# K191350: ACTIVE® Free Testosterone RIA

- Pathway: 510(k) (Special)
- Applicant: Immunotech S.R.O.
- Decided: Dec 20, 2019 after 214 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: 1 generation back to K952281 (1995). 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)
- K952281: Active Free Testosterone Ria, Diagnostic Systems Laboratories, Inc. (1995) Summary page 4.

## Indications for use
Radioimmunoassay for the quantitative measurement of free testosterone in human serum. This assay is intended for in vitro diagnostic use. Free testosterone test is used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in female’s hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.

Source page: https://510kreport.com/device/K191350
Methodology: https://510kreport.com/methodology