# K171605: Elecsys CA 15-3 II

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Feb 20, 2018 after 264 days
- Product code: MOI (System, Test, Immunological, Antigen, Tumor)
- 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 K001468 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001468: Elecsys CA 15-3 Test System, Roche Diagnostics Corp. (2000) Summary page 4.

## Most influential descendants
- K181492: Elecsys CA 15-3 II (2018), 0 descendants of its own

## Indications for use
Immunological in vitro assay for quantitative determination of CA 15‑3 in human serum and Li-heparin plasma to aid in the management of breast cancer patients. In conjunction with other clinical and diagnostic procedures, serial testing with this assay is an aid ▪ in the early detection of recurrence in previously treated stage II and III breast cancer patients ▪ for monitoring response to therapy in metastatic breast cancer patients The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K171605
Methodology: https://510kreport.com/methodology