# 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

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Jun 29, 2016 after 348 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: 5 generations back to K924862 (1992). 15 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 18 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 6.
- K140505: Advia Centaur Vitamin B12 Master Curve Material, Total HCG Master Curve Material, and Testosterone Master Curve Material, Siemens Healthcare Diagnostics, Inc. (2014) Summary page 6.
- K091867: Advia Centaur SHBG Readypack, Low and High Calibrators and Master Curve Material, Models 06520781, 04819274 and 06520773, Siemens Healthcare Diagnostics (2010) Summary page 7.

## Most influential descendants
- K191533: ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG (2019), 0 descendants of its own
- K190121: Ids SHBG (2019), 0 descendants of its own

## Indications for use
ADVIA Centaur® Testosterone II (TSTII) The ADVIA Centaur Testosterone II (TSTII) assay is for in vitro diagnostic use in the quantitative determination of total testosterone (bound and unbound) in human serum and plasma using the ADVIA Centaur XP system. 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. ADVIA Centaur® Testosterone II (TSTII) Master Curve Material The ADVIA Centaur Testosterone II (TSTII) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur Testosterone II (TSTII) assay. ADVIA Centaur® SHBG The ADVIA Centaur SHBG assay is an in vitro diagnostic immunoassay for the quantitative determination of sex hormone-binding globulin (SHBG) in human serum and plasma using the ADVIA Centaur XP system. The ADVIA Centaur SHBG assay is intended for use as an aid in the diagnosis of androgen disorders. ADVIA Centaur® SHBG Calibrator For in vitro diagnostic use in calibrating the ADVIA Centaur SHBG assay on the ADVIA Centaur systems. ADVIA Centaur® SHBG Master Curve Material The ADVIA Centaur SHBG Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur SHBG assay.

Source page: https://510kreport.com/device/K151986
Methodology: https://510kreport.com/methodology