# K121951: Liaison FT4 Liaison Control Thyroid 1 Liaison Control Thyroid 2 Liaison Control Thyroid 3

- Pathway: 510(k) (Traditional)
- Applicant: DiaSorin, Inc.
- Decided: Apr 4, 2013 after 275 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 1.

## Indications for use
The DiaSorin LIAISON® FT4 assay is an in vitro chemiluminescent immunoassay intended for the quantitative determination of free thyroxine (FT4) in human serum using the LIAISON® Analyzer. It is intended for use as an aid in the clinical assessment of thyroid status. The DiaSorin LIAISON® Control Thyroid 1, LIAISON® Control Thyroid 2 and LIAISON® Control Thyroid 3 are intended for use as assayed quality control samples to monitor the accuracy and precision of the DiaSorin LIAISON® FT4 assay

Source page: https://510kreport.com/device/K121951
Methodology: https://510kreport.com/methodology