# K211685: Elecsys Testosterone II

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: May 6, 2022 after 338 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 K964889 (1997). 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)
- K093421: Elecsys Testosterone II Immunoassay, Roche Diagnostics Corp. (2010) Summary page 4.

## Most influential descendants
- K252728: IDS-iSYS Total Testosterone (2026), 0 descendants of its own

## Indications for use
Immunoassay for the in vitro quantitative determination of testosterone in human serum and plasma. The electrochemiluminescence immunoassay “ECLIA” is intended for use on the cobas e 601 immunoassay analyzer. Measurements of testosterone are 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 females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.

Source page: https://510kreport.com/device/K211685
Methodology: https://510kreport.com/methodology