# K181017: Free Testosterone AccuBind ELISA Test System

- Pathway: 510(k) (Traditional)
- Applicant: Monobind, Inc.
- Decided: Jul 20, 2018 after 101 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: 2 generations back to K844423 (1985). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030730: Free Testosterone Enzymeimmunoassay (Eia) Kit, Diagnostics Biochem Canada, Inc. (2003) Summary page 4.

## Most influential descendants
- K240865: IDS-iSYS Free Testosterone (2024), 0 descendants of its own

## Indications for use
The Free Testosterone AccuBind® ELISA Test System is an Enzyme Immunoassay (EIA) for the quantitative measurement of free testosterone in human serum. 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 males and in females; hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries and adrogenital syndromes.

Source page: https://510kreport.com/device/K181017
Methodology: https://510kreport.com/methodology