blood sample. The CORA System records the kinetic changes in a venous sample of 3.2% citrated whole blood as the sample clots, and retracts in real time. The system output consists of a table of numerical values for parameters R, K, Angle, MA, and FLEV. The CORA System provides specific blood modifiers, in the form of reagents dried-in-place within CORA Cartridges. Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient's medical history, the clinical picture and, if necessary, further hemostasis tests. Citrated Multichannel Cartridge: The CORA System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a venous blood sample. The citrated Multichannel Cartridge, to be used with the CORA System instrument, contains four independent assays (CK, CRT, CKH and CFF), described below. The CK assay monitors the hemostasis process via the intrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameters Clotting Time (R), Speed of Clot Formation (K and Alpha angle) and Maximum Clot Strength (MA). The CRT assay monitors the hemostasis process via both the intrinsic and extrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameter Maximum Clot Strength (MA). The CRT MA parameter is equivalent to the CK MA parameter but the final MA value is reached more quickly using the CRT assay. The CKH assay monitors the effects of heparin in 3.2% citrated whole blood specimens on the CORA System. CKH is used in conjunction with CK, and heparin influence is 3 determined by comparing Clotting Times (R) between the two tests. The CFF assay monitors hemostasis of 3.2% citrated whole blood specimens in the CORA System after blocking platelet contribution to clot strength. Clotting characteristics are described by the functional parameters Maximum Clot Strength (MA) and the Estimated Functional Fibrinogen Level (FLEV). Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient’s medical history, the clinical picture and, if necessary, further hemostasis tests. Abnormal Wet Quality Control (WQC) Material: The CORA System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a venous blood sample. The Abnormal Wet Quality Control Material is to be used for monitoring the accuracy and precision of tests carried out on the CORA System. Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient’s medical history, the clinical picture and, if necessary, further hemostasis tests. 2. Indication(s) for use: The indication for CORA System use is with adult patients where an evaluation of their blood hemostasis properties is desired. Hemostasis evaluations are commonly used to assess clinical conditions in cardiovascular surgery and cardiology procedures to assess hemorrhage or thrombosis conditions before, during and following the procedure. 3. Special conditions for use statement(s): Prescription Use Only 4. Special instrument requirements: For use with the CORA® (Coagulation Resonance Analysis) Instrument I. Device Description: The CORA System consists of a four-channel diagnostic analyzer with integrated computer module, system reagents, and Abnormal Quality Control material and microfluidic test cartridges. The reagents included in the cartridge consist of: 1) Citrated Kaolin (CK); where the hemostasis process via the intrinsic pathway is measured, and clotting characteristics are described by the functional parameters Clotting Time (R), Speed of Clot Formation (K and Alpha angle), and Maximum Clot Strength (MA), 2) Citrated RapidTEG (CRT); where the 4 hemostasis process via both the intrinsic and extrinsic pathway is measured, and clotting characteristics are described by the functional parameter Maximum Clot Strength (MA), 3) Citrated Functional Fibrinogen (CFF); where the hemostasis process, in conjunction with the CK reagent, is monitored after blocking platelet contributions to clot strength, and clotting characteristics are described by the functional parameter Maximum Clot Strength (MA) and the Estimated Functional Fibrinogen Level (FLEV), 4) Citrated Kaolin Heparinase (CKH); where the effects of heparin in the blood stream, in conjunction with the CKH reagent, and heparin influence is determined by comparing Clotting Times (R) between the two tests. Reagents are dried-in-place within the cartridges during manufacturing. Abnormal Quality Control material is lyophilized and can be reconstituted with water as needed for WQC testing with reagent cartridges. J. Substantial Equivalence Information: 1. Predicate device name(s): Thromboelastograph® Coagualtion Analyzer (TEG)-5000 Series, Haemoscope Corporation 2. Predicate 510(k) number(s): K002177 3. Comparison with predicate: Similarities Item CORA System TEG 5000 Predicate Intended Use The CORA System is intended for in vitro diagnostic use to provide semi- quantitative indications of the hemostasis state of a blood sample. The CORA System records the kinetic changes in a venous sample of 3.2% citrated whole blood as the sample clots, and retracts in real time. The system output consists of a table of numerical values for parameters R, K, Angle, MA, and FLEV. The CORA System provides specific blood modifiers, in the form of reagents dried-in-place within CORA Cartridges. Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient's The TEG 5000 Series Analyzer is intended to be used to provide a quantitative and qualitative indication of the coagulation state of a blood sample by monitoring, measuring, analyzing and reporting coagulation parameter information. The Thrombelastograph (TEG) Coagulation Analyzer TEG-5000 Series records the kinetic changes in a sample of whole blood, plasma or platelet-rich-plasma as the sample clots, retracts and./or lyses (breaks apart). Results from the TEG Analyzer should not be the sole basis for a patient diagnosis; TEG results should be considered along with a 5 Similarities Item CORA System TEG 5000 Predicate medical history, the clinical picture and, if necessary, further hemostasis tests. The CORA System is intended for in vitro diagnostic use to provide semi- quantitative indications of the hemostasis state of a venous blood sample. The citrated Multichannel Cartridge, to be used with the CORA System instrument, contains four independent assays (CK, CRT, CKH and CFF), described below. The CK assay monitors the hemostasis process via the intrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameters Clotting Time (R), Speed of Clot Formation (K and Alpha angle) and Maximum Clot Strength (MA). The CRT assay monitors the hemostasis process via both the intrinsic and extrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameter Maximum Clot Strength (MA). The CRT MA parameter is equivalent to the CK MA parameter but the final MA value is reached more quickly using the CRT assay. The CKH assay monitors the effects of heparin in 3.2% citrated whole blood specimens on the CORA System Panel:
idK150041_s0_e2000	K150041.txt	predicate device name	Thromboelastograph® Coagualtion Analyzer (TEG)-5000 Series, Haemoscope Corporation	STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K150041 B. Purpose for Submission: Clearance of a new device C. Measurand: Coagulation factors (intrinsic and extrinsic pathway) and platelet aggregation D. Type of Test: Whole blood hemostasis E. Applicant: Coramed Technologies, LLC F. Proprietary and Established Names: CORA® (Coagulation Resonance Analysis) System The system includes the CORA instrument and the following reagents: CK (Citrated Kaolin), CRT (Citrated RapidTEG), CKH (Citrated Kaolin with Heparinase), and CFF (Citrated Functional Fibrinogen). G. Regulatory Information: 1. Regulation section: 21 CFR 864.5425, Multipurpose system for in vitro coagulation studies 21 CFR 864.5700, Automated platelet aggregation system 2. Classification: Class II 3. Product code: 2 JPA, System, Multipurpose For In Vitro Coagulation Control GGN, Plasma, Coagulation Control 4. Panel: Hematology (81) H. Intended Use: 1. Intended use(s): CORA Hemostasis System: The CORA System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a blood sample. The CORA System records the kinetic changes in a venous sample of 3.2% citrated whole blood as the sample clots, and retracts in real time. The system output consists of a table of numerical values for parameters R, K, Angle, MA, and FLEV. The CORA System provides specific blood modifiers, in the form of reagents dried-in-place within CORA Cartridges. Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient's medical history, the clinical picture and, if necessary, further hemostasis tests. Citrated Multichannel Cartridge: The CORA System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a venous blood sample. The citrated Multichannel Cartridge, to be used with the CORA System instrument, contains four independent assays (CK, CRT, CKH and CFF), described below. The CK assay monitors the hemostasis process via the intrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameters Clotting Time (R), Speed of Clot Formation (K and Alpha angle) and Maximum Clot Strength (MA). The CRT assay monitors the hemostasis process via both the intrinsic and extrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameter Maximum Clot Strength (MA). The CRT MA parameter is equivalent to the CK MA parameter but the final MA value is reached more quickly using the CRT assay. The CKH assay monitors the effects of heparin in 3.2% citrated whole blood specimens on the CORA System. CKH is used in conjunction with CK, and heparin influence is 3 determined by comparing Clotting Times (R) between the two tests. The CFF assay monitors hemostasis of 3.2% citrated whole blood specimens in the CORA System after blocking platelet contribution to clot strength. Clotting characteristics are described by the functional parameters Maximum Clot Strength (MA) and the Estimated Functional Fibrinogen Level (FLEV). Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient’s medical history, the clinical picture and, if necessary, further hemostasis tests. Abnormal Wet Quality Control (WQC) Material: The CORA System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a venous blood sample. The Abnormal Wet Quality Control Material is to be used for monitoring the accuracy and precision of tests carried out on the CORA System. Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient’s medical history, the clinical picture and, if necessary, further hemostasis tests. 2. Indication(s) for use: The indication for CORA System use is with adult patients where an evaluation of their blood hemostasis properties is desired. Hemostasis evaluations are commonly used to assess clinical conditions in cardiovascular surgery and cardiology procedures to assess hemorrhage or thrombosis conditions before, during and following the procedure. 