# K160915: Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Dec 14, 2016 after 257 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: 5 generations back to K964020 (1997). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100831: Cyfra 21-1 Eia Model 211-10, Fujirebio Diagnostics,Inc. (2011) Summary page 6.
- K112624: Elecsys HE4, Elecsys HE4 Calset, Elecsys Precicontrol HE4, Elecsys HE4 Calcheck 5, Roche Diagnostics (2012) Summary page 8.
- K050387: Roche Diagnostics Elecsys Precicontrol Tumor, Roche Diagnostics Corp. (2005) Summary page 13.

## Most influential descendants
- K250925: ADVIA Centaur Cytokeratin Fragment 21-1 (2025), 0 descendants of its own

## Indications for use
Elecsys CYFRE 21-1: Immunoassay for the in vitro quantitative determination of fragments of cytokeratin 19 in human serum and plasma (Li-Heparin, K2-EDTA and K3-EDTA). 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. The electrochemiluminescence immunoassay “ECLIA” is intended for use on Elecsys and cobas e immunoassay analyzers. Elecsys CYFRA 21-1 CalSet: CYFRA 21-1 is used for calibrating the quantitative Elecsys CYFRA 21-1 assay on the Elecsys and cobas e immunoassay analyzers. Elecsys PreciControl Tumor Marker: PreciControl Tumor Marker is used for quality control of Elecsys immunoassays on Elecsys and cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K160915
Methodology: https://510kreport.com/methodology