# K120009: Testosterone Test System; Calibrator; and Quality Control Material (Assayed and Unassayed)

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Sep 11, 2012 after 252 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.
2 later devices descend from it; 2 cite it directly.
0 of 5 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 2.

## Most influential descendants
- K153577: FREND Testosterone Test System (2016), 0 descendants of its own
- K152155: ARCHITECT 2nd Generation Testosterone (2015), 0 descendants of its own

## Indications for use
The ARCHITECT 2nd Generation Testosterone assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of testosterone in human serum and plasma. 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. The ARCHITECT 2nd Generation Testosterone Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of testosterone in human serum and plasma. The ARCHITECT 2nd Generation Testosterone Controls are for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of testosterone in human serum and plasma.

Source page: https://510kreport.com/device/K120009
Methodology: https://510kreport.com/methodology