3. Special conditions for use statement(s): Prescription Use Only 4. Special instrument requirements: For use with the CORA® (Coagulation Resonance Analysis) Instrument I. Device Description: The CORA System consists of a four-channel diagnostic analyzer with integrated computer module, system reagents, and Abnormal Quality Control material and microfluidic test cartridges. The reagents included in the cartridge consist of: 1) Citrated Kaolin (CK); where the hemostasis process via the intrinsic pathway is measured, and clotting characteristics are described by the functional parameters Clotting Time (R), Speed of Clot Formation (K and Alpha angle), and Maximum Clot Strength (MA), 2) Citrated RapidTEG (CRT); where the 4 hemostasis process via both the intrinsic and extrinsic pathway is measured, and clotting characteristics are described by the functional parameter Maximum Clot Strength (MA), 3) Citrated Functional Fibrinogen (CFF); where the hemostasis process, in conjunction with the CK reagent, is monitored after blocking platelet contributions to clot strength, and clotting characteristics are described by the functional parameter Maximum Clot Strength (MA) and the Estimated Functional Fibrinogen Level (FLEV), 4) Citrated Kaolin Heparinase (CKH); where the effects of heparin in the blood stream, in conjunction with the CKH reagent, and heparin influence is determined by comparing Clotting Times (R) between the two tests. Reagents are dried-in-place within the cartridges during manufacturing. Abnormal Quality Control material is lyophilized and can be reconstituted with water as needed for WQC testing with reagent cartridges. J. Substantial Equivalence Information: 1. Predicate device name(s): Thromboelastograph® Coagualtion Analyzer (TEG)-5000 Series, Haemoscope Corporation 2. Predicate 510(k) number(s): K002177 3. Comparison with predicate: Similarities Item CORA System TEG 5000 Predicate Intended Use The CORA System is intended for in vitro diagnostic use to provide semi- quantitative indications of the hemostasis state of a blood sample. The CORA System records the kinetic changes in a venous sample of 3.2% citrated whole blood as the sample clots, and retracts in real time. The system output consists of a table of numerical values for parameters R, K, Angle, MA, and FLEV. The CORA System provides specific blood modifiers, in the form of reagents dried-in-place within CORA Cartridges. Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient's The TEG 5000 Series Analyzer is intended to be used to provide a quantitative and qualitative indication of the coagulation state of a blood sample by monitoring, measuring, analyzing and reporting coagulation parameter information. The Thrombelastograph (TEG) Coagulation Analyzer TEG-5000 Series records the kinetic changes in a sample of whole blood, plasma or platelet-rich-plasma as the sample clots, retracts and./or lyses (breaks apart). Results from the TEG Analyzer should not be the sole basis for a patient diagnosis; TEG results should be considered along with a 5 Similarities Item CORA System TEG 5000 Predicate medical history, the clinical picture and, if necessary, further hemostasis tests. The CORA System is intended for in vitro diagnostic use to provide semi- quantitative indications of the hemostasis state of a venous blood sample. The citrated Multichannel Cartridge, to be used with the CORA System instrument, contains four independent assays (CK, CRT, CKH and CFF), described below. The CK assay monitors the hemostasis process via the intrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameters Clotting Time (R), Speed of Clot Formation (K and Alpha angle) and Maximum Clot Strength (MA). The CRT assay monitors the hemostasis process via both the intrinsic and extrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameter Maximum Clot Strength (MA). The CRT MA parameter is equivalent to the CK MA parameter but the final MA value is reached more quickly using the CRT assay. The CKH assay monitors the effects of heparin in 3.2% citrated whole blood specimens on the CORA System Predicate device name:
idK150041_s0_e2000	K150041.txt	applicant	Coramed Technologies, LLC	) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM A. 510(k) Number: K150041 B. Purpose for Submission: Clearance of a new device C. Measurand: Coagulation factors (intrinsic and extrinsic pathway) and platelet aggregation D. Type of Test: Whole blood hemostasis E. Applicant: Coramed Technologies, LLC F. Proprietary and Established Names: CORA® (Coagulation Resonance Analysis) System The system includes the CORA instrument and the following reagents: CK (Citrated Kaolin), CRT (Citrated RapidTEG), CKH (Citrated Kaolin with Heparinase), and CFF (Citrated Functional Fibrinogen). G. Regulatory Information: 1. Regulation section: 21 CFR 864.5425, Multipurpose system for in vitro coagulation studies 21 CFR 864.5700, Automated platelet aggregation system 2. Classification: Class II 3. Product code: 2 JPA, System, Multipurpose For In Vitro Coagulation Control GGN, Plasma, Coagulation Control 4. Panel: Hematology (81) H. Intended Use: 1. Intended use(s): CORA Hemostasis System: The CORA System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a blood sample. The CORA System records the kinetic changes in a venous sample of 3.2% citrated whole blood as the sample clots, and retracts in real time. The system output consists of a table of numerical values for parameters R, K, Angle, MA, and FLEV. The CORA System provides specific blood modifiers, in the form of reagents dried-in-place within CORA Cartridges. Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient's medical history, the clinical picture and, if necessary, further hemostasis tests. Citrated Multichannel Cartridge: The CORA System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a venous blood sample. The citrated Multichannel Cartridge, to be used with the CORA System instrument, contains four independent assays (CK, CRT, CKH and CFF), described below. The CK assay monitors the hemostasis process via the intrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameters Clotting Time (R), Speed of Clot Formation (K and Alpha angle) and Maximum Clot Strength (MA). The CRT assay monitors the hemostasis process via both the intrinsic and extrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameter Maximum Clot Strength (MA). The CRT MA parameter is equivalent to the CK MA parameter but the final MA value is reached more quickly using the CRT assay. The CKH assay monitors the effects of heparin in 3.2% citrated whole blood specimens on the CORA System. CKH is used in conjunction with CK, and heparin influence is 3 determined by comparing Clotting Times (R) between the two tests. The CFF assay monitors hemostasis of 3.2% citrated whole blood specimens in the CORA System after blocking platelet contribution to clot strength. Clotting characteristics are described by the functional parameters Maximum Clot Strength (MA) and the Estimated Functional Fibrinogen Level (FLEV). Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient’s medical history, the clinical picture and, if necessary, further hemostasis tests. Abnormal Wet Quality Control (WQC) Material: The CORA System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a venous blood sample. The Abnormal Wet Quality Control Material is to be used for monitoring the accuracy and precision of tests carried out on the CORA System. Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient’s medical history, the clinical picture and, if necessary, further hemostasis tests. 2. Indication(s) for use: The indication for CORA System use is with adult patients where an evaluation of their blood hemostasis properties is desired. Hemostasis evaluations are commonly used to assess clinical conditions in cardiovascular surgery and cardiology procedures to assess hemorrhage or thrombosis conditions before, during and following the procedure. 3. Special conditions for use statement(s): Prescription Use Only 4. Special instrument requirements: For use with the CORA® (Coagulation Resonance Analysis) Instrument I. Device Description: The CORA System consists of a four-channel diagnostic analyzer with integrated computer module, system reagents, and Abnormal Quality Control material and microfluidic test cartridges. The reagents included in the cartridge consist of: 1) Citrated Kaolin (CK); where the hemostasis process via the intrinsic pathway is measured, and clotting characteristics are described by the functional parameters Clotting Time (R), Speed of Clot Formation (K and Alpha angle), and Maximum Clot Strength (MA), 2) Citrated RapidTEG (CRT); where the 4 hemostasis process via both the intrinsic and extrinsic pathway is measured, and clotting characteristics are described by the functional parameter Maximum Clot Strength (MA), 3) Citrated Functional Fibrinogen (CFF); where the hemostasis process, in conjunction with the CK reagent, is monitored after blocking platelet contributions to clot strength, and clotting characteristics are described by the functional parameter Maximum Clot Strength (MA) and the Estimated Functional Fibrinogen Level (FLEV), 4) Citrated Kaolin Heparinase (CKH); where the effects of heparin in the blood stream, in conjunction with the CKH reagent, and heparin influence is determined by comparing Clotting Times (R) between the two tests. Reagents are dried-in-place within the cartridges during manufacturing. Abnormal Quality Control material is lyophilized and can be reconstituted with water as needed for WQC testing with reagent cartridges. J. Substantial Equivalence Information: 1. Predicate device name(s): Thromboelastograph® Coagualtion Analyzer (TEG)-5000 Series, Haemoscope Corporation 2. Predicate 510(k) number(s): K002177 3. Comparison with predicate: Similarities Item CORA System TEG 5000 Predicate Intended Use The CORA System is intended for in vitro diagnostic use to provide semi- quantitative indications of the hemostasis state of a blood sample. The CORA System records the kinetic changes in a venous sample of 3.2% citrated whole blood as the sample clots, and retracts in real time. The system output consists of a table of numerical values for parameters R, K, Angle, MA, and FLEV. The CORA System provides specific blood modifiers, in the form of reagents dried-in-place within CORA Cartridges. Results from the CORA analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient's The TEG 5000 Series Analyzer is intended to be used to provide a quantitative and qualitative indication of the coagulation state of a blood sample by monitoring, measuring, analyzing and reporting coagulation parameter information. The Thrombelastograph (TEG) Coagulation Analyzer TEG-5000 Series records the kinetic changes in a sample of whole blood, plasma or platelet-rich-plasma as the sample clots, retracts and./or lyses (breaks apart). Results from the TEG Analyzer should not be the sole basis for a patient diagnosis; TEG results should be considered along with a 5 Similarities Item CORA System TEG 5000 Predicate medical history, the clinical picture and, if necessary, further hemostasis tests. The CORA System is intended for in vitro diagnostic use to provide semi- quantitative indications of the hemostasis state of a venous blood sample. The citrated Multichannel Cartridge, to be used with the CORA System instrument, contains four independent assays (CK, CRT, CKH and CFF), described below. The CK assay monitors the hemostasis process via the intrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameters Clotting Time (R), Speed of Clot Formation (K and Alpha angle) and Maximum Clot Strength (MA). The CRT assay monitors the hemostasis process via both the intrinsic and extrinsic pathway in 3.2% citrated whole blood specimens on the CORA System. Clotting characteristics are described by the functional parameter Maximum Clot Strength (MA). The CRT MA parameter is equivalent to the CK MA parameter but the final MA value is reached more quickly using the CRT assay. The CKH assay monitors the effects of heparin in 3.2% citrated whole blood specimens on the CORA System Applicant:
