# K033786: Luminescent Immunoassay Kit for the Detection of Testosterone in Serum and Saliva

- Pathway: 510(k) (Traditional)
- Applicant: Ibl GmbH
- Decided: Feb 27, 2004 after 85 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K133303: PANTEX SALIVARY DIRECT TESTOSTERONE EIA KIT, Pantex Sample Collection Device (2014), 0 descendants of its own

## Indications for use
The IBL Testosterone Luminescence Immunoassay is intended for the in vitro quantitative measurement of testosterone (a male sex hormone) in saliva and serum. Measurement of testosterone is used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.

Source page: https://510kreport.com/device/K033786
Methodology: https://510kreport.com/methodology