# K233480: Access SHBG

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Feb 8, 2024 after 105 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)
- K083867: Access Sex Hormone Binding Globulin Reagent, Access Sex Hormone Binding Globulin Calibrators and Access Sex Hormone Bind, Beckman Coulter, Inc. (2009) Summary page 4.

## Indications for use
The Access SHBG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Sex Hormone Binding Globulin levels in human serum and plasma using the Access Immunoassay Systems. The Access SHBG assay is indicated for use in the assessment of androgen disorders.

Source page: https://510kreport.com/device/K233480
Methodology: https://510kreport.com/methodology