idK150041_s8000_e10000	K150041.txt	proposed labeling	The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.	7 152 Functional Fibrinogen MA (mm) 15.2 31.9 151 FLEV (mg/dL) 278.2 580.6 152 N. Instrument Name CORA Instrument O. System Descriptions: 1. Modes of Operation: Automatic 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: Manual patient identification entry 17 4. Specimen Sampling and Handling: Samples are collected in 3.2% sodium citrate. No further additives or preservatives are necessary to maintain the integrity of the sample, but samples must be used within two hours of draw to maintain in-use stability. The blood is applied to the sample port and is pulled into the four staging areas, mixed with dried reagents before transfer to the test cells. 5. Calibration: The CORA instrument is factory calibrated and does not require routine calibration. 6. Quality Control: Expected value Range for the Abnormal Wet Quality Control (WQC): Expected value ranges for the WQC material when used with CORA Multichannel Citrated cartridges were estimated, according to CLSI C28-A3c. Using three lots of WQC and three Multichannel Citrated cartridge lots, a total of over 135 test results were obtained. Reagent & Abnormal WQC (WQC) R (min) K (min) Angle (degrees) MA (mm) FLEV (mg/dl) CK - WQC 0.8–1.5 0.6–0.8 75–83 32–47 CRT – WQC 32–46 CKH – WQC 0.8–1.5 CFF – WQC 30–60 563–873 Citrated whole blood from a healthy individual should be tested in conjunction with the WQC. Laboratories should establish their own normal donor control for reagents and may consider the following: 1) Establish a normal donor control group for normal values using blood drawn from healthy adults, not exposed to medication affecting blood coagulation or platelet function. 2) If the results of donor control assays do not fall within the expected range, a second normal donor should be tested. If the second donor control assay results are also outside the expected range, the assay should be considered out of control and no further testing should be performed. Coramed recommends that, as a minimum, a normal donor control and the abnormal quality control material check be performed for each new lot of assay cartridges. Additional quality control checks on a monthly, weekly, daily or shift basis may be utilized based on the laboratory’s quality control policies. The end user should follow the recommendations of the applicable local and state regulatory guidelines and is advised to call technical support for assistance. 18 Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Proposed labeling:
idK150041_s8000_e10000	K150041.txt	conclusion	The submitted information in this premarket notification is complete and supports a substantial equivalence decision.	69.7 152 Functional Fibrinogen MA (mm) 15.2 31.9 151 FLEV (mg/dL) 278.2 580.6 152 N. Instrument Name CORA Instrument O. System Descriptions: 1. Modes of Operation: Automatic 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: Manual patient identification entry 17 4. Specimen Sampling and Handling: Samples are collected in 3.2% sodium citrate. No further additives or preservatives are necessary to maintain the integrity of the sample, but samples must be used within two hours of draw to maintain in-use stability. The blood is applied to the sample port and is pulled into the four staging areas, mixed with dried reagents before transfer to the test cells. 5. Calibration: The CORA instrument is factory calibrated and does not require routine calibration. 6. Quality Control: Expected value Range for the Abnormal Wet Quality Control (WQC): Expected value ranges for the WQC material when used with CORA Multichannel Citrated cartridges were estimated, according to CLSI C28-A3c. Using three lots of WQC and three Multichannel Citrated cartridge lots, a total of over 135 test results were obtained. Reagent & Abnormal WQC (WQC) R (min) K (min) Angle (degrees) MA (mm) FLEV (mg/dl) CK - WQC 0.8–1.5 0.6–0.8 75–83 32–47 CRT – WQC 32–46 CKH – WQC 0.8–1.5 CFF – WQC 30–60 563–873 Citrated whole blood from a healthy individual should be tested in conjunction with the WQC. Laboratories should establish their own normal donor control for reagents and may consider the following: 1) Establish a normal donor control group for normal values using blood drawn from healthy adults, not exposed to medication affecting blood coagulation or platelet function. 2) If the results of donor control assays do not fall within the expected range, a second normal donor should be tested. If the second donor control assay results are also outside the expected range, the assay should be considered out of control and no further testing should be performed. Coramed recommends that, as a minimum, a normal donor control and the abnormal quality control material check be performed for each new lot of assay cartridges. Additional quality control checks on a monthly, weekly, daily or shift basis may be utilized based on the laboratory’s quality control policies. The end user should follow the recommendations of the applicable local and state regulatory guidelines and is advised to call technical support for assistance. 18 Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Conclusion:
idK143329_s0_e2000	K143329.txt	purpose for submission	To obtain clearance for a new device, Amplivue® Trichomonas Assay	STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K143329 B. Purpose for Submission: To obtain clearance for a new device, Amplivue® Trichomonas Assay C. Measurand: A conserved multi-copy sequence of Trichomonas vaginalis genomic DNA D. Type of Test: Nucleic acid amplification assay (Helicase-dependent Amplification, HDA) E. Applicant: Quidel Corporation F. Proprietary and Established Names: Amplivue® Trichomonas Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.3860 2. Classification: Class II 3. Product code: OUY - Trichomonas vaginalis nucleic acid amplification test system 4. Panel: 83 - Microbiology 2 H. Intended Use: 1. Intended use(s): The AmpliVue® Trichomonas Assay is an in vitro diagnostic test, uses isothermal amplification technology (helicase-dependent amplification, HDA) for the qualitative detection of Trichomonas vaginalis nucleic acids isolated from clinician-collected vaginal swab specimens obtained from symptomatic or asymptomatic females to aid in the diagnosis of trichomoniasis. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: None I. Device Description: The AmpliVue® Trichomonas Assay is a self-contained disposable amplicon detection device that uses an isothermal amplification technology named Helicase-Dependent Amplification (HDA) for the detection of Trichomonas vaginalis in clinician-collected vaginal swabs from symptomatic and asymptomatic women. The assay targets a conserved multi-copy sequence of the T. vaginalis genomic DNA. The vaginal swab is eluted in a lysis tube, and the cells are lysed by heat treatment. After heat treatment, an aliquot of the lysed specimen is transferred into a dilution tube. An aliquot of this diluted sample is then added to a reaction tube containing a lyophilized mix of HDA reagents including primers specific for the amplification of a conserved DNA sequence only found in T. vaginalis. The assay includes an internal control for monitoring the integrity of the assay reagents and detection cassette as well as for monitoring HDA-inhibitors that may be present within the clinical specimens. The HDA reaction is asymmetric generating an excess of single-stranded DNA amplicons. The sequence specific capture probes as well as a biotinylated detection probe shared by both target and internal control bind to the corresponding single-stranded amplicons, forming dual labeled probe-amplicon hybrid. After completion of the HDA reaction, the reaction tube is transferred to a cassette for rapid detection and test result display. The dual-labeled probe-amplicon hybrid is detected by the lateral flow strip within the cassette. The bottom line captures the T. vaginalis amplicon and the top line captures the control amplicon. The biotin label binds the streptavidin-conjugated color particles for visualization and the test result is shown as a visible colored lines. 