# K031717: Elecsys SHBG Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Aug 5, 2003 after 63 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 K941797 (1994). 1 ancestor in all.
4 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941797: Immulite SHBG, Diagnostic Products Corp. (1994) Summary page 3.

## Most influential descendants
- K060818: Architect SHBG Reagent Kit, Architect SHBG Calibrator Kit, and Architect SHBG Control Kit with Models, 8K26-25, 8K26-01 (2007), 2 descendants of its own
- K152185: Architect SHBG (2016), 0 descendants of its own
- K143075: ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set (2015), 0 descendants of its own
- K102814: Elecysys SHBG (2011), 0 descendants of its own

## Indications for use
Immunoassay for the in vitro quantitative determination sex hormone binding globulin in human serum and plasma. The Elecsys SHBG Immunoassay is intended for use as an aid in the diagnosis of androgen disorders including hirsuitism, virilization, polycystic ovarian syndrome, adrenogenital syndrome, and hyperandrogenism; the correct interpretation of testosterone and estradiol concentrations; investigation of the androgen-estrogen balance in gonadal and sexual dysfunction; assessment of the peripheral effect of hormones which regulate SHBG concentrations. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys family of analyzers.

Source page: https://510kreport.com/device/K031717
Methodology: https://510kreport.com/methodology