# K052301: Fastpack TSH Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Qualigen, Inc.
- Decided: Jan 4, 2006 after 135 days
- Product code: JLW (Radioimmunoassay, Thyroid-Stimulating Hormone)
- Device class: 2
- Regulation: 21 CFR 862.1690
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K942566 (1994). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942566: Imx Ultrasensistive HTSH II, Abbott Laboratories (1994) Summary page 1.

## Most influential descendants
- K123725: Fastpack Control Kit (2013), 0 descendants of its own
- K110761: Mict TSH (2012), 0 descendants of its own

## Recalls of this device
- Aug 26, 2024 · Class II · Z-0022-2025: Thyroid Stimulating Hormone (TSH) calibrator card has an incorrect barcode linked to incorrect information, that may allow successful system calibration, but the TSH results obtained could be higher t

## Indications for use
The FastPack® TSH Immunoassay is a paramagnetic particle, chemiluminescence immunoassay for the in vitro quantitative determination of Thyroid-Stimulating Hormone in human plasma. The measurements of thyroid stimulating hormone (TSH) produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. The FastPack® TSH is designed for use with the FastPack® System. The FastPack® TSH Calibrator is intended to calibrate the FastPack® System when used for the quantitative determination of TSH in human plasma. The FastPack ®Controls are assayed quality control materials for the verification of the accuracy and precision of the FastPack® System when used for the quantitative determination of PSA in human serum and plasma, and TSH in human plasma.

Source page: https://510kreport.com/device/K052301
Methodology: https://510kreport.com/methodology