FDA product code ODW: Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
ODW is the FDA product code for cytochrome p450 2c9 (cyp450 2c9) drug metabolizing enzyme genotyping system. It is a Class II device, regulated under 21 CFR 862.3360 and reviewed by the Clinical Toxicology panel. FDA has cleared 6 510(k) submissions under ODW, from 6 different applicants. The average 510(k) review took 224 days (median 188). FDA has posted 1 recall for ODW devices.
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.
Classification
| Field | Value |
|---|---|
| Device name | Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System |
| Device class | Class II |
| Regulation | 21 CFR 862.3360 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for ODW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 156 |
Compare with all 510(k) review times · Search every ODW clearance
Top ODW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Akonni Biosystems, Inc. | 1 | 2019-05-24 |
| Genmark Diagnostics, Incorporated | 1 | 2016-05-26 |
| Trimgen Corporation | 1 | 2009-02-06 |
| Osmetech Molecular Diagnostics | 1 | 2008-07-17 |
| Autogenomics, Incorporated | 1 | 2008-01-23 |
1 more applicants have ODW clearances. See the full list in Caduvo.
Most recent ODW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K183530 | Akonni Biosystems, Inc. | TruDiagnosis System | 2019-05-24 | 156 |
| K152612 | Genmark Diagnostics, Incorporated | eSensor Warfarin Sensitivity Saliva Test | 2016-05-26 | 255 |
| K073071 | Trimgen Corporation | EQ-PRC LC WARFARIN GENOTYPING KIT | 2009-02-06 | 464 |
| K073720 | Osmetech Molecular Diagnostics | ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT | 2008-07-17 | 199 |
| K073014 | Autogenomics, Incorporated | INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN | 2008-01-23 | 90 |
Recalls for ODW devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2008-02-25.
Frequently asked questions
What is FDA product code ODW?
ODW is the FDA product code for cytochrome p450 2c9 (cyp450 2c9) drug metabolizing enzyme genotyping system. It is a Class II device, regulated under 21 CFR 862.3360 and reviewed by the Clinical Toxicology panel.
What device class is ODW?
Class II, regulation 21 CFR 862.3360. Typical premarket route: 510(k).
How long does a 510(k) take for product code ODW?
Across 6 cleared submissions the average was 224 days from receipt to decision (median 188).
Which companies have the most ODW clearances?
Akonni Biosystems, Inc. (1); Genmark Diagnostics, Incorporated (1); Trimgen Corporation (1); Osmetech Molecular Diagnostics (1); Autogenomics, Incorporated (1).
Have ODW devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2008-02-25.
Next steps
- Run an FDA pathway report with predicate devices for product code ODW
- Run a recall and safety report across every ODW manufacturer
- Watch product code ODW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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