ODW — Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System Class II
Classification Details
- Product Code
- ODW
- Device Class
- Class II
- Regulation Number
- 862.3360
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Definition
An in vitro diagnostic assay for use in genotyping Cytochrome P450 2C9 (CYP450 2C9) alleles. Information about the CYP2C9 genotype may be used as an aid to clinicians in determining therapeutic strategy for medications that are metabolized by the CYP2C9 gene product.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K183530 | akonni biosystems | TruDiagnosis System | May 24, 2019 |
| K152612 | genmark diagnostics, incorporated | eSensor Warfarin Sensitivity Saliva Test | May 26, 2016 |
| K073071 | trimgen corporation | EQ-PRC LC WARFARIN GENOTYPING KIT | February 6, 2009 |
| K073720 | osmetech molecular diagnostics | ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT | July 17, 2008 |
| K073014 | autogenomics, incorporated | INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN | January 23, 2008 |
| K070804 | nanosphere | VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST | September 17, 2007 |