# K102814: Elecysys SHBG

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Jan 20, 2011 after 114 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 K941797 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031717: Elecsys SHBG Immunoassay, Roche Diagnostics Corp. (2003) Summary page 2.

## Indications for use
Immunoassay for the in vitro quantitative determination of 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. The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K102814
Methodology: https://510kreport.com/methodology