OVK · Cytokeratin Fragments 21-1 Eia Kit
Immunology · 21 CFR 866.6010 · Class 2
Overview
| Product Code | OVK |
|---|---|
| Device Name | Cytokeratin Fragments 21-1 Eia Kit |
| Regulation | 21 CFR 866.6010 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
Identification
A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.
Classification Rationale
Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.
Special Controls
*Classification.* Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250925 | ADVIA Centaur Cytokeratin Fragment 21-1 | Fujirebio Diagnostics,Inc. | Dec 16, 2025 | SESE |
| K160915 | Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker | Roche Diagnostics | Dec 14, 2016 | SESE |
| K100831 | CYFRA 21-1 EIA MODEL 211-10 | Fujirebio Diagnostics,Inc. | May 26, 2011 | SESE |
Top Applicants
- Fujirebio Diagnostics,Inc. — 2 clearances
- Roche Diagnostics — 1 clearance
