Cytokeratin Fragments 21-1 Eia Kit
The Cytokeratin Fragments 21-1 EIA Kit (product code OVK) is an enzyme immunoassay intended for the quantitative determination of soluble cytokeratin 19 fragments (CYFRA 21-1) in human serum. It is used as an aid in monitoring disease progression and treatment response in lung cancer patients, and serial testing should be used in conjunction with other clinical monitoring methods. As an FDA Class 2 device under regulation 866.6010, it requires 510(k) premarket clearance and falls within the Immunology specialty. The device is eligible for third-party review and is not an implant or life-sustaining device.
Basic Information
- Product Code
- OVK
- Device Class
- FDA class 2
- Regulation Number
- 866.6010
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K250925 | ADVIA Centaur Cytokeratin Fragment 21-1 | Dec 16, 2025 | Substantially Equivalent | Fujirebio Diagnostics,Inc. |
| K160915 | Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker | Dec 14, 2016 | Substantially Equivalent | Roche Diagnostics |
| K100831 | CYFRA 21-1 EIA MODEL 211-10 | May 26, 2011 | Substantially Equivalent | Fujirebio Diagnostics,Inc. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.