# K042689: Nichols Advantage Cortisol

- Pathway: 510(k) (Traditional)
- Applicant: Nichols Institute Diagnostics
- Decided: Dec 9, 2004 after 71 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: 1 generation back to K810891 (1981). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K810891: Coat-a-Count Cortisol Ria Kit, Diagnostic Products Corp. (1981) Summary page 1.

## Indications for use
The Nichols Advantage® Cortisol assay is intended for use with the Nichols Advantage® Specialty System for the quantitative determination of cortisol concentrations in human serum, EDTA plasma and urine. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland. The Nichols Advantage Cortisol Assay Calibrators are intended for adjustment of the stored curve for the Nichols Advantage Cortisol assay.

Source page: https