# K131244: Elecsys FT4 II Assay, Elecsys FT4 II Calset

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Jan 27, 2014 after 271 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 K900883 (1990). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961489: Elecsys FT4 Assay, Boehringer Mannheim Corp. (1996) Summary page 1.

## Most influential descendants
- K220456: Elecsys FT4 IV (2023), 0 descendants of its own
- K181233: Elecsys FT4 III (2018), 0 descendants of its own

## Indications for use
The Elecsys FT4 II Assay is for the in vitro quantitative determination of free Thyroxine in human serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases. The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers. Elecsys FT4 II CalSet is used for calibrating the quantitative Elecsys FT4 II assay on the Elecsys and cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K131244
Methodology: https://510kreport.com/methodology