NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.
Dahabreh IJ, Moorthy D, Lamont JL, et al. Testing of CYP2C19 Variants and Platelet Reactivity for Guiding Antiplatelet Treatment [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2013 Sep. (Comparative Effectiveness Reviews, No. 125.)
Testing of CYP2C19 Variants and Platelet Reactivity for Guiding Antiplatelet Treatment [Internet].
Show detailsThe following documents from the U.S. Food and Drug administration were reviewed for this report. They were identified though a search of the database of the 510(k) Database† (1996–current) using the following stem or key words: aggreg*, PFA*, Ultegra*, Impact*, VerifyNow*, platelet*, plateletwork*, CY2C19, *2C19*, CYP2*, VASP*.
Appendix Table C1U.S. Food and Drug Administration documents reviewed: type of testing, test name, and comments
| Document | Test name | Comments |
|---|---|---|
| Genetic testing | ||
| K101683 | INFINITI CYP2C19 Assay | Population not described so document not included; however, indirect data given on limits of detection, sequencing concordance, and interlaboratory reproducibility. |
| K042259 | Roche AmpliChip CYP450 Test | Gene not of interest (CYPCD6). |
| K043576 | Amplichip CYP450 Test for CYP2C19 | Population not described so document not included; however, indirect data given on limits of detection, sensitivity and specificity, sequencing concordance, interassay agreement, comparison with a reference standard, cross-contamination, and reproducibility. |
| K012966 | COBAS TaqMan Analyzer | Population not described so document not included; however, indirect data given on the dynamic range, limits of detection, sensitivity, and specificity. |
| Phenotypic testing | ||
| K992531 | Accumetrics Ultegra System Rapid Platelet Function Assay-TRAP | Population is of interest (patients undergoing PCI [also treated with abciximab]) and reports interassay correlation. However, antiplatelet agents other than abciximab were not reported. |
| K011337 | Accumetrics Ultegra System Rapid Platelet Function Assay-TRAP | Population is of interest (patients undergoing PCI [also treated with abciximab]) and reports interassay correlation. However, antiplatelet agents other than abciximab were not reported. |
| K012701 | Accumetrics Ultegra System Rapid Platelet Function Assay-ASA | Test not of interest (measuring response to aspirin) |
| K013596 | Accumetrics Ultegra System Rapid Platelet Function Assay | Population is of interest (patients undergoing PCI [also treated with abciximab or eptifibatide]) and reports interassay correlation. However, antiplatelet agents other than abciximab or eptifibatide were not reported.. |
| K060489 | Dade PFA-100 Platelet Function Analyzer Dade PFA-100 Reagents | Populations not of interest (data summarized from studies in children and in patients with bleeding disorders) |
| K970505 | Dade PFA-100 Platelet Function Analyzer Dade PFA Collagen/Epinephrine Test Cartridge Dade PFA Collagen/ADP Test Cartridge Dade PFA Trigger Solution | Collagen/epinephrine test not of interest. For collagen/ADP test, populations not of interest (data summarized from a study of subjects with normal platelet function or paitients with von Willebrand disease, aspirin-induced dysfunction, or Glanzmann's thromasthenia) |
| K002885 | Dade PFA-100 Platelet Function Analyzer Dade PFA Collagen/Epinephrine Test Cartridge Dade PFA Collagen/ADP Test Cartridge Dade PFA Trigger Solution | Collagen/epinephrine test not of interest. For collagen/ADP test, populations not of interest (data summarized from studies of healthy children, healthy adults, and children with von Willebrand disease)) |
| K042423 | Accumetrics VerifyNow-Aspirin Assay | Test not of interest (measuring response to aspirin) |
| K051231 | Accumetrics VerifyNow P2Y12 Assay | Population is of interest (patients treated with clopidogrel with a history of vascular disease or risk factors) but n=10 only. |
| K093626 | INNOVANCE D-Dimer Assay | Population not of interest (patients presenting to emergency department with suspected deep-vein thrombosis) |
| K990398 | Plateletworks Platelet Aggregation Assay | Population not of interest (includes healthy volunteers) |
| K012723 | Collagen for Plateletworks | No data available (only approval statement is in database) |
| K023761 | Plateletworks | No data available (only approval statement is in database) |
| K061991 | Plateletworks Arachidonic Acid | Test not of interest (measuring response to arachidonic acid) |
| K032951 | Chrono-log Whole Blood Aggregometer, Model 591A/592A | Population not of interest (“normal, healthy, drug free subjects” or “normal donors and patients known to have von Willebrands Disease”) |
| K050265 | Model 700 Chrono-log Whole Blood Lumi-Aggregometer | Population not of interest (“normal, healthy, drug free subjects”) |
| K830749 | Chrono-log Model 560 Whole Blood Lumi-Aggregometer | No data available (no downloadable information in database) |
| K851025 | AGGRO/LINK Interface | No data available (no downloadable information in database) |
| K962426 | Chrono-log Whole Blood Aggregometer, Model 591/592 | No data available (only one-page summary is in database) |
| K954997 | Centocor Aggrestat, Collagen Reagent, Control Reagent | No data available (no downloadable information in database) |
Footnotes
- †
Available at http://www
.accessdata .fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn .cfm; last accessed: April 25, 2012. ASA=acetylsalicylic acid (aspirin), RPFA=rapid platelet function assay, TRAP=thrombin receptor activating peptide.
- U.S. Food and Drug Administration Documents Reviewed - Testing of CYP2C19 Varian...U.S. Food and Drug Administration Documents Reviewed - Testing of CYP2C19 Variants and Platelet Reactivity for Guiding Antiplatelet Treatment
- Exact Search Strings - Stroke Prevention in Patients With Atrial Fibrillation: A...Exact Search Strings - Stroke Prevention in Patients With Atrial Fibrillation: A Systematic Review Update
- Expert Guidance and Review - ADHD Diagnosis and Treatment in Children and Adoles...Expert Guidance and Review - ADHD Diagnosis and Treatment in Children and Adolescents
- Acknowledgments - Testing of CYP2C19 Variants and Platelet Reactivity for Guidin...Acknowledgments - Testing of CYP2C19 Variants and Platelet Reactivity for Guiding Antiplatelet Treatment
- Analytical Framework - Nonsurgical Treatments for Urinary Incontinence in Adult ...Analytical Framework - Nonsurgical Treatments for Urinary Incontinence in Adult Women: Diagnosis and Comparative Effectiveness
Your browsing activity is empty.
Activity recording is turned off.
See more...