# K030730: Free Testosterone Enzymeimmunoassay (Eia) Kit

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostics Biochem Canada, Inc.
- Decided: Aug 18, 2003 after 161 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 K844423 (1985). 1 ancestor in all.
2 later devices descend 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)
- K844423: Coat-a-Count Free Testosterone Kit & Components, Diagnostic Products Corp. (1985) Summary page 1.

## Most influential descendants
- K181017: Free Testosterone AccuBind ELISA Test System (2018), 1 descendant of its own
- K240865: IDS-iSYS Free Testosterone (2024), 0 descendants of its own

## Indications for use
The dbc CAN-fTE-260 EiAsyTMFree Testosterone enzymeimmunoassay (EiA) kit provides the reagents necessary for the direct determination of Free Testosterone in human serum. This assay is intended for in vitro diagnostic use only. Measurement of Free Testosterone are used in the diagnosis in male sex hormones (androgens) and in females hrsutism (excessive hair) and virilisation (masculinization).

Source page: https://510kreport.com/device/K030730
Methodology: https://510kreport.com/methodology