# K954733: Access Cortisol Assay (Modification)

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories, Inc.
- Decided: Dec 5, 1995 after 64 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
No predicates in its family tree.
3 later devices descend 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K050202: Cortisol and Cortisol Calibrators on the Access Immunoassay Systems (2005), 2 descendants of its own
- 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
- Feb 17, 2010 · Not classified · Z-2621-2010: The recall was initiated by Beckman Coulter after the firm confirmed customer reports that the affected lot of Access Cortisol reagent (REF 33600) identified above may produce suppressed patient resul

Source page: https://510kreport.com/device/K954733
Methodology: https://510kreport.com/methodology