# K130469: Liaison TSH, Liaison Control Thyroid 1, Liaison Control Thyroid 2, Liaison Control Thyroid 3

- Pathway: 510(k) (Traditional)
- Applicant: DiaSorin, Inc.
- Decided: Apr 5, 2013 after 39 days
- Product code: JLW (Radioimmunoassay, Thyroid-Stimulating Hormone)
- Device class: 2
- Regulation: 21 CFR 862.1690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K931172 (1993). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961491: Elecsys TSH Assay, Boehringer Mannheim Corp. (1996) Summary page 1.
- K090541: Elecsys Precicontrol Universal, Roche Diagnostics (2009) Summary page 1.

## Indications for use
The DiaSorin LIAISON® TSH assay is an in vitro chemiluminescent immunoassay intended for the quantitative determination of thyroid stimulating hormone (TSH), also known as thyrotropin and thyrotropic hormone, in human serum. The test has to be performed on the LIAISON®XL Analyzer. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. 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® TSH assay.

Source page: https://510kreport.com/device/K130469
Methodology: https://510kreport.com/methodology