# K041014: TSH-CTK-3 Irma

- Pathway: 510(k) (Traditional)
- Applicant: DiaSorin, Inc.
- Decided: Jul 14, 2004 after 85 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: 1 generation back to K920856 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920856: Ventrex Coated Tube High Sensit. TSH Radioimmunoas, Hycor Biomedical, Inc. (1992) Summary page 2.

## Indications for use
The DiaSorin TSH-CTK-3 is an imlunoradiometric assay for the quantitative determination of thyrotropin (TSH) in human serum. Measurements of TSH levels are used as an aid in the diagnosis of thyroid or pituitary disorders.

Source page: https://510kreport.com/device/K041014
Methodology: https://510kreport.com/methodology