# K143534: Elecsys CA-125 II assay

- Pathway: 510(k) (Traditional)
- Applicant: Roche Professional Diagnostics
- Decided: Aug 6, 2015 after 237 days
- Product code: LTK (Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125))
- 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: 6 generations back to K001015 (2000). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972162: Elecsys CA 125 II, Boehringer Mannheim Corp. (1998) Summary page 6.
- K102086: Elecsys CA 125 II Calcheck 5, Roche Diagnostics (2010) Summary page 6.

## Indications for use
Elecsys CA 125 II is an immunoassay for the in vitro quantitative determination of OC 125 reactive determinants in human serum, Li heparin, K2-EDTA and K3-EDTA, as well as Li-heparin plasma tubes containing separating gel on the cobas e 411 analyzer. These determinants are associated with a high molecular weight glycoprotein in serum and plasma of women with primary epithelial invasive ovarian cancer (excluding those with cancer of low malignant potential). This immunoassay is indicated for use as an aid in the detection of residual or recurrent ovarian carcinoma. This immunoassay is further indicated for use in monitoring patients for disease progress or response to therapy. The electrochemiluminescence immunoassay “ECLIA” is intended for use on the cobas e 411 immunoassay analyzers. For use in the verification of the calibration established by the Elecsys CA 125 II reagent on the Elecsys and cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K143534
Methodology: https://510kreport.com/methodology