# K091867: Advia Centaur SHBG Readypack, Low and High Calibrators and Master Curve Material, Models 06520781, 04819274 and 06520773

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Jan 14, 2010 after 205 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
No predicates in its family tree.
3 later devices descend 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)
- None. The FDA summary names no predicate by number.

## 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
- 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
The AD VIA Centaur® SHB80 assay is an in vitro diagnostic immunoassay for the quantitative determination of sex hormone-binding globulin (SHBG) in human serum and plasma using the AD VIA Centaur systems. The AD VIA Centaur SHBG assay is intended for use asian aid in the diagnosis~of androgen disorders. The ADVIA Centaur SHBG Calibrators are formi vitro diagnostic use in calibrating the ADVIA Centaur sex hormone-binding globulin (SHBG) assays. The ADVIA Centaur SHBG Master Curve Material are for in vitro diagnostic use in the verification of calibration and reportable range in the AD VIA Centaur sex hormone-binding globulin (SH-BG) assay.

Source page: https://510kreport.com/device/K091867
Methodology: https://510kreport.com/methodology