# OVK: Cytokeratin Fragments 21-1 Eia Kit

- Device class: 2; regulation: 21 CFR 866.6010; FDA's rule: 510(k) required
- FDA decisions: 3
- 510(k) review time 2021–2025: median 264 days (middle half 264–264)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2011: 1
- 2016: 1
- 2025: 1

## Most-cited predicates
- K100831: Cyfra 21-1 Eia Model 211-10 (2011), cited by 2
- K160915: Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker (2016), cited by 1

Source page: https://510kreport.com/product-code/OVK
Data by year (CSV): https://510kreport.com/product-code/OVK.csv