OVK — Cytokeratin Fragments 21-1 Eia Kit Class II
FDA product code OVK covers "Cytokeratin Fragments 21-1 Eia Kit", a Class II medical device regulated under 21 CFR 866.6010. Submissions are reviewed by the Immunology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OVK
- Device Class
- Class II
- Regulation Number
- 866.6010
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250925 | fujirebio diagnostics | ADVIA Centaur Cytokeratin Fragment 21-1 | December 16, 2025 |
| K160915 | roche diagnostics | Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker | December 14, 2016 |
| K100831 | fujirebio diagnostics | CYFRA 21-1 EIA MODEL 211-10 | May 26, 2011 |