3 The cassette is comprised of two individual components: an amplicon cartridge that holds the running buffer and a single 0.2 mL thin wall reaction tube containing the amplified product; and the detection chamber which houses the amplicon cartridge and a vertical-flow DNA detection strip embedded into the cassette. The DNA detection strip is coated with different anti-hapten antibodies that serve as the T. vaginalis test (T) line and the control (C) line in the assay. A razor blade and a plastic pin located at the bottom of the detection chamber open the HDA reaction tube and the running buffer bulb when the handle of the cassette is closed. The mixture flows through a fiberglass paper connected to the DNA detection strip containing a fiberglass pad pre-loaded with streptavidin-conjugated color particles for color visualization. Detection of T. vaginalis DNA is reported whenever the T2 (Test line 2) is visible through the detection window of the cassette. The presence of T1 line is an invalid result for this assay and the test should be repeated with the lysed specimen. The presence of the C line is not required for positive results. No detection of T. vaginalis DNA is reported when only the C line is displayed. The assay is regarded as invalid when neither line is displayed. J. Substantial Equivalence Information: 1. Predicate device name(s): APTIMA Trichomonas vaginalis Assay (PANTHER® System) 2. Predicate 510(k) number(s): K122062 4 3. Comparison with predicate: Similarities Item Device AmpliVue® Trichomonas Assay Predicate APTIMA Trichomonas vaginalis Assay (PANTHER® System) (K122062) Intended Use The AmpliVue® Trichomonas Assay is an in vitro diagnostic test, uses isothermal amplification technology (helicase-dependent amplification, HDA) for the qualitative detection of Trichomonas vaginalis nucleic acids isolated from clinician- collected vaginal swab specimens obtained from symptomatic or asymptomatic females to aid in the diagnosis of trichomoniasis. The APTIMA Trichomonas vaginalis Assay is an in vitro qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the PANTHER System. The assay may be used to test the following specimens from symptomatic or asymptomatic women: clinician-collected endocervical swabs, clinician- collected vaginal swabs, and specimens collected in PreservCyt Solution. Assay Results Qualitative Qualitative Differences Item Device AmpliVue® Trichomonas Assay Predicate APTIMA Trichomonas vaginalis Assay (PANTHER® System) (K122062) Sample Types Clinician-collected Vaginal Swabs Clinician-collected Vaginal Swabs, Endocervical Swabs, ThinPrep in PreservCyt solution Target Sequence Detected Repeated DNA fragment located in T. vaginalis genome T. vaginalis ribosomal RNA (rRNA) Amplification Technology Helicase-dependent amplification (HDA) Transcription Mediated Amplification (TMA) Hybridization Protection Assay (HPA) Self-Contained System Assay after sample preparation No Yes Detection Technique Manual Automated Instrument None PANTHER System 5 K. Standard/Guidance Document Referenced (if applicable): None L. Test Principle: The AmpliVue® Trichomonas Assay uses HAD to detect T. vaginalis genomic DNA in vaginal swab specimens. The vaginal swab is eluted in a lysis tube, and the cells are lysed by heat treatment. An aliquot of the lysed specimen is transferred into a dilution tube which is then added to a reaction tube containing a lyophilized mix of HDA reagents including primers specific for the amplification of a conserved DNA sequence of T. vaginalis. The reaction tube also includes an internal control to confirm the integrity of the assay reagents and cassette detection as well as to monitor for HDA-inhibitors that may be present within the clinical specimens. The sequence specific capture probes as well as a biotinylated detection probe are shared by T. vaginalis target sequences and the internal control bind to the corresponding single-stranded amplicons (product of HDA reaction), forming a dual labeled probe-amplicon hybrid. After completion of the HDA reaction, the reaction tube is transferred to a cassette for rapid detection. The test result is displayed in the window of the cassette as test and/or control colored lines visible to the naked eye. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: With-in laboratory Precision With-in laboratory precision for AmpliVue® Trichomonas Assay was determined via a study, where a four-member panel (3x LoD (Moderate positive), 1x LoD (Low positive), 1/9x LoD (High negative, C20 to C80), and a negative sample) was tested at one site in a random manner by two operators, three samples per concentration, twice a day for 12 days. All negative samples generated negative results for T. vaginalis. The percent agreement with positive results for High negative samples is 39% (within the target range of 20 to 80%). A 100% agreement was observed with expected results for Low positive and Moderate positive samples. 6 Concentration Operator #1 Operator #2 Overall Percent Agreement 95% Confidence Interval #expected results/# tested % Agreement 95% Confidence Interval #expected results/# tested % Agreement 95% Confidence Interval High Negative* (34 trophozoites /mL) 11/36 31% 18.0% to 46.9% 17/36 47% 32.0% to 63.0% 28/72 39% 28.5% to 50.4% Low Positive (307 trophozoites /mL) 36/36 100% 90.4% to 100 Purpose for submission:
idK143329_s0_e2000	K143329.txt	measurand	A conserved multi-copy sequence of Trichomonas vaginalis genomic DNA	STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K143329 B. Purpose for Submission: To obtain clearance for a new device, Amplivue® Trichomonas Assay C. Measurand: A conserved multi-copy sequence of Trichomonas vaginalis genomic DNA D. Type of Test: Nucleic acid amplification assay (Helicase-dependent Amplification, HDA) E. Applicant: Quidel Corporation F. Proprietary and Established Names: Amplivue® Trichomonas Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.3860 2. Classification: Class II 3. Product code: OUY - Trichomonas vaginalis nucleic acid amplification test system 4. Panel: 83 - Microbiology 2 H. Intended Use: 1. Intended use(s): The AmpliVue® Trichomonas Assay is an in vitro diagnostic test, uses isothermal amplification technology (helicase-dependent amplification, HDA) for the qualitative detection of Trichomonas vaginalis nucleic acids isolated from clinician-collected vaginal swab specimens obtained from symptomatic or asymptomatic females to aid in the diagnosis of trichomoniasis. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: None I. Device Description: The AmpliVue® Trichomonas Assay is a self-contained disposable amplicon detection device that uses an isothermal amplification technology named Helicase-Dependent Amplification (HDA) for the detection of Trichomonas vaginalis in clinician-collected vaginal swabs from symptomatic and asymptomatic women. The assay targets a conserved multi-copy sequence of the T. vaginalis genomic DNA. The vaginal swab is eluted in a lysis tube, and the cells are lysed by heat treatment. After heat treatment, an aliquot of the lysed specimen is transferred into a dilution tube. An aliquot of this diluted sample is then added to a reaction tube containing a lyophilized mix of HDA reagents including primers specific for the amplification of a conserved DNA sequence only found in T. vaginalis. The assay includes an internal control for monitoring the integrity of the assay reagents and detection cassette as well as for monitoring HDA-inhibitors that may be present within the clinical specimens. The HDA reaction is asymmetric generating an excess of single-stranded DNA amplicons. The sequence specific capture probes as well as a biotinylated detection probe shared by both target and internal control bind to the corresponding single-stranded amplicons, forming dual labeled probe-amplicon hybrid. After completion of the HDA reaction, the reaction tube is transferred to a cassette for rapid detection and test result display. The dual-labeled probe-amplicon hybrid is detected by the lateral flow strip within the cassette. The bottom line captures the T. vaginalis amplicon and the top line captures the control amplicon. The biotin label binds the streptavidin-conjugated color particles for visualization and the test result is shown as a visible colored lines. 3 The cassette is comprised of two individual components: an amplicon cartridge that holds the running buffer and a single 0.2 mL thin wall reaction tube containing the amplified product; and the detection chamber which houses the amplicon cartridge and a vertical-flow DNA detection strip embedded into the cassette. The DNA detection strip is coated with different anti-hapten antibodies that serve as the T. vaginalis test (T) line and the control (C) line in the assay. A razor blade and a plastic pin located at the bottom of the detection chamber open the HDA reaction tube and the running buffer bulb when the handle of the cassette is closed. The mixture flows through a fiberglass paper connected to the DNA detection strip containing a fiberglass pad pre-loaded with streptavidin-conjugated color particles for color visualization. Detection of T. vaginalis DNA is reported whenever the T2 (Test line 2) is visible through the detection window of the cassette. The presence of T1 line is an invalid result for this assay and the test should be repeated with the lysed specimen. The presence of the C line is not required for positive results. No detection of T. vaginalis DNA is reported when only the C line is displayed. The assay is regarded as invalid when neither line is displayed. J. Substantial Equivalence Information: 1. Predicate device name(s): APTIMA Trichomonas vaginalis Assay (PANTHER® System) 2. Predicate 510(k) number(s): K122062 4 3. Comparison with predicate: Similarities Item Device AmpliVue® Trichomonas Assay Predicate APTIMA Trichomonas vaginalis Assay (PANTHER® System) (K122062) Intended Use The AmpliVue® Trichomonas Assay is an in vitro diagnostic test, uses isothermal amplification technology (helicase-dependent amplification, HDA) for the qualitative detection of Trichomonas vaginalis nucleic acids isolated from clinician- collected vaginal swab specimens obtained from symptomatic or asymptomatic females to aid in the diagnosis of trichomoniasis. The APTIMA Trichomonas vaginalis Assay is an in vitro qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the PANTHER System. The assay may be used to test the following specimens from symptomatic or asymptomatic women: clinician-collected endocervical swabs, clinician- collected vaginal swabs, and specimens collected in PreservCyt Solution. Assay Results Qualitative Qualitative Differences Item Device AmpliVue® Trichomonas Assay Predicate APTIMA Trichomonas vaginalis Assay (PANTHER® System) (K122062) Sample Types Clinician-collected Vaginal Swabs Clinician-collected Vaginal Swabs, Endocervical Swabs, ThinPrep in PreservCyt solution Target Sequence Detected Repeated DNA fragment located in T. vaginalis genome T. vaginalis ribosomal RNA (rRNA) Amplification Technology Helicase-dependent amplification (HDA) Transcription Mediated Amplification (TMA) Hybridization Protection Assay (HPA) Self-Contained System Assay after sample preparation No Yes Detection Technique Manual Automated Instrument None PANTHER System 5 K. Standard/Guidance Document Referenced (if applicable): None L. Test Principle: The AmpliVue® Trichomonas Assay uses HAD to detect T. vaginalis genomic DNA in vaginal swab specimens. The vaginal swab is eluted in a lysis tube, and the cells are lysed by heat treatment. An aliquot of the lysed specimen is transferred into a dilution tube which is then added to a reaction tube containing a lyophilized mix of HDA reagents including primers specific for the amplification of a conserved DNA sequence of T. vaginalis. The reaction tube also includes an internal control to confirm the integrity of the assay reagents and cassette detection as well as to monitor for HDA-inhibitors that may be present within the clinical specimens. The sequence specific capture probes as well as a biotinylated detection probe are shared by T. vaginalis target sequences and the internal control bind to the corresponding single-stranded amplicons (product of HDA reaction), forming a dual labeled probe-amplicon hybrid. After completion of the HDA reaction, the reaction tube is transferred to a cassette for rapid detection. The test result is displayed in the window of the cassette as test and/or control colored lines visible to the naked eye. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: With-in laboratory Precision With-in laboratory precision for AmpliVue® Trichomonas Assay was determined via a study, where a four-member panel (3x LoD (Moderate positive), 1x LoD (Low positive), 1/9x LoD (High negative, C20 to C80), and a negative sample) was tested at one site in a random manner by two operators, three samples per concentration, twice a day for 12 days. All negative samples generated negative results for T. vaginalis. The percent agreement with positive results for High negative samples is 39% (within the target range of 20 to 80%). A 100% agreement was observed with expected results for Low positive and Moderate positive samples. 6 Concentration Operator #1 Operator #2 Overall Percent Agreement 95% Confidence Interval #expected results/# tested % Agreement 95% Confidence Interval #expected results/# tested % Agreement 95% Confidence Interval High Negative* (34 trophozoites /mL) 11/36 31% 18.0% to 46.9% 17/36 47% 32.0% to 63.0% 28/72 39% 28.5% to 50.4% Low Positive (307 trophozoites /mL) 36/36 100% 90.4% to 100 Measurand:
