# K014120: Testosterone by Enzymeimmunoassay (Eia)

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostics Biochem Canada, Inc.
- Decided: Feb 8, 2002 after 53 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 K971823 (1997). 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)
- K971823: Active Testosterone Eia (DSL-10-4000), Diagnostic Systems Laboratories, Inc. (1997) Summary page 1.

## Indications for use
The dbc CAN-TE-250 EiAsy™ Testosterone enzymeimmunoassay (EiA) kit provides the reagents necessary for the direct determination of Testosterone in human serum The use of this assay is intended for in vitro diagnostic use only. Measurement of Testosterone are used in the diagnosis and treatment of disorders involving the male sex hormone (androgens), including primary and secondary hypogonadism, delayed or precocious puberty impotence in male and in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries and adrenogenital syndromes.

Source page: https://510kreport.com/device/K014120
Methodology: https://510kreport.com/methodology