FDA product code OVK: Cytokeratin Fragments 21-1 Eia Kit
OVK is the FDA product code for cytokeratin fragments 21-1 eia kit. It is a Class II device, regulated under 21 CFR 866.6010 and reviewed by the Immunology panel. FDA has cleared 3 510(k) submissions under OVK, 1 in the last five years, from 2 different applicants. The average 510(k) review took 316 days (median 264); 264 days on average over the last three years.
Definition
The CYFRA 21-1 EIA kit is intended for the quantitative determination of soluble cytokeratin 19 fragments in human serum. The assay is to be used as an aid in monitoring disease progression during the course of disease and treatment in lung cancer patients. Serial testing for patient CYFRA 21-1 assay values should be used in conjunction with other clinical methods used for monitoring lung cancer.
Classification
| Field | Value |
|---|---|
| Device name | Cytokeratin Fragments 21-1 Eia Kit |
| Device class | Class II |
| Regulation | 21 CFR 866.6010 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for OVK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 264 |
Compare with all 510(k) review times · Search every OVK clearance
Top OVK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fujirebio Diagnostics,Inc. | 2 | 2025-12-16 |
| Roche Diagnostics | 1 | 2016-12-14 |
Most recent OVK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250925 | Fujirebio Diagnostics,Inc. | ADVIA Centaur Cytokeratin Fragment 21-1 | 2025-12-16 | 264 |
| K160915 | Roche Diagnostics | Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker | 2016-12-14 | 257 |
| K100831 | Fujirebio Diagnostics,Inc. | CYFRA 21-1 EIA MODEL 211-10 | 2011-05-26 | 428 |
Recalls for OVK devices
openFDA lists no recalls for product code OVK.
Frequently asked questions
What is FDA product code OVK?
OVK is the FDA product code for cytokeratin fragments 21-1 eia kit. It is a Class II device, regulated under 21 CFR 866.6010 and reviewed by the Immunology panel.
What device class is OVK?
Class II, regulation 21 CFR 866.6010. Typical premarket route: 510(k).
How long does a 510(k) take for product code OVK?
Across 3 cleared submissions the average was 316 days from receipt to decision (median 264).
Which companies have the most OVK clearances?
Fujirebio Diagnostics,Inc. (2); Roche Diagnostics (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OVK
- Run a recall and safety report across every OVK manufacturer
- Watch product code OVK 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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