Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
The Cytochrome P450 2C9 (CYP450 2C9) Drug Metabolizing Enzyme Genotyping System (product code ODW) is a clinical toxicology in vitro diagnostic assay used to genotype CYP2C9 alleles, providing information to aid clinicians in determining therapeutic strategy for medications metabolized by the CYP2C9 enzyme, including warfarin and certain NSAIDs. CYP2C9 genotype influences drug metabolism rate and can predict adverse drug reactions or treatment failure. This device is FDA Class 2 under regulation 862.3360 in the Clinical Toxicology specialty, requires 510(k) clearance, and is eligible for third-party review. It carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- ODW
- Device Class
- FDA class 2
- Regulation Number
- 862.3360
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K183530 | TruDiagnosis System | May 24, 2019 | Substantially Equivalent | Akonni Biosystems, Inc. |
| K152612 | eSensor Warfarin Sensitivity Saliva Test | May 26, 2016 | Substantially Equivalent | Genmark Diagnostics, Incorporated |
| K073071 | EQ-PRC LC WARFARIN GENOTYPING KIT | Feb 06, 2009 | Substantially Equivalent | Trimgen Corporation |
| K073720 | ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT | Jul 17, 2008 | Substantially Equivalent | Osmetech Molecular Diagnostics |
| K073014 | INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN | Jan 23, 2008 | Substantially Equivalent | Autogenomics, Incorporated |
| K070804 | VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST | Sep 17, 2007 | Substantially Equivalent | Nanosphere, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.