# K082638: Advia Centaur System with Streamlab Analytical Workcell

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Feb 26, 2009 after 169 days
- Product code: KLI (Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine)
- Device class: 2
- Regulation: 21 CFR 862.1700
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K902336 (1990). 6 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041133: Modification to Bayer Advia Centaur Automated Chemiluminescence Analyzer, Bayer Healthcare, LLC (2004) Summary page 1.
- K043546: Dimension RXL Max with Streamlab Analytical Workcell and Sample Transfer Module, Dade Behring, Inc. (2005) Summary page 1.
- K905532: Ciba Corning Acs T4 Immunoassay, Ciba Corning Diagnostics Corp. (1991) Summary page 1.

## Most influential descendants
- K093318: Accelerator Aps (2010), 3 descendants of its own
- K213486: GLP systems Track (2022), 1 descendant of its own
- K230937: Alinity i Total ß-hCG Reagent Kit, GLP systems Track (2023), 0 descendants of its own
- K121012: Flexlab 3.6, Accelerator A3600 (2012), 0 descendants of its own

## Recalls of this device
- Aug 14, 2018 · Class II · Z-0215-2019: The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.
- Aug 14, 2018 · Class II · Z-0216-2019: The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.
- Aug 14, 2018 · Class II · Z-0217-2019: The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.

## Indications for use
The ADVIA Centaur with StreamLAB® Analytical Workcell is an automated immunoassay analyzer designed to perform in vitro diagnostic immunochemical assay analysis on clinical specimens. The system menu will include assays based on chemiluminescent technology, such as Thyroxine, along with other various chemiluminescent assays that may be adaptable to the analyzer depending on the reagent used to induce the chemiluminescent reaction. The ADVIA CentaurT4 assay is for in vitro diagnostic use in the quantitative determination of thyroxine (T4) in serum on the ADVIA Centaur and ADVIA Centaur XP systems. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.

Source page: https://510kreport.com/device/K082638
Methodology: https://510kreport.com/methodology