# K240865: IDS-iSYS Free Testosterone

- Pathway: 510(k) (Traditional)
- Applicant: Immunodiagnostic Systems Limited
- Decided: Oct 23, 2024 after 209 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: 3 generations back to K844423 (1985). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181017: Free Testosterone AccuBind ELISA Test System, Monobind, Inc. (2018) Summary page 6.

## Indications for use
The IDS-iSYS Free Testosterone assay is an in vitro diagnostic device intended for the quantitative determination of free testosterone in human serum or plasma on the IDS system. Measurement of free testosterone is used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, impotence in male and in females; hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries and androgenital syndromes.

Source page: https://510kreport.com/device/K240865
Methodology: https://510kreport.com/methodology