idK143329_s0_e2000	K143329.txt	type of test	Nucleic acid amplification assay (Helicase-dependent Amplification, HDA)	SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K143329 B. Purpose for Submission: To obtain clearance for a new device, Amplivue® Trichomonas Assay C. Measurand: A conserved multi-copy sequence of Trichomonas vaginalis genomic DNA D. Type of Test: Nucleic acid amplification assay (Helicase-dependent Amplification, HDA) E. Applicant: Quidel Corporation F. Proprietary and Established Names: Amplivue® Trichomonas Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.3860 2. Classification: Class II 3. Product code: OUY - Trichomonas vaginalis nucleic acid amplification test system 4. Panel: 83 - Microbiology 2 H. Intended Use: 1. Intended use(s): The AmpliVue® Trichomonas Assay is an in vitro diagnostic test, uses isothermal amplification technology (helicase-dependent amplification, HDA) for the qualitative detection of Trichomonas vaginalis nucleic acids isolated from clinician-collected vaginal swab specimens obtained from symptomatic or asymptomatic females to aid in the diagnosis of trichomoniasis. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: None I. Device Description: The AmpliVue® Trichomonas Assay is a self-contained disposable amplicon detection device that uses an isothermal amplification technology named Helicase-Dependent Amplification (HDA) for the detection of Trichomonas vaginalis in clinician-collected vaginal swabs from symptomatic and asymptomatic women. The assay targets a conserved multi-copy sequence of the T. vaginalis genomic DNA. The vaginal swab is eluted in a lysis tube, and the cells are lysed by heat treatment. After heat treatment, an aliquot of the lysed specimen is transferred into a dilution tube. An aliquot of this diluted sample is then added to a reaction tube containing a lyophilized mix of HDA reagents including primers specific for the amplification of a conserved DNA sequence only found in T. vaginalis. The assay includes an internal control for monitoring the integrity of the assay reagents and detection cassette as well as for monitoring HDA-inhibitors that may be present within the clinical specimens. The HDA reaction is asymmetric generating an excess of single-stranded DNA amplicons. The sequence specific capture probes as well as a biotinylated detection probe shared by both target and internal control bind to the corresponding single-stranded amplicons, forming dual labeled probe-amplicon hybrid. After completion of the HDA reaction, the reaction tube is transferred to a cassette for rapid detection and test result display. The dual-labeled probe-amplicon hybrid is detected by the lateral flow strip within the cassette. The bottom line captures the T. vaginalis amplicon and the top line captures the control amplicon. The biotin label binds the streptavidin-conjugated color particles for visualization and the test result is shown as a visible colored lines. 3 The cassette is comprised of two individual components: an amplicon cartridge that holds the running buffer and a single 0.2 mL thin wall reaction tube containing the amplified product; and the detection chamber which houses the amplicon cartridge and a vertical-flow DNA detection strip embedded into the cassette. The DNA detection strip is coated with different anti-hapten antibodies that serve as the T. vaginalis test (T) line and the control (C) line in the assay. A razor blade and a plastic pin located at the bottom of the detection chamber open the HDA reaction tube and the running buffer bulb when the handle of the cassette is closed. The mixture flows through a fiberglass paper connected to the DNA detection strip containing a fiberglass pad pre-loaded with streptavidin-conjugated color particles for color visualization. Detection of T. vaginalis DNA is reported whenever the T2 (Test line 2) is visible through the detection window of the cassette. The presence of T1 line is an invalid result for this assay and the test should be repeated with the lysed specimen. The presence of the C line is not required for positive results. No detection of T. vaginalis DNA is reported when only the C line is displayed. The assay is regarded as invalid when neither line is displayed. J. Substantial Equivalence Information: 1. Predicate device name(s): APTIMA Trichomonas vaginalis Assay (PANTHER® System) 2. Predicate 510(k) number(s): K122062 4 3. Comparison with predicate: Similarities Item Device AmpliVue® Trichomonas Assay Predicate APTIMA Trichomonas vaginalis Assay (PANTHER® System) (K122062) Intended Use The AmpliVue® Trichomonas Assay is an in vitro diagnostic test, uses isothermal amplification technology (helicase-dependent amplification, HDA) for the qualitative detection of Trichomonas vaginalis nucleic acids isolated from clinician- collected vaginal swab specimens obtained from symptomatic or asymptomatic females to aid in the diagnosis of trichomoniasis. The APTIMA Trichomonas vaginalis Assay is an in vitro qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the PANTHER System. The assay may be used to test the following specimens from symptomatic or asymptomatic women: clinician-collected endocervical swabs, clinician- collected vaginal swabs, and specimens collected in PreservCyt Solution. Assay Results Qualitative Qualitative Differences Item Device AmpliVue® Trichomonas Assay Predicate APTIMA Trichomonas vaginalis Assay (PANTHER® System) (K122062) Sample Types Clinician-collected Vaginal Swabs Clinician-collected Vaginal Swabs, Endocervical Swabs, ThinPrep in PreservCyt solution Target Sequence Detected Repeated DNA fragment located in T. vaginalis genome T. vaginalis ribosomal RNA (rRNA) Amplification Technology Helicase-dependent amplification (HDA) Transcription Mediated Amplification (TMA) Hybridization Protection Assay (HPA) Self-Contained System Assay after sample preparation No Yes Detection Technique Manual Automated Instrument None PANTHER System 5 K. Standard/Guidance Document Referenced (if applicable): None L. Test Principle: The AmpliVue® Trichomonas Assay uses HAD to detect T. vaginalis genomic DNA in vaginal swab specimens. The vaginal swab is eluted in a lysis tube, and the cells are lysed by heat treatment. An aliquot of the lysed specimen is transferred into a dilution tube which is then added to a reaction tube containing a lyophilized mix of HDA reagents including primers specific for the amplification of a conserved DNA sequence of T. vaginalis. The reaction tube also includes an internal control to confirm the integrity of the assay reagents and cassette detection as well as to monitor for HDA-inhibitors that may be present within the clinical specimens. The sequence specific capture probes as well as a biotinylated detection probe are shared by T. vaginalis target sequences and the internal control bind to the corresponding single-stranded amplicons (product of HDA reaction), forming a dual labeled probe-amplicon hybrid. After completion of the HDA reaction, the reaction tube is transferred to a cassette for rapid detection. The test result is displayed in the window of the cassette as test and/or control colored lines visible to the naked eye. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: With-in laboratory Precision With-in laboratory precision for AmpliVue® Trichomonas Assay was determined via a study, where a four-member panel (3x LoD (Moderate positive), 1x LoD (Low positive), 1/9x LoD (High negative, C20 to C80), and a negative sample) was tested at one site in a random manner by two operators, three samples per concentration, twice a day for 12 days. All negative samples generated negative results for T. vaginalis. The percent agreement with positive results for High negative samples is 39% (within the target range of 20 to 80%). A 100% agreement was observed with expected results for Low positive and Moderate positive samples. 6 Concentration Operator #1 Operator #2 Overall Percent Agreement 95% Confidence Interval #expected results/# tested % Agreement 95% Confidence Interval #expected results/# tested % Agreement 95% Confidence Interval High Negative* (34 trophozoites /mL) 11/36 31% 18.0% to 46.9% 17/36 47% 32.0% to 63.0% 28/72 39% 28.5% to 50.4% Low Positive (307 trophozoites /mL) 36/36 100% 90.4% to 100 Type of test:
