# K100831: Cyfra 21-1 Eia Model 211-10

- Pathway: 510(k) (Traditional)
- Applicant: Fujirebio Diagnostics,Inc.
- Decided: May 26, 2011 after 428 days
- Product code: OVK (Cytokeratin Fragments 21-1 Eia Kit)
- Device class: 2
- Regulation: 21 CFR 866.6010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K990774 (1999). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990774: Abbott Architect Cea, Abbott Laboratories (1999) Summary page 1.

## Most influential descendants
- K160915: Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker (2016), 1 descendant of its own
- K250925: ADVIA Centaur Cytokeratin Fragment 21-1 (2025), 0 descendants of its own
- K202852: DiviTum TKa (2022), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K100831
Methodology: https://510kreport.com/methodology