Sample Prep:Article Title:
Article Snippet: .. Same Sample Preparation Genomic DNA extracted from blood Same Amplification Method Multiplex PCR Same Detection Method Fluorescence Based Same Target Gene CYP2C19 Same Results Qualitative Same Target Mutations *2, *3, *17 Same Differences Item Candidate Device: xTAG® CYP2C19 Kit v3 (k121958) Predicate Device: INFINITI CYP2C19 Assay (k101683) Specimen Type Genomic DNA from EDTA or citrate anticoagulated whole blood samples Genomic DNA from EDTA anticoagulated whole blood samples Test Principle Multiplex bead-based universal array sorting on the Luminex® 100/200TM or MAGPIX® system instrument Microarray comprised of a polyester film coated with proprietary multi-layer components designed for DNA analysis Instrument Luminex® 100/200TM or MAGPIX® system with xPONENT® software INFINITI Analyzer K. Standard/Guidance Document Referenced (if applicable): · CLSI MM13-A Collection, Transport, Preparation, and Storage of Specimens, 2005 · CLSI Guideline EP5-A2, Evaluation of Precision Performance of Quantitative Measurement Methods-2nd Ed., 2004 · CLSI Guideline EP7-A2, Interference Testing in Clinical Chemistry; Approved Guideline-2nd Ed., 2005 · CLSI EP12-A2 User Protocol for Evaluation of Qualitative Test Performance, 2008 · CLSI EP14-A2 Evaluation of Matrix Effects- 2nd Ed., 2005 · CLSI EP15-A2 User Verification of Performance for Precision and Trueness; Approved Guideline-2nd Ed., 2005 · CLSI EP17-A Protocol for Determination of Limit of Detection and Limits of Quantitation, 2004 · CEN 13649 Stability testing of In Vitro Diagnostic Reagents, 2002 · ISO 14971:2007 Medical devices-Application of risk management to medical devices 2007 · ISO 15223-1 Medical devices- Symbols to be used with medical device labels, labeling, and information to be supplied, 2007 · IEC 62304 Ed. ..
Amplification:Article Title:
Article Snippet: .. Same Sample Preparation Genomic DNA extracted from blood Same Amplification Method Multiplex PCR Same Detection Method Fluorescence Based Same Target Gene CYP2C19 Same Results Qualitative Same Target Mutations *2, *3, *17 Same Differences Item Candidate Device: xTAG® CYP2C19 Kit v3 (k121958) Predicate Device: INFINITI CYP2C19 Assay (k101683) Specimen Type Genomic DNA from EDTA or citrate anticoagulated whole blood samples Genomic DNA from EDTA anticoagulated whole blood samples Test Principle Multiplex bead-based universal array sorting on the Luminex® 100/200TM or MAGPIX® system instrument Microarray comprised of a polyester film coated with proprietary multi-layer components designed for DNA analysis Instrument Luminex® 100/200TM or MAGPIX® system with xPONENT® software INFINITI Analyzer K. Standard/Guidance Document Referenced (if applicable): · CLSI MM13-A Collection, Transport, Preparation, and Storage of Specimens, 2005 · CLSI Guideline EP5-A2, Evaluation of Precision Performance of Quantitative Measurement Methods-2nd Ed., 2004 · CLSI Guideline EP7-A2, Interference Testing in Clinical Chemistry; Approved Guideline-2nd Ed., 2005 · CLSI EP12-A2 User Protocol for Evaluation of Qualitative Test Performance, 2008 · CLSI EP14-A2 Evaluation of Matrix Effects- 2nd Ed., 2005 · CLSI EP15-A2 User Verification of Performance for Precision and Trueness; Approved Guideline-2nd Ed., 2005 · CLSI EP17-A Protocol for Determination of Limit of Detection and Limits of Quantitation, 2004 · CEN 13649 Stability testing of In Vitro Diagnostic Reagents, 2002 · ISO 14971:2007 Medical devices-Application of risk management to medical devices 2007 · ISO 15223-1 Medical devices- Symbols to be used with medical device labels, labeling, and information to be supplied, 2007 · IEC 62304 Ed. ..
