# K032525: Bayer Advia Centaur Automated Chemiluminescence Analyzer

- Pathway: 510(k) (Special)
- Applicant: Bayer Healthcare, LLC
- Decided: Sep 9, 2003 after 25 days
- Product code: NBC (Test, Natriuretic Peptide)
- Device class: 2
- Regulation: 21 CFR 862.1117
- 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 K902336 (1990). 2 ancestors in all.
18 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971418: Chiron Diagnostics Automated Chemiluminescence System (Asc) Centaur Analyzer, Chiron Diagnostics Corp. (1997) Summary page 1.

## Most influential descendants
- 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
- K093318: Accelerator Aps (2010), 3 descendants of its own

## Indications for use
The Buyer ADvLl Centaur is a n automated immunoassay analyzer designed to perform i n vitro diagnostic immunochemical assay analysis on clinical specimens. The system menu will include endocrine, anemia, allergy, reproductive, cardiovascular, oncology, adrenal, bone metabolism, therapeutic drug, and infectious disease assays, All assays are based on chemiluminescent technology.

Source page: https://510kreport.com/device/K032525
Methodology: https://510kreport.com/methodology