idK143329_s0_e2000	K143329.txt	classification	Class II	) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K143329 B. Purpose for Submission: To obtain clearance for a new device, Amplivue® Trichomonas Assay C. Measurand: A conserved multi-copy sequence of Trichomonas vaginalis genomic DNA D. Type of Test: Nucleic acid amplification assay (Helicase-dependent Amplification, HDA) E. Applicant: Quidel Corporation F. Proprietary and Established Names: Amplivue® Trichomonas Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.3860 2. Classification: Class II 3. Product code: OUY - Trichomonas vaginalis nucleic acid amplification test system 4. Panel: 83 - Microbiology 2 H. Intended Use: 1. Intended use(s): The AmpliVue® Trichomonas Assay is an in vitro diagnostic test, uses isothermal amplification technology (helicase-dependent amplification, HDA) for the qualitative detection of Trichomonas vaginalis nucleic acids isolated from clinician-collected vaginal swab specimens obtained from symptomatic or asymptomatic females to aid in the diagnosis of trichomoniasis. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: None I. Device Description: The AmpliVue® Trichomonas Assay is a self-contained disposable amplicon detection device that uses an isothermal amplification technology named Helicase-Dependent Amplification (HDA) for the detection of Trichomonas vaginalis in clinician-collected vaginal swabs from symptomatic and asymptomatic women. The assay targets a conserved multi-copy sequence of the T. vaginalis genomic DNA. The vaginal swab is eluted in a lysis tube, and the cells are lysed by heat treatment. After heat treatment, an aliquot of the lysed specimen is transferred into a dilution tube. An aliquot of this diluted sample is then added to a reaction tube containing a lyophilized mix of HDA reagents including primers specific for the amplification of a conserved DNA sequence only found in T. vaginalis. The assay includes an internal control for monitoring the integrity of the assay reagents and detection cassette as well as for monitoring HDA-inhibitors that may be present within the clinical specimens. The HDA reaction is asymmetric generating an excess of single-stranded DNA amplicons. The sequence specific capture probes as well as a biotinylated detection probe shared by both target and internal control bind to the corresponding single-stranded amplicons, forming dual labeled probe-amplicon hybrid. After completion of the HDA reaction, the reaction tube is transferred to a cassette for rapid detection and test result display. The dual-labeled probe-amplicon hybrid is detected by the lateral flow strip within the cassette. The bottom line captures the T. vaginalis amplicon and the top line captures the control amplicon. The biotin label binds the streptavidin-conjugated color particles for visualization and the test result is shown as a visible colored lines. 3 The cassette is comprised of two individual components: an amplicon cartridge that holds the running buffer and a single 0.2 mL thin wall reaction tube containing the amplified product; and the detection chamber which houses the amplicon cartridge and a vertical-flow DNA detection strip embedded into the cassette. The DNA detection strip is coated with different anti-hapten antibodies that serve as the T. vaginalis test (T) line and the control (C) line in the assay. A razor blade and a plastic pin located at the bottom of the detection chamber open the HDA reaction tube and the running buffer bulb when the handle of the cassette is closed. The mixture flows through a fiberglass paper connected to the DNA detection strip containing a fiberglass pad pre-loaded with streptavidin-conjugated color particles for color visualization. Detection of T. vaginalis DNA is reported whenever the T2 (Test line 2) is visible through the detection window of the cassette. The presence of T1 line is an invalid result for this assay and the test should be repeated with the lysed specimen. The presence of the C line is not required for positive results. No detection of T. vaginalis DNA is reported when only the C line is displayed. The assay is regarded as invalid when neither line is displayed. J. Substantial Equivalence Information: 1. Predicate device name(s): APTIMA Trichomonas vaginalis Assay (PANTHER® System) 2. Predicate 510(k) number(s): K122062 4 3. Comparison with predicate: Similarities Item Device AmpliVue® Trichomonas Assay Predicate APTIMA Trichomonas vaginalis Assay (PANTHER® System) (K122062) Intended Use The AmpliVue® Trichomonas Assay is an in vitro diagnostic test, uses isothermal amplification technology (helicase-dependent amplification, HDA) for the qualitative detection of Trichomonas vaginalis nucleic acids isolated from clinician- collected vaginal swab specimens obtained from symptomatic or asymptomatic females to aid in the diagnosis of trichomoniasis. The APTIMA Trichomonas vaginalis Assay is an in vitro qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the PANTHER System. The assay may be used to test the following specimens from symptomatic or asymptomatic women: clinician-collected endocervical swabs, clinician- collected vaginal swabs, and specimens collected in PreservCyt Solution. Assay Results Qualitative Qualitative Differences Item Device AmpliVue® Trichomonas Assay Predicate APTIMA Trichomonas vaginalis Assay (PANTHER® System) (K122062) Sample Types Clinician-collected Vaginal Swabs Clinician-collected Vaginal Swabs, Endocervical Swabs, ThinPrep in PreservCyt solution Target Sequence Detected Repeated DNA fragment located in T. vaginalis genome T. vaginalis ribosomal RNA (rRNA) Amplification Technology Helicase-dependent amplification (HDA) Transcription Mediated Amplification (TMA) Hybridization Protection Assay (HPA) Self-Contained System Assay after sample preparation No Yes Detection Technique Manual Automated Instrument None PANTHER System 5 K. Standard/Guidance Document Referenced (if applicable): None L. Test Principle: The AmpliVue® Trichomonas Assay uses HAD to detect T. vaginalis genomic DNA in vaginal swab specimens. The vaginal swab is eluted in a lysis tube, and the cells are lysed by heat treatment. An aliquot of the lysed specimen is transferred into a dilution tube which is then added to a reaction tube containing a lyophilized mix of HDA reagents including primers specific for the amplification of a conserved DNA sequence of T. vaginalis. The reaction tube also includes an internal control to confirm the integrity of the assay reagents and cassette detection as well as to monitor for HDA-inhibitors that may be present within the clinical specimens. The sequence specific capture probes as well as a biotinylated detection probe are shared by T. vaginalis target sequences and the internal control bind to the corresponding single-stranded amplicons (product of HDA reaction), forming a dual labeled probe-amplicon hybrid. After completion of the HDA reaction, the reaction tube is transferred to a cassette for rapid detection. The test result is displayed in the window of the cassette as test and/or control colored lines visible to the naked eye. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: With-in laboratory Precision With-in laboratory precision for AmpliVue® Trichomonas Assay was determined via a study, where a four-member panel (3x LoD (Moderate positive), 1x LoD (Low positive), 1/9x LoD (High negative, C20 to C80), and a negative sample) was tested at one site in a random manner by two operators, three samples per concentration, twice a day for 12 days. All negative samples generated negative results for T. vaginalis. The percent agreement with positive results for High negative samples is 39% (within the target range of 20 to 80%). A 100% agreement was observed with expected results for Low positive and Moderate positive samples. 6 Concentration Operator #1 Operator #2 Overall Percent Agreement 95% Confidence Interval #expected results/# tested % Agreement 95% Confidence Interval #expected results/# tested % Agreement 95% Confidence Interval High Negative* (34 trophozoites /mL) 11/36 31% 18.0% to 46.9% 17/36 47% 32.0% to 63.0% 28/72 39% 28.5% to 50.4% Low Positive (307 trophozoites /mL) 36/36 100% 90.4% to 100 Classification:
idK143329_s0_e2000	K143329.txt	product code	OUY - Trichomonas vaginalis nucleic acid amplification test system	) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K143329 B. Purpose for Submission: To obtain clearance for a new device, Amplivue® Trichomonas Assay C. Measurand: A conserved multi-copy sequence of Trichomonas vaginalis genomic DNA D. Type of Test: Nucleic acid amplification assay (Helicase-dependent Amplification, HDA) E. Applicant: Quidel Corporation F. Proprietary and Established Names: Amplivue® Trichomonas Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.3860 2. Classification: Class II 3. Product code: OUY - Trichomonas vaginalis nucleic acid amplification test system 4. Panel: 83 - Microbiology 2 H. Intended Use: 1. Intended use(s): The AmpliVue® Trichomonas Assay is an in vitro diagnostic test, uses isothermal amplification technology (helicase-dependent amplification, HDA) for the qualitative detection of Trichomonas vaginalis nucleic acids isolated from clinician-collected vaginal swab specimens obtained from symptomatic or asymptomatic females to aid in the diagnosis of trichomoniasis. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: None I. Device Description: The AmpliVue® Trichomonas Assay is a self-contained disposable amplicon detection device that uses an isothermal amplification technology named Helicase-Dependent Amplification (HDA) for the detection of Trichomonas vaginalis in clinician-collected vaginal swabs from symptomatic and asymptomatic women. The assay targets a conserved multi-copy sequence of the T. vaginalis genomic DNA. The vaginal swab is eluted in a lysis tube, and the cells are lysed by heat treatment. After heat treatment, an aliquot of the lysed specimen is transferred into a dilution tube. An aliquot of this diluted sample is then added to a reaction tube containing a lyophilized mix of HDA reagents including primers specific for the amplification of a conserved DNA sequence only found in T. vaginalis. The assay includes an internal control for monitoring the integrity of the assay reagents and detection cassette as well as for monitoring HDA-inhibitors that may be present within the clinical specimens. The HDA reaction is asymmetric generating an excess of single-stranded DNA amplicons. The sequence specific capture probes as well as a biotinylated detection probe shared by both target and internal control bind to the corresponding single-stranded amplicons, forming dual labeled probe-amplicon hybrid. After completion of the HDA reaction, the reaction tube is transferred to a cassette for rapid detection and test result display. The dual-labeled probe-amplicon hybrid is detected by the lateral flow strip within the cassette. The bottom line captures the T. vaginalis amplicon and the top line captures the control amplicon. The biotin label binds the streptavidin-conjugated color particles for visualization and the test result is shown as a visible colored lines. 