Multiplex Assay:Article Title:
Article Snippet: .. Same Sample Preparation Genomic DNA extracted from blood Same Amplification Method Multiplex PCR Same Detection Method Fluorescence Based Same Target Gene CYP2C19 Same Results Qualitative Same Target Mutations *2, *3, *17 Same Differences Item Candidate Device: xTAG® CYP2C19 Kit v3 (k121958) Predicate Device: INFINITI CYP2C19 Assay (k101683) Specimen Type Genomic DNA from EDTA or citrate anticoagulated whole blood samples Genomic DNA from EDTA anticoagulated whole blood samples Test Principle Multiplex bead-based universal array sorting on the Luminex® 100/200TM or MAGPIX® system instrument Microarray comprised of a polyester film coated with proprietary multi-layer components designed for DNA analysis Instrument Luminex® 100/200TM or MAGPIX® system with xPONENT® software INFINITI Analyzer K. Standard/Guidance Document Referenced (if applicable): · CLSI MM13-A Collection, Transport, Preparation, and Storage of Specimens, 2005 · CLSI Guideline EP5-A2, Evaluation of Precision Performance of Quantitative Measurement Methods-2nd Ed., 2004 · CLSI Guideline EP7-A2, Interference Testing in Clinical Chemistry; Approved Guideline-2nd Ed., 2005 · CLSI EP12-A2 User Protocol for Evaluation of Qualitative Test Performance, 2008 · CLSI EP14-A2 Evaluation of Matrix Effects- 2nd Ed., 2005 · CLSI EP15-A2 User Verification of Performance for Precision and Trueness; Approved Guideline-2nd Ed., 2005 · CLSI EP17-A Protocol for Determination of Limit of Detection and Limits of Quantitation, 2004 · CEN 13649 Stability testing of In Vitro Diagnostic Reagents, 2002 · ISO 14971:2007 Medical devices-Application of risk management to medical devices 2007 · ISO 15223-1 Medical devices- Symbols to be used with medical device labels, labeling, and information to be supplied, 2007 · IEC 62304 Ed. ..
Polymerase Chain Reaction:Article Title:
Article Snippet: .. Same Sample Preparation Genomic DNA extracted from blood Same Amplification Method Multiplex PCR Same Detection Method Fluorescence Based Same Target Gene CYP2C19 Same Results Qualitative Same Target Mutations *2, *3, *17 Same Differences Item Candidate Device: xTAG® CYP2C19 Kit v3 (k121958) Predicate Device: INFINITI CYP2C19 Assay (k101683) Specimen Type Genomic DNA from EDTA or citrate anticoagulated whole blood samples Genomic DNA from EDTA anticoagulated whole blood samples Test Principle Multiplex bead-based universal array sorting on the Luminex® 100/200TM or MAGPIX® system instrument Microarray comprised of a polyester film coated with proprietary multi-layer components designed for DNA analysis Instrument Luminex® 100/200TM or MAGPIX® system with xPONENT® software INFINITI Analyzer K. Standard/Guidance Document Referenced (if applicable): · CLSI MM13-A Collection, Transport, Preparation, and Storage of Specimens, 2005 · CLSI Guideline EP5-A2, Evaluation of Precision Performance of Quantitative Measurement Methods-2nd Ed., 2004 · CLSI Guideline EP7-A2, Interference Testing in Clinical Chemistry; Approved Guideline-2nd Ed., 2005 · CLSI EP12-A2 User Protocol for Evaluation of Qualitative Test Performance, 2008 · CLSI EP14-A2 Evaluation of Matrix Effects- 2nd Ed., 2005 · CLSI EP15-A2 User Verification of Performance for Precision and Trueness; Approved Guideline-2nd Ed., 2005 · CLSI EP17-A Protocol for Determination of Limit of Detection and Limits of Quantitation, 2004 · CEN 13649 Stability testing of In Vitro Diagnostic Reagents, 2002 · ISO 14971:2007 Medical devices-Application of risk management to medical devices 2007 · ISO 15223-1 Medical devices- Symbols to be used with medical device labels, labeling, and information to be supplied, 2007 · IEC 62304 Ed. ..
