# K060480: Vitros Immunodiagnostic Products Cortisol Reagent Pack and Calibrators and Metabolism Controls

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics
- Decided: Jul 3, 2006 after 130 days
- Product code: CGR (Radioimmunoassay, Cortisol)
- Device class: 2
- Regulation: 21 CFR 862.1205
- 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 K854419 (1985). 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)
- K983990: Vitros Immunodiagnostic Products Cortisol Assay, Ortho-Clinical Diagnostics, Inc. (1998) Summary page 2.

## Indications for use
The measurement of cortisol in human serum, plasma (heparin or EDTA) or urine aids in the assessment of adrenal status.

Source page: https://510kreport.com/device/K060480
Methodology: https://510kreport.com/methodology