# K970695: Acs:180 BR (Automated Chemiluminescence System for the Quantitation of Cancer Antigen 27.29)

- Pathway: 510(k) (Traditional)
- Applicant: Chiron Diagnostics Corp.
- Decided: Aug 8, 1997 after 164 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 P950011 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P950011: Truquant (R) BR (TM) Ria, Biomira, Inc. (1996) Summary page 1.

## Indications for use
Chiron Diagnostics' ACS:180 BR is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum. The test is intended for use as an aid in the management of breast cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment.

Source page: https://510kreport.com/device/K970695
Methodology: https://510kreport.com/methodology