# K083867: Access Sex Hormone Binding Globulin Reagent, Access Sex Hormone Binding Globulin Calibrators and Access Sex Hormone Bind

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Aug 27, 2009 after 241 days
- Product code: CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone)
- Device class: 1
- Regulation: 21 CFR 862.1680
- Recalls of this device: 1 (0 Class I)
- 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.
2 later devices descend from it; 2 cite 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)
- K941797: Immulite SHBG, Diagnostic Products Corp. (1994) Summary page 2.

## Most influential descendants
- K233480: Access SHBG (2024), 0 descendants of its own
- K182521: FastPack IP Sex Hormone Binding Globulin Immunoassay (2019), 0 descendants of its own

## Recalls of this device
- Jul 26, 2010 · Not classified · Z-0431-2011: The recall was initiated because the Instruction for Use (IFU) for Access SHBG does not specify the units of measure to be used when calculating the Free Androgen Index (FAI %). Access SHBG (nmol/L) v

## 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 Sex Hormone Binding Globulin assay is indicated for use in the assessment of androgen disorders. The Access SHBG Calibrators are intended to calibrate the Access SHBG assay for the quantitative determination of Sex Hormone Binding Globulin levels in human serum and plasma using the Access Immunoassay Systems. The Access SHBG QC is intended for monitoring system performance of the Access SHBG assay.

Source page: https://510kreport.com/device/K083867
Methodology: https://510kreport.com/methodology