# K030329: Fastpack Free T4 Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Qualigen, Inc.
- Decided: Jul 3, 2003 after 153 days
- Product code: CEC (Radioimmunoassay, Free Thyroxine)
- Device class: 2
- Regulation: 21 CFR 862.1695
- 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 K902834 (1990). 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)
- K902834: Abbott Imx Free T4, Abbott Laboratories (1990) Summary page 1.

## Recalls of this device
- Nov 8, 2013 · Class II · Z-0549-2014: Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.

## Indications for use
The FastPack" Free T4 Immunoassay is a paramagnetic particle, chemiluminescence immunoassay for the in vitro quantitative determination of free thyroxine (FT4) in human serum. The Fastpack@Free Td Immunoassay is designed for use with the Fastpack@Analyzer System. It is intended strictly for in vitro diagnostic use as an aid in the diagnosis and management of yroid dysfunction. The FastPack@ TestoEree Tq Calibrator is intended to calibrate the FastF'ack@Analyzer system when used for the quantitative determination of Total Testosterone or Free T4 in hwnan serum

Source page: https://510kreport.com/device/K030329
Methodology: https://510kreport.com/methodology