# K141999: Advia Centaur TSH

- Pathway: 510(k) (Special)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Apr 22, 2015 after 273 days
- Product code: JLW (Radioimmunoassay, Thyroid-Stimulating Hormone)
- Device class: 2
- Regulation: 21 CFR 862.1690
- 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: 1 generation back to K910981 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910981: Ciba Corning Acs TSH Immunoassay, Ciba Corning Diagnostics Corp. (1991) Summary page 4.
- (no number) ADVIA Centaur XP system: named in the summary without a submission number

## Recalls of this device
- Feb 2, 2017 · Class II · Z-1537-2017: Multiple software issues, which may affect the operation and workflow of the system. Potential for an apparent delay to testing when these issues occur. The software issues affecting the analyzer may 
- May 26, 2016 · Class II · Z-2256-2016: Eight (8) issues were identified which may affect the results generated by the system software version.
- Apr 28, 2016 · Class II · Z-0072-2017: The ADVIA Centaur XPT default setting for the Daily Maintenance Task (Daily Cleaning Procedure) frequency may have the Daily Maintenance Task frequency set to, As needed instead of Daily. Not performi

## Indications for use
For in vitro diagnostic use in the quantitative determination of thyroid-stimulating hormone (TSH, thyrotropin) in serum using the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT systems. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

Source page: https://510kreport.com/device/K141999
Methodology: https://510kreport.com/methodology