# K021972: Fastpack Total Testosterone Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Qualigen, Inc.
- Decided: Aug 21, 2002 after 65 days
- Product code: CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone)
- Device class: 1
- Regulation: 21 CFR 862.1680
- 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 K964889 (1997). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964889: Elecsys Testosterone Assay, Boehringer Mannheim Corp. (1997) Summary page 1.

## Most influential descendants
- K101388: Fastpack Testo Immunoassay (2011), 0 descendants of its own

## Recalls of this device
- Nov 8, 2013 · Class II · Z-0548-2014: Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.

## Indications for use
The FastPack® Total Testosterone Immunoassay is a paramagnetic particle, chemiluminescence immunoassay for the in vitro quantitative determination of testosterone in human serum. The FastPack® Total Testosterone 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 conditions involving excess or deficiency of this androgen

Source page: https://510kreport.com/device/K021972
Methodology: https://510kreport.com/methodology