# K080167: Acs 180 and Advia Centaur FT4 Immunoassays

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Aug 8, 2008 after 198 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: 1 generation back to K961510 (1996). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961510: Acs FRT4 Immunoassay, Ciba Corning Diagnostics Corp. (1996) Summary page 1.

## Most influential descendants
- K182423: Maglumi 2000 FT4 (2018), 0 descendants of its own
- K132249: Advia Centaur FT4, Advia Centaur T4 (2013), 0 descendants of its own

## Indications for use
The ADVIA Centaur FT4 Immunoassay is 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 diseases.

Source page: https://510kreport.com/device/K080167
Methodology: https://510kreport.com/methodology