# K093421: Elecsys Testosterone II Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Apr 23, 2010 after 171 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 K964889 (1997). 1 ancestor in all.
11 later devices descend from it; 5 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964889: Elecsys Testosterone Assay, Boehringer Mannheim Corp. (1997) Summary page 1.

## Most influential descendants
- K151986: ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material (2016), 2 descendants of its own
- K120009: Testosterone Test System; Calibrator; and Quality Control Material (Assayed and Unassayed) (2012), 2 descendants of its own
- K211685: Elecsys Testosterone II (2022), 1 descendant of its own
- K122793: Liaison Testosterone; Liaison Testosterone Control Set (2013), 1 descendant of its own
- 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 Elecsys and cobas e immunoassay analyzers. 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 androgenital syndromes.

Source page: https://510kreport.com/device/K093421
Methodology: https://510kreport.com/methodology