Fluorescence:Article Title:
Article Snippet: .. Same Sample Preparation Genomic DNA extracted from blood Same Amplification Method Multiplex PCR Same Detection Method Fluorescence Based Same Target Gene CYP2C19 Same Results Qualitative Same Target Mutations *2, *3, *17 Same Differences Item Candidate Device: xTAG® CYP2C19 Kit v3 (k121958) Predicate Device: INFINITI CYP2C19 Assay (k101683) Specimen Type Genomic DNA from EDTA or citrate anticoagulated whole blood samples Genomic DNA from EDTA anticoagulated whole blood samples Test Principle Multiplex bead-based universal array sorting on the Luminex® 100/200TM or MAGPIX® system instrument Microarray comprised of a polyester film coated with proprietary multi-layer components designed for DNA analysis Instrument Luminex® 100/200TM or MAGPIX® system with xPONENT® software INFINITI Analyzer K. Standard/Guidance Document Referenced (if applicable): · CLSI MM13-A Collection, Transport, Preparation, and Storage of Specimens, 2005 · CLSI Guideline EP5-A2, Evaluation of Precision Performance of Quantitative Measurement Methods-2nd Ed., 2004 · CLSI Guideline EP7-A2, Interference Testing in Clinical Chemistry; Approved Guideline-2nd Ed., 2005 · CLSI EP12-A2 User Protocol for Evaluation of Qualitative Test Performance, 2008 · CLSI EP14-A2 Evaluation of Matrix Effects- 2nd Ed., 2005 · CLSI EP15-A2 User Verification of Performance for Precision and Trueness; Approved Guideline-2nd Ed., 2005 · CLSI EP17-A Protocol for Determination of Limit of Detection and Limits of Quantitation, 2004 · CEN 13649 Stability testing of In Vitro Diagnostic Reagents, 2002 · ISO 14971:2007 Medical devices-Application of risk management to medical devices 2007 · ISO 15223-1 Medical devices- Symbols to be used with medical device labels, labeling, and information to be supplied, 2007 · IEC 62304 Ed. ..
Microarray:Article Title:
Article Snippet: .. Same Sample Preparation Genomic DNA extracted from blood Same Amplification Method Multiplex PCR Same Detection Method Fluorescence Based Same Target Gene CYP2C19 Same Results Qualitative Same Target Mutations *2, *3, *17 Same Differences Item Candidate Device: xTAG® CYP2C19 Kit v3 (k121958) Predicate Device: INFINITI CYP2C19 Assay (k101683) Specimen Type Genomic DNA from EDTA or citrate anticoagulated whole blood samples Genomic DNA from EDTA anticoagulated whole blood samples Test Principle Multiplex bead-based universal array sorting on the Luminex® 100/200TM or MAGPIX® system instrument Microarray comprised of a polyester film coated with proprietary multi-layer components designed for DNA analysis Instrument Luminex® 100/200TM or MAGPIX® system with xPONENT® software INFINITI Analyzer K. Standard/Guidance Document Referenced (if applicable): · CLSI MM13-A Collection, Transport, Preparation, and Storage of Specimens, 2005 · CLSI Guideline EP5-A2, Evaluation of Precision Performance of Quantitative Measurement Methods-2nd Ed., 2004 · CLSI Guideline EP7-A2, Interference Testing in Clinical Chemistry; Approved Guideline-2nd Ed., 2005 · CLSI EP12-A2 User Protocol for Evaluation of Qualitative Test Performance, 2008 · CLSI EP14-A2 Evaluation of Matrix Effects- 2nd Ed., 2005 · CLSI EP15-A2 User Verification of Performance for Precision and Trueness; Approved Guideline-2nd Ed., 2005 · CLSI EP17-A Protocol for Determination of Limit of Detection and Limits of Quantitation, 2004 · CEN 13649 Stability testing of In Vitro Diagnostic Reagents, 2002 · ISO 14971:2007 Medical devices-Application of risk management to medical devices 2007 · ISO 15223-1 Medical devices- Symbols to be used with medical device labels, labeling, and information to be supplied, 2007 · IEC 62304 Ed. ..
Software:Article Title:
Article Snippet: .. Same Sample Preparation Genomic DNA extracted from blood Same Amplification Method Multiplex PCR Same Detection Method Fluorescence Based Same Target Gene CYP2C19 Same Results Qualitative Same Target Mutations *2, *3, *17 Same Differences Item Candidate Device: xTAG® CYP2C19 Kit v3 (k121958) Predicate Device: INFINITI CYP2C19 Assay (k101683) Specimen Type Genomic DNA from EDTA or citrate anticoagulated whole blood samples Genomic DNA from EDTA anticoagulated whole blood samples Test Principle Multiplex bead-based universal array sorting on the Luminex® 100/200TM or MAGPIX® system instrument Microarray comprised of a polyester film coated with proprietary multi-layer components designed for DNA analysis Instrument Luminex® 100/200TM or MAGPIX® system with xPONENT® software INFINITI Analyzer K. Standard/Guidance Document Referenced (if applicable): · CLSI MM13-A Collection, Transport, Preparation, and Storage of Specimens, 2005 · CLSI Guideline EP5-A2, Evaluation of Precision Performance of Quantitative Measurement Methods-2nd Ed., 2004 · CLSI Guideline EP7-A2, Interference Testing in Clinical Chemistry; Approved Guideline-2nd Ed., 2005 · CLSI EP12-A2 User Protocol for Evaluation of Qualitative Test Performance, 2008 · CLSI EP14-A2 Evaluation of Matrix Effects- 2nd Ed., 2005 · CLSI EP15-A2 User Verification of Performance for Precision and Trueness; Approved Guideline-2nd Ed., 2005 · CLSI EP17-A Protocol for Determination of Limit of Detection and Limits of Quantitation, 2004 · CEN 13649 Stability testing of In Vitro Diagnostic Reagents, 2002 · ISO 14971:2007 Medical devices-Application of risk management to medical devices 2007 · ISO 15223-1 Medical devices- Symbols to be used with medical device labels, labeling, and information to be supplied, 2007 · IEC 62304 Ed. ..
