# K041133: Modification to Bayer Advia Centaur Automated Chemiluminescence Analyzer

- Pathway: 510(k) (Special)
- Applicant: Bayer Healthcare, LLC
- Decided: Jul 2, 2004 after 63 days
- Product code: CDD (Radioassay, Vitamin B12)
- Device class: 2
- Regulation: 21 CFR 862.1810
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K902336 (1990). 3 ancestors in all.
17 later devices descend from it; 5 cite 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)
- K032525: Bayer Advia Centaur Automated Chemiluminescence Analyzer, Bayer Healthcare, LLC (2003) Summary page 1.

## Most influential descendants
- 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
- K213486: GLP systems Track (2022), 1 descendant of its own

## Recalls of this device
- Jul 28, 2017 · Class II · Z-0720-2018: Siemens has identified an issue when scanning the 20 barcode for the Master Curve Card (MCC) with ADVIA Centaur systems T3 kit lots ending in 198 on the ADVIA Centaur XPT system.
- Mar 30, 2016 · Class III · Z-1615-2016: The firm identified an issue in sample processing when using EZee-Nest Insert Cups due to two inaccuracies that exist in the ADVIA Centaur CP Operators Guide.
- Oct 9, 2014 · Class II · Z-0859-2015: A slight crack of the tubing at the connecting fitting on the reservoir connector assembly may occur due to mechanical stress.
- Oct 9, 2014 · Class II · Z-0860-2015: A slight crack of the tubing at the connecting fitting on the reservoir connector assembly may occur due to mechanical stress.
- Aug 19, 2014 · Class II · Z-2715-2014: The firm has identified an issue with patient demographic information sent to the LIS from the ADVIA Centaur/ADVIA Centaur XP Immunoassay systems. Siemens has confirmed that under extremely rare circu
- Aug 19, 2014 · Class II · Z-2716-2014: The firm has identified an issue with patient demographic information sent to the LIS from the ADVIA Centaur/ADVIA Centaur XP Immunoassay systems. Siemens has confirmed that under extremely rare circu
- Aug 13, 2014 · Class II · Z-2662-2014: The firm is conducting a field correction for the ADVIA Centaur and ADVIA Centaur XP Immunoassay systems, regarding manually loaded sample racks that are improperly loaded or pushed too far on the sam
- Aug 13, 2014 · Class II · Z-2663-2014: The firm is conducting a field correction for the ADVIA Centaur and ADVIA Centaur XP Immunoassay systems, regarding manually loaded sample racks that are improperly loaded or pushed too far on the sam

## Indications for use
The BayerADVIA Centauris an automated immunoassay analyzer designed to perform in 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/K041133
Methodology: https://510kreport.com/methodology