# K132058: Vidas FT4

- Pathway: 510(k) (Traditional)
- Applicant: Biomerieux S.A.
- Decided: Jun 8, 2015 after 705 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.
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)
- K961489: Elecsys FT4 Assay, Boehringer Mannheim Corp. (1996) Summary page 4.

## Indications for use
VIDAS® FT4 is an automated quantitative enzyme immunoassay for use on the instruments of the VIDAS® family, for the determination of free thyroxine (FT4) in human serum or plasma (lithium heparin), using the ELFA technique (Enzyme Linked Fluorescent Assay). Measurement of Free Thyroxin is intended for use as an aid in the diagnosis and treatment monitoring of thyroid disorders.

Source page: https://510kreport.com/device/K132058
Methodology: https://510kreport.com/methodology