# K971418: Chiron Diagnostics Automated Chemiluminescence System (Asc) Centaur Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Chiron Diagnostics Corp.
- Decided: Jul 17, 1997 after 92 days
- Product code: MOI (System, Test, Immunological, Antigen, Tumor)
- Device class: 2
- Regulation: 21 CFR 866.6010
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K902336 (1990). 1 ancestor in all.
21 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902336: Ciba Corning Acs:180 Automated Chemiluminescence, Ciba Corning Diagnostics Corp. (1990) Summary page 1.

## Most influential descendants
- K032525: Bayer Advia Centaur Automated Chemiluminescence Analyzer (2003), 18 descendants of its own
- K041133: Modification to Bayer Advia Centaur Automated Chemiluminescence Analyzer (2004), 17 descendants of its own
- K151792: Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System (2015), 4 descendants of its own
- K082638: Advia Centaur System with Streamlab Analytical Workcell (2009), 4 descendants of its own
- K071224: Dimension Vista Vitamin B12 and Folate Flex Reagent Cartridges and Loci 4 Calibrator (2007), 4 descendants of its own

## Recalls of this device
- Feb 18, 2014 · Class II · Z-1553-2014: Instrument Cover Gas Spring failures. Over time, the gas spring may lose its effectiveness and fail to support the cover in its full or partially open position. This may lead to the cover falling.
- Jan 12, 2008 · Not classified · Z-1119-2008: Incorrect results: False reactive specimens on the ADVIA Centaur HAV IgM assay.
- Nov 9, 2006 · Not classified · Z-0645-2007: Firm received complaints for signal 2 & 4 errors, and shifts in Relative Light Units (RLU). Investigations showed that the On-Board Stability (OBS) of the acid & base reagents may be compromised after
- Aug 4, 2006 · Not classified · Z-1516-06: Sample/Patient mis-identification (software defect)-the system can associate a test result and sample identification (SID) with an incorrect patient name when the Patient Demographics feature is used 

## Indications for use
The intended use of the ACS:Centaur system is an automated immunoassay analyzer designed to perform in vitro diagnostic immunochemical assays analysis on clinical specimens using the ACS iimmunoassays. The system menu will include endocrine, anemia, reproductive, cardiac, therapeutic drug, and infectious disease assays. All assays are based on chemiluminescent technology.proteins and is an indirect indicator of thyroid status.4

Source page: https://510kreport.com/device/K971418
Methodology: https://510kreport.com/methodology