# K220456: Elecsys FT4 IV

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Apr 7, 2023 after 414 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: 3 generations back to K900883 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131244: Elecsys FT4 II Assay, Elecsys FT4 II Calset, Roche Diagnostics (2014) Summary page 4.

## Indications for use
Assay 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 disease. The electrochemiluminescence immunoassay “ECLIA” is intended for use on the cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K220456
Methodology: https://510kreport.com/methodology