# K981698: Acs:180 BR (Automated Chemiluminescence System for the Quantitation of Cancer Antigen 27.29)

- Pathway: 510(k) (Traditional)
- Applicant: Chiron Corp.
- Decided: Jul 10, 1998 after 57 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
No predicates in its family tree.
2 later devices descend 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)
- None. The FDA summary names its predicate without a number.
- (no number) ACS:180 BR: named in the summary without a submission number

## Most influential descendants
- K982680: Chiron Diagnostics Corporation Acs: Centaur BR Immunoassay (1998), 1 descendant of its own
- K193489: ADVIA Centaur BR (2020), 0 descendants of its own

## Indications for use
The 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 using the Chiron Diagnostics ACS:180® Automated Chemiluminescence Systems. The test is intended for use as an aid in monitoring patients previously treated for Stage Il or Stage [l breast cancer. Serial testing for CA 27.29 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also intended for use as an aid in the mamagement 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/K981698
Methodology: https://510kreport.com/methodology