# K181492: Elecsys CA 15-3 II

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Jun 22, 2018 after 16 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: 2 generations back to K001468 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171605: Elecsys CA 15-3 II, Roche Diagnostics (2018) Summary page 4.

## Indications for use
Immunological in vitro assay for quantitative determination of CA 15-3 in human serum, Li-heparin and EDTA 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/K181492
Methodology: https://510kreport.com/methodology