# K050202: Cortisol and Cortisol Calibrators on the Access Immunoassay Systems

- Pathway: 510(k) (Special)
- Applicant: Beckman Coulter, Inc.
- Decided: Feb 9, 2005 after 12 days
- Product code: CGR (Radioimmunoassay, Cortisol)
- Device class: 2
- Regulation: 21 CFR 862.1205
- 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 K954733 (1995). 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)
- K954733: Access Cortisol Assay (Modification), Bio-Rad Laboratories, Inc. (1995) Summary page 1.

## Most influential descendants
- K242190: Access Cortisol; DxC 500i Clinical Analyzer (2025), 0 descendants of its own
- K223038: Access Cortisol (2023), 0 descendants of its own

## Recalls of this device
- Sep 18, 2018 · Class II · Z-2763-2019: Cross contamination may have occurred between wells for the reagent pack. As a result of this defect, patient results may be negatively impacted (falsely decreased) by up to 16%).

## Indications for use
The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Access Immunoassay Systems. A cortisol (hydrocortisone and hydroxycorticosterone) test system is a device intended to measure the cortisol hormones secreted by the adrenal gland in serum, plasma and urine. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.

Source page: https://510kreport.com/device/K050202
Methodology: https://510kreport.com/methodology