510(k) K250925
K250925 is an FDA 510(k) premarket notification submitted by Fujirebio Diagnostics,Inc. for the device "ADVIA Centaur Cytokeratin Fragment 21-1". The FDA issued a decision of Substantially Equivalent on December 16, 2025. The device falls under product code OVK (Cytokeratin Fragments 21-1 Eia Kit), a Class II device regulated under 21 CFR 866.6010. Fujirebio Diagnostics,Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 16, 2025
- Date Received
- March 27, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cytokeratin Fragments 21-1 Eia Kit
- Device Class
- Class II
- Regulation Number
- 866.6010
- Review Panel
- IM
- Submission Type
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.