# K982680: Chiron Diagnostics Corporation Acs: Centaur BR Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Chiron Diagnostics Corp.
- Decided: Oct 15, 1998 after 76 days
- Product code: MOI (System, Test, Immunological, Antigen, Tumor)
- Device class: 2
- Regulation: 21 CFR 866.6010
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K981698 (1998). 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)
- K981698: Acs:180 BR (Automated Chemiluminescence System for the Quantitation of Cancer Antigen 27.29), Chiron Corp. (1998) Summary page 1.

## Most influential descendants
- K193489: ADVIA Centaur BR (2020), 0 descendants of its own

## Recalls of this device
- Jul 6, 2021 · Class II · Z-2426-2021: Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU calibration updated interval from 10 days to 3 days for all current and future kit lot numbers
- Jul 6, 2021 · Class II · Z-2424-2021: Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU calibration updated interval from 10 days to 3 days for all current and future kit lot numbers
- Jul 6, 2021 · Class II · Z-2425-2021: Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU calibration updated interval from 10 days to 3 days for all current and future kit lot numbers
- Mar 8, 2017 · Class II · Z-1747-2017: Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the ADVIA Centaur Systems
- Mar 8, 2017 · Class II · Z-1749-2017: Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the ADVIA Centaur Systems
- Mar 8, 2017 · Class II · Z-1748-2017: Potential for the ADVIA Centaur Syphilis assay to interfere with the BR (CA 27.29) a assay on the ADVIA Centaur Systems
- Nov 14, 2012 · Class II · Z-0512-2013: Operating range of the ADVIA Centaur systems is 18C to 30C (64.4F to 86.0F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur syst
- Nov 14, 2012 · Class II · Z-0507-2013: Operating range of the ADVIA Centaur systems is 18C to 30C (64.4F to 86.0F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur syst
- Sep 11, 2012 · Class II · Z-0162-2013: BR Assay for CA 27.29 Calibration Interval Change due quality control (QC) results outside of the expected ranges.

## Indications for use
The Chiron Diagnostics ACS:Centaur BR assay 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:Centaur” Automated Chemiluminescence System. The test is intended for use as an aid in monitoring patients previously treated for Stage Il or Stage il 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 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/K982680
Methodology: https://510kreport.com/methodology