# K022533: Fastpack Testosterone Calibrator

- Pathway: 510(k) (Abbreviated)
- Applicant: Qualigen, Inc.
- Decided: Sep 30, 2002 after 61 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K844423 (1985). 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)
- K844423: Coat-a-Count Free Testosterone Kit & Components, Diagnostic Products Corp. (1985) Summary page 1.

## Indications for use
The Fastpack@Testosterone Calibrator is intended to calibrate the Fastpack@Analyzer system when used for the quantitativedetermination of Testosterone in human serum.

Source page: https://510kreport.com/device/K022533
Methodology: https://510kreport.com/methodology