# K132249: Advia Centaur FT4, Advia Centaur T4

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Sep 13, 2013 after 56 days
- Product code: CEC (Radioimmunoassay, Free Thyroxine)
- Device class: 2
- Regulation: 21 CFR 862.1695
- 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 K961510 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080167: Acs 180 and Advia Centaur FT4 Immunoassays, Siemens Healthcare Diagnostics (2008) Summary page 1.

## Cited in the summary but kept off the family tree
- K090532: T.E.a.R. TECH3, Vision Quest Industries, Inc. (2009). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
For in vitro diagnostic use in the quantitative determination of free thyroxine (FT4) in serum or plasma (heparinized or EDTA), using the ADVIA Centaur and ADVIA Centaur XP systems. Measurements of free thyroxine are used in the diagnosis and treatment of thyroid disease. For in vitro diagnostic use in the quantitative determination of thyroxine (T4) in serum using the ADVIA Centaur and ADVIA Centaur XP systems. Measurements of thyroxine are used in the diagnosis and treatment of thyroid disease.

Source page: https://510kreport.com/device/K132249
Methodology: https://510kreport.com/methodology