Quantitation Assay:Article Title:
Article Snippet: .. Same Sample Preparation Genomic DNA extracted from blood Same Amplification Method Multiplex PCR Same Detection Method Fluorescence Based Same Target Gene CYP2C19 Same Results Qualitative Same Target Mutations *2, *3, *17 Same Differences Item Candidate Device: xTAG® CYP2C19 Kit v3 (k121958) Predicate Device: INFINITI CYP2C19 Assay (k101683) Specimen Type Genomic DNA from EDTA or citrate anticoagulated whole blood samples Genomic DNA from EDTA anticoagulated whole blood samples Test Principle Multiplex bead-based universal array sorting on the Luminex® 100/200TM or MAGPIX® system instrument Microarray comprised of a polyester film coated with proprietary multi-layer components designed for DNA analysis Instrument Luminex® 100/200TM or MAGPIX® system with xPONENT® software INFINITI Analyzer K. Standard/Guidance Document Referenced (if applicable): · CLSI MM13-A Collection, Transport, Preparation, and Storage of Specimens, 2005 · CLSI Guideline EP5-A2, Evaluation of Precision Performance of Quantitative Measurement Methods-2nd Ed., 2004 · CLSI Guideline EP7-A2, Interference Testing in Clinical Chemistry; Approved Guideline-2nd Ed., 2005 · CLSI EP12-A2 User Protocol for Evaluation of Qualitative Test Performance, 2008 · CLSI EP14-A2 Evaluation of Matrix Effects- 2nd Ed., 2005 · CLSI EP15-A2 User Verification of Performance for Precision and Trueness; Approved Guideline-2nd Ed., 2005 · CLSI EP17-A Protocol for Determination of Limit of Detection and Limits of Quantitation, 2004 · CEN 13649 Stability testing of In Vitro Diagnostic Reagents, 2002 · ISO 14971:2007 Medical devices-Application of risk management to medical devices 2007 · ISO 15223-1 Medical devices- Symbols to be used with medical device labels, labeling, and information to be supplied, 2007 · IEC 62304 Ed. ..
Labeling:Article Title:
Article Snippet: .. Same Sample Preparation Genomic DNA extracted from blood Same Amplification Method Multiplex PCR Same Detection Method Fluorescence Based Same Target Gene CYP2C19 Same Results Qualitative Same Target Mutations *2, *3, *17 Same Differences Item Candidate Device: xTAG® CYP2C19 Kit v3 (k121958) Predicate Device: INFINITI CYP2C19 Assay (k101683) Specimen Type Genomic DNA from EDTA or citrate anticoagulated whole blood samples Genomic DNA from EDTA anticoagulated whole blood samples Test Principle Multiplex bead-based universal array sorting on the Luminex® 100/200TM or MAGPIX® system instrument Microarray comprised of a polyester film coated with proprietary multi-layer components designed for DNA analysis Instrument Luminex® 100/200TM or MAGPIX® system with xPONENT® software INFINITI Analyzer K. Standard/Guidance Document Referenced (if applicable): · CLSI MM13-A Collection, Transport, Preparation, and Storage of Specimens, 2005 · CLSI Guideline EP5-A2, Evaluation of Precision Performance of Quantitative Measurement Methods-2nd Ed., 2004 · CLSI Guideline EP7-A2, Interference Testing in Clinical Chemistry; Approved Guideline-2nd Ed., 2005 · CLSI EP12-A2 User Protocol for Evaluation of Qualitative Test Performance, 2008 · CLSI EP14-A2 Evaluation of Matrix Effects- 2nd Ed., 2005 · CLSI EP15-A2 User Verification of Performance for Precision and Trueness; Approved Guideline-2nd Ed., 2005 · CLSI EP17-A Protocol for Determination of Limit of Detection and Limits of Quantitation, 2004 · CEN 13649 Stability testing of In Vitro Diagnostic Reagents, 2002 · ISO 14971:2007 Medical devices-Application of risk management to medical devices 2007 · ISO 15223-1 Medical devices- Symbols to be used with medical device labels, labeling, and information to be supplied, 2007 · IEC 62304 Ed. ..
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