# K101388: Fastpack Testo Immunoassay

- Pathway: 510(k) (Special)
- Applicant: Qualigen, Inc.
- Decided: Feb 18, 2011 after 277 days
- Product code: CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone)
- Device class: 1
- Regulation: 21 CFR 862.1680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K964889 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021972: Fastpack Total Testosterone Immunoassay, Qualigen, Inc. (2002) Summary page 3.

## Indications for use
The FastPack® Testo, Immunoassay is a paramagnetic particle immunoassay for the in-vitro quantitative determination of total testosterone in human serum. or plasma. The FastPack® Testo Inmmnoassay is designed for use with the FastPack® 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/K101388
Methodology: https://510kreport.com/methodology