3 The cassette is comprised of two individual components: an amplicon cartridge that holds the running buffer and a single 0.2 mL thin wall reaction tube containing the amplified product; and the detection chamber which houses the amplicon cartridge and a vertical-flow DNA detection strip embedded into the cassette. The DNA detection strip is coated with different anti-hapten antibodies that serve as the T. vaginalis test (T) line and the control (C) line in the assay. A razor blade and a plastic pin located at the bottom of the detection chamber open the HDA reaction tube and the running buffer bulb when the handle of the cassette is closed. The mixture flows through a fiberglass paper connected to the DNA detection strip containing a fiberglass pad pre-loaded with streptavidin-conjugated color particles for color visualization. Detection of T. vaginalis DNA is reported whenever the T2 (Test line 2) is visible through the detection window of the cassette. The presence of T1 line is an invalid result for this assay and the test should be repeated with the lysed specimen. The presence of the C line is not required for positive results. No detection of T. vaginalis DNA is reported when only the C line is displayed. The assay is regarded as invalid when neither line is displayed. J. Substantial Equivalence Information: 1. Predicate device name(s): APTIMA Trichomonas vaginalis Assay (PANTHER® System) 2. Predicate 510(k) number(s): K122062 4 3. Comparison with predicate: Similarities Item Device AmpliVue® Trichomonas Assay Predicate APTIMA Trichomonas vaginalis Assay (PANTHER® System) (K122062) Intended Use The AmpliVue® Trichomonas Assay is an in vitro diagnostic test, uses isothermal amplification technology (helicase-dependent amplification, HDA) for the qualitative detection of Trichomonas vaginalis nucleic acids isolated from clinician- collected vaginal swab specimens obtained from symptomatic or asymptomatic females to aid in the diagnosis of trichomoniasis. The APTIMA Trichomonas vaginalis Assay is an in vitro qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the PANTHER System. The assay may be used to test the following specimens from symptomatic or asymptomatic women: clinician-collected endocervical swabs, clinician- collected vaginal swabs, and specimens collected in PreservCyt Solution. Assay Results Qualitative Qualitative Differences Item Device AmpliVue® Trichomonas Assay Predicate APTIMA Trichomonas vaginalis Assay (PANTHER® System) (K122062) Sample Types Clinician-collected Vaginal Swabs Clinician-collected Vaginal Swabs, Endocervical Swabs, ThinPrep in PreservCyt solution Target Sequence Detected Repeated DNA fragment located in T. vaginalis genome T. vaginalis ribosomal RNA (rRNA) Amplification Technology Helicase-dependent amplification (HDA) Transcription Mediated Amplification (TMA) Hybridization Protection Assay (HPA) Self-Contained System Assay after sample preparation No Yes Detection Technique Manual Automated Instrument None PANTHER System 5 K. Standard/Guidance Document Referenced (if applicable): None L. Test Principle: The AmpliVue® Trichomonas Assay uses HAD to detect T. vaginalis genomic DNA in vaginal swab specimens. The vaginal swab is eluted in a lysis tube, and the cells are lysed by heat treatment. An aliquot of the lysed specimen is transferred into a dilution tube which is then added to a reaction tube containing a lyophilized mix of HDA reagents including primers specific for the amplification of a conserved DNA sequence of T. vaginalis. The reaction tube also includes an internal control to confirm the integrity of the assay reagents and cassette detection as well as to monitor for HDA-inhibitors that may be present within the clinical specimens. The sequence specific capture probes as well as a biotinylated detection probe are shared by T. vaginalis target sequences and the internal control bind to the corresponding single-stranded amplicons (product of HDA reaction), forming a dual labeled probe-amplicon hybrid. After completion of the HDA reaction, the reaction tube is transferred to a cassette for rapid detection. The test result is displayed in the window of the cassette as test and/or control colored lines visible to the naked eye. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: With-in laboratory Precision With-in laboratory precision for AmpliVue® Trichomonas Assay was determined via a study, where a four-member panel (3x LoD (Moderate positive), 1x LoD (Low positive), 1/9x LoD (High negative, C20 to C80), and a negative sample) was tested at one site in a random manner by two operators, three samples per concentration, twice a day for 12 days. All negative samples generated negative results for T. vaginalis. The percent agreement with positive results for High negative samples is 39% (within the target range of 20 to 80%). A 100% agreement was observed with expected results for Low positive and Moderate positive samples. 6 Concentration Operator #1 Operator #2 Overall Percent Agreement 95% Confidence Interval #expected results/# tested % Agreement 95% Confidence Interval #expected results/# tested % Agreement 95% Confidence Interval High Negative* (34 trophozoites /mL) 11/36 31% 18.0% to 46.9% 17/36 47% 32.0% to 63.0% 28/72 39% 28.5% to 50.4% Low Positive (307 trophozoites /mL) 36/36 100% 90.4% to 100 Product code:
idK143329_s0_e2000	K143329.txt	panel	83 - Microbiology	k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K143329 B. Purpose for Submission: To obtain clearance for a new device, Amplivue® Trichomonas Assay C. Measurand: A conserved multi-copy sequence of Trichomonas vaginalis genomic DNA D. Type of Test: Nucleic acid amplification assay (Helicase-dependent Amplification, HDA) E. Applicant: Quidel Corporation F. Proprietary and Established Names: Amplivue® Trichomonas Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.3860 2. Classification: Class II 3. Product code: OUY - Trichomonas vaginalis nucleic acid amplification test system 4. Panel: 83 - Microbiology 2 H. Intended Use: 1. Intended use(s): The AmpliVue® Trichomonas Assay is an in vitro diagnostic test, uses isothermal amplification technology (helicase-dependent amplification, HDA) for the qualitative detection of Trichomonas vaginalis nucleic acids isolated from clinician-collected vaginal swab specimens obtained from symptomatic or asymptomatic females to aid in the diagnosis of trichomoniasis. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: None I. Device Description: The AmpliVue® Trichomonas Assay is a self-contained disposable amplicon detection device that uses an isothermal amplification technology named Helicase-Dependent Amplification (HDA) for the detection of Trichomonas vaginalis in clinician-collected vaginal swabs from symptomatic and asymptomatic women. The assay targets a conserved multi-copy sequence of the T. vaginalis genomic DNA. The vaginal swab is eluted in a lysis tube, and the cells are lysed by heat treatment. After heat treatment, an aliquot of the lysed specimen is transferred into a dilution tube. An aliquot of this diluted sample is then added to a reaction tube containing a lyophilized mix of HDA reagents including primers specific for the amplification of a conserved DNA sequence only found in T. vaginalis. The assay includes an internal control for monitoring the integrity of the assay reagents and detection cassette as well as for monitoring HDA-inhibitors that may be present within the clinical specimens. The HDA reaction is asymmetric generating an excess of single-stranded DNA amplicons. The sequence specific capture probes as well as a biotinylated detection probe shared by both target and internal control bind to the corresponding single-stranded amplicons, forming dual labeled probe-amplicon hybrid. After completion of the HDA reaction, the reaction tube is transferred to a cassette for rapid detection and test result display. The dual-labeled probe-amplicon hybrid is detected by the lateral flow strip within the cassette. The bottom line captures the T. vaginalis amplicon and the top line captures the control amplicon. The biotin label binds the streptavidin-conjugated color particles for visualization and the test result is shown as a visible colored lines. 3 The cassette is comprised of two individual components: an amplicon cartridge that holds the running buffer and a single 0.2 mL thin wall reaction tube containing the amplified product; and the detection chamber which houses the amplicon cartridge and a vertical-flow DNA detection strip embedded into the cassette. The DNA detection strip is coated with different anti-hapten antibodies that serve as the T. vaginalis test (T) line and the control (C) line in the assay. A razor blade and a plastic pin located at the bottom of the detection chamber open the HDA reaction tube and the running buffer bulb when the handle of the cassette is closed. The mixture flows through a fiberglass paper connected to the DNA detection strip containing a fiberglass pad pre-loaded with streptavidin-conjugated color particles for color visualization. Detection of T. vaginalis DNA is reported whenever the T2 (Test line 2) is visible through the detection window of the cassette. The presence of T1 line is an invalid result for this assay and the test should be repeated with the lysed specimen. The presence of the C line is not required for positive results. No detection of T. vaginalis DNA is reported when only the C line is displayed. The assay is regarded as invalid when neither line is displayed. J. Substantial Equivalence Information: 1. Predicate device name(s): APTIMA Trichomonas vaginalis Assay (PANTHER® System) 2. Predicate 510(k) number(s): K122062 4 3. Comparison with predicate: Similarities Item Device AmpliVue® Trichomonas Assay Predicate APTIMA Trichomonas vaginalis Assay (PANTHER® System) (K122062) Intended Use The AmpliVue® Trichomonas Assay is an in vitro diagnostic test, uses isothermal amplification technology (helicase-dependent amplification, HDA) for the qualitative detection of Trichomonas vaginalis nucleic acids isolated from clinician- collected vaginal swab specimens obtained from symptomatic or asymptomatic females to aid in the diagnosis of trichomoniasis. The APTIMA Trichomonas vaginalis Assay is an in vitro qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the PANTHER System. The assay may be used to test the following specimens from symptomatic or asymptomatic women: clinician-collected endocervical swabs, clinician- collected vaginal swabs, and specimens collected in PreservCyt Solution. Assay Results Qualitative Qualitative Differences Item Device AmpliVue® Trichomonas Assay Predicate APTIMA Trichomonas vaginalis Assay (PANTHER® System) (K122062) Sample Types Clinician-collected Vaginal Swabs Clinician-collected Vaginal Swabs, Endocervical Swabs, ThinPrep in PreservCyt solution Target Sequence Detected Repeated DNA fragment located in T. vaginalis genome T. vaginalis ribosomal RNA (rRNA) Amplification Technology Helicase-dependent amplification (HDA) Transcription Mediated Amplification (TMA) Hybridization Protection Assay (HPA) Self-Contained System Assay after sample preparation No Yes Detection Technique Manual Automated Instrument None PANTHER System 5 K. Standard/Guidance Document Referenced (if applicable): None L. Test Principle: The AmpliVue® Trichomonas Assay uses HAD to detect T. vaginalis genomic DNA in vaginal swab specimens. The vaginal swab is eluted in a lysis tube, and the cells are lysed by heat treatment. An aliquot of the lysed specimen is transferred into a dilution tube which is then added to a reaction tube containing a lyophilized mix of HDA reagents including primers specific for the amplification of a conserved DNA sequence of T. vaginalis. The reaction tube also includes an internal control to confirm the integrity of the assay reagents and cassette detection as well as to monitor for HDA-inhibitors that may be present within the clinical specimens. The sequence specific capture probes as well as a biotinylated detection probe are shared by T. vaginalis target sequences and the internal control bind to the corresponding single-stranded amplicons (product of HDA reaction), forming a dual labeled probe-amplicon hybrid. After completion of the HDA reaction, the reaction tube is transferred to a cassette for rapid detection. The test result is displayed in the window of the cassette as test and/or control colored lines visible to the naked eye. