# K133303: PANTEX SALIVARY DIRECT TESTOSTERONE EIA KIT, Pantex Sample Collection Device

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Analysis, Inc.
- Decided: Nov 19, 2014 after 390 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- 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 K033786 (2004). 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)
- K033786: Luminescent Immunoassay Kit for the Detection of Testosterone in Serum and Saliva, Ibl GmbH (2004) Summary page 4.

## Indications for use
The Pantex Salivary Direct Testosterone EIA Kit is an Enzyme Immunoassay (EIA) for the quantitative measurement of testosterone in human saliva collected with the Pantex Sample Collection Device. The 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 females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries and andrenogential syndromes.

Source page: https://510kreport.com/device/K133303
Methodology: https://510kreport.com/methodology