# K040181: Access Dhea-S Reagent Assay

- Pathway: 510(k) (Abbreviated)
- Applicant: Beckman Coulter, Inc.
- Decided: Mar 24, 2004 after 57 days
- Product code: JKC (Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate))
- Device class: 1
- Regulation: 21 CFR 862.1245
- 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 K935806 (1994). 2 ancestors in all.
1 later device descends 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)
- K935806: Immulite Dhea-S04, Diagnostic Products Corp. (1994) Summary page 1.
- K003098: Access Ultrasensitive HGH Calibrators, Beckman Coulter, Inc. (2000) Summary page 1.

## Most influential descendants
- K111762: ST Aia-Pack Dhea-S Calibrator Set (2011), 0 descendants of its own

## Indications for use
The Access DHEA-S assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Dehydroepiandrosterone sulfate levels in human serum and plasma using the Access Immunoassay Systems. Measurement of dehydroepiandrosterone sulfate may be used in the differential diagnosis of Cushing's syndrome, as well as in the evaluation of adrenocortical diseases, such as congenital adrenal hyperplasia and adrenal tumors. In hirsute female patients, increased DHEA-S levels have been associated with virilizing adrenal tumors. Patients with polycystic ovary syndrome have often demonstrated elevated levels of DHEA-S, suggesting an adrenal androgen contribution to the defect in this disorder. The Access DHEA-S Calibrators are intended to calibrate the Access DHEA-S assay for the quantitative determination of Dehydroepiandrosterone sulfate levels in human serum and plasma using the Access Immunoassay Systems.

Source page: https://510kreport.com/device/K040181
Methodology: https://510kreport.com/methodology