FDA product code ODV: Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System
ODV is the FDA product code for vitamin k epoxide reductase complex subunit one (vkorc1) genotyping system. It is a Class II device, regulated under 21 CFR 864.7750 and reviewed by the Hematology panel. FDA has cleared 1 510(k) submission under ODV. The average 510(k) review took 297 days (median 297).
Definition
An in vitro diagnostic assay for use in genotyping vitamin k epoxide reductase complex subunit one (VKORC1) alleles to aid in the identification of patients at risk for altered warfarin sensitivity.
Classification
| Field | Value |
|---|---|
| Device name | Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System |
| Device class | Class II |
| Regulation | 21 CFR 864.7750 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every ODV clearance
Top ODV applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Paragondx, LLC | 1 | 2008-04-28 |
Most recent ODV clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K071867 | Paragondx, LLC | RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA | 2008-04-28 | 297 |
Recalls for ODV devices
openFDA lists no recalls for product code ODV.
Frequently asked questions
What is FDA product code ODV?
ODV is the FDA product code for vitamin k epoxide reductase complex subunit one (vkorc1) genotyping system. It is a Class II device, regulated under 21 CFR 864.7750 and reviewed by the Hematology panel.
What device class is ODV?
Class II, regulation 21 CFR 864.7750. Typical premarket route: 510(k).
How long does a 510(k) take for product code ODV?
Across 1 cleared submissions the average was 297 days from receipt to decision (median 297).
Which companies have the most ODV clearances?
Paragondx, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ODV
- Run a recall and safety report across every ODV manufacturer
- Watch product code ODV 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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