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: With-in laboratory Precision With-in laboratory precision for AmpliVue® Trichomonas Assay was determined via a study, where a four-member panel (3x LoD (Moderate positive), 1x LoD (Low positive), 1/9x LoD (High negative, C20 to C80), and a negative sample) was tested at one site in a random manner by two operators, three samples per concentration, twice a day for 12 days. All negative samples generated negative results for T. vaginalis. The percent agreement with positive results for High negative samples is 39% (within the target range of 20 to 80%). A 100% agreement was observed with expected results for Low positive and Moderate positive samples. 6 Concentration Operator #1 Operator #2 Overall Percent Agreement 95% Confidence Interval #expected results/# tested % Agreement 95% Confidence Interval #expected results/# tested % Agreement 95% Confidence Interval High Negative* (34 trophozoites /mL) 11/36 31% 18.0% to 46.9% 17/36 47% 32.0% to 63.0% 28/72 39% 28.5% to 50.4% Low Positive (307 trophozoites /mL) 36/36 100% 90.4% to 100 Panel:
idK143329_s0_e2000	K143329.txt	intended use	The AmpliVue® Trichomonas Assay is an in vitro diagnostic test, uses isothermal amplification technology (helicase-dependent amplification, HDA) for the qualitative detection of Trichomonas vaginalis nucleic acids isolated from clinician-collected vaginal swab specimens obtained from symptomatic or asymptomatic females to aid in the diagnosis of trichomoniasis.	SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K143329 B. Purpose for Submission: To obtain clearance for a new device, Amplivue® Trichomonas Assay C. Measurand: A conserved multi-copy sequence of Trichomonas vaginalis genomic DNA D. Type of Test: Nucleic acid amplification assay (Helicase-dependent Amplification, HDA) E. Applicant: Quidel Corporation F. Proprietary and Established Names: Amplivue® Trichomonas Assay G. Regulatory Information: 1. Regulation section: 21 CFR 866.3860 2. Classification: Class II 3. Product code: OUY - Trichomonas vaginalis nucleic acid amplification test system 4. Panel: 83 - Microbiology 2 H. Intended Use: 1. Intended use(s): The AmpliVue® Trichomonas Assay is an in vitro diagnostic test, uses isothermal amplification technology (helicase-dependent amplification, HDA) for the qualitative detection of Trichomonas vaginalis nucleic acids isolated from clinician-collected vaginal swab specimens obtained from symptomatic or asymptomatic females to aid in the diagnosis of trichomoniasis. 2. Indication(s) for use: Same as Intended Use 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: None I. Device Description: The AmpliVue® Trichomonas Assay is a self-contained disposable amplicon detection device that uses an isothermal amplification technology named Helicase-Dependent Amplification (HDA) for the detection of Trichomonas vaginalis in clinician-collected vaginal swabs from symptomatic and asymptomatic women. The assay targets a conserved multi-copy sequence of the T. vaginalis genomic DNA. The vaginal swab is eluted in a lysis tube, and the cells are lysed by heat treatment. After heat treatment, an aliquot of the lysed specimen is transferred into a dilution tube. An aliquot of this diluted sample is then added to a reaction tube containing a lyophilized mix of HDA reagents including primers specific for the amplification of a conserved DNA sequence only found in T. vaginalis. The assay includes an internal control for monitoring the integrity of the assay reagents and detection cassette as well as for monitoring HDA-inhibitors that may be present within the clinical specimens. The HDA reaction is asymmetric generating an excess of single-stranded DNA amplicons. The sequence specific capture probes as well as a biotinylated detection probe shared by both target and internal control bind to the corresponding single-stranded amplicons, forming dual labeled probe-amplicon hybrid. After completion of the HDA reaction, the reaction tube is transferred to a cassette for rapid detection and test result display. The dual-labeled probe-amplicon hybrid is detected by the lateral flow strip within the cassette. The bottom line captures the T. vaginalis amplicon and the top line captures the control amplicon. The biotin label binds the streptavidin-conjugated color particles for visualization and the test result is shown as a visible colored lines. 3 The cassette is comprised of two individual components: an amplicon cartridge that holds the running buffer and a single 0.2 mL thin wall reaction tube containing the amplified product; and the detection chamber which houses the amplicon cartridge and a vertical-flow DNA detection strip embedded into the cassette. The DNA detection strip is coated with different anti-hapten antibodies that serve as the T. vaginalis test (T) line and the control (C) line in the assay. A razor blade and a plastic pin located at the bottom of the detection chamber open the HDA reaction tube and the running buffer bulb when the handle of the cassette is closed. The mixture flows through a fiberglass paper connected to the DNA detection strip containing a fiberglass pad pre-loaded with streptavidin-conjugated color particles for color visualization. Detection of T. vaginalis DNA is reported whenever the T2 (Test line 2) is visible through the detection window of the cassette. The presence of T1 line is an invalid result for this assay and the test should be repeated with the lysed specimen. The presence of the C line is not required for positive results. No detection of T. vaginalis DNA is reported when only the C line is displayed. The assay is regarded as invalid when neither line is displayed. J. Substantial Equivalence Information: 1. Predicate device name(s): APTIMA Trichomonas vaginalis Assay (PANTHER® System) 2. Predicate 510(k) number(s): K122062 4 3. Comparison with predicate: Similarities Item Device AmpliVue® Trichomonas Assay Predicate APTIMA Trichomonas vaginalis Assay (PANTHER® System) (K122062) Intended Use The AmpliVue® Trichomonas Assay is an in vitro diagnostic test, uses isothermal amplification technology (helicase-dependent amplification, HDA) for the qualitative detection of Trichomonas vaginalis nucleic acids isolated from clinician- collected vaginal swab specimens obtained from symptomatic or asymptomatic females to aid in the diagnosis of trichomoniasis. The APTIMA Trichomonas vaginalis Assay is an in vitro qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the PANTHER System. The assay may be used to test the following specimens from symptomatic or asymptomatic women: clinician-collected endocervical swabs, clinician- collected vaginal swabs, and specimens collected in PreservCyt Solution. Assay Results Qualitative Qualitative Differences Item Device AmpliVue® Trichomonas Assay Predicate APTIMA Trichomonas vaginalis Assay (PANTHER® System) (K122062) Sample Types Clinician-collected Vaginal Swabs Clinician-collected Vaginal Swabs, Endocervical Swabs, ThinPrep in PreservCyt solution Target Sequence Detected Repeated DNA fragment located in T. vaginalis genome T. vaginalis ribosomal RNA (rRNA) Amplification Technology Helicase-dependent amplification (HDA) Transcription Mediated Amplification (TMA) Hybridization Protection Assay (HPA) Self-Contained System Assay after sample preparation No Yes Detection Technique Manual Automated Instrument None PANTHER System 5 K. Standard/Guidance Document Referenced (if applicable): None L. Test Principle: The AmpliVue® Trichomonas Assay uses HAD to detect T. vaginalis genomic DNA in vaginal swab specimens. The vaginal swab is eluted in a lysis tube, and the cells are lysed by heat treatment. An aliquot of the lysed specimen is transferred into a dilution tube which is then added to a reaction tube containing a lyophilized mix of HDA reagents including primers specific for the amplification of a conserved DNA sequence of T. vaginalis. The reaction tube also includes an internal control to confirm the integrity of the assay reagents and cassette detection as well as to monitor for HDA-inhibitors that may be present within the clinical specimens. The sequence specific capture probes as well as a biotinylated detection probe are shared by T. vaginalis target sequences and the internal control bind to the corresponding single-stranded amplicons (product of HDA reaction), forming a dual labeled probe-amplicon hybrid. After completion of the HDA reaction, the reaction tube is transferred to a cassette for rapid detection. The test result is displayed in the window of the cassette as test and/or control colored lines visible to the naked eye. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: With-in laboratory Precision With-in laboratory precision for AmpliVue® Trichomonas Assay was determined via a study, where a four-member panel (3x LoD (Moderate positive), 1x LoD (Low positive), 1/9x LoD (High negative, C20 to C80), and a negative sample) was tested at one site in a random manner by two operators, three samples per concentration, twice a day for 12 days. All negative samples generated negative results for T. vaginalis. The percent agreement with positive results for High negative samples is 39% (within the target range of 20 to 80%). A 100% agreement was observed with expected results for Low positive and Moderate positive samples. 6 Concentration Operator #1 Operator #2 Overall Percent Agreement 95% Confidence Interval #expected results/# tested % Agreement 95% Confidence Interval #expected results/# tested % Agreement 95% Confidence Interval High Negative* (34 trophozoites /mL) 11/36 31% 18.0% to 46.9% 17/36 47% 32.0% to 63.0% 28/72 39% 28.5% to 50.4% Low Positive (307 trophozoites /mL) 36/36 100% 90.4% to 100 Intended use: