# K101390: Fastpack TSH Immunoassay

- Pathway: 510(k) (Special)
- Applicant: Qualigen, Inc.
- Decided: Aug 13, 2010 after 88 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The FastPack® TSH Inmmuoassay .is a paramagnetic particle immunoassay for the in-vitro quantitative determnination of TSH in human serum or plasma. The measurements of thyroid stimulating hormone (TSH) produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. FastPack® TSH Immunoassay is designed for use with the FastPack® System.

Source page: https://510kreport.com/device/K101390
Methodology: https://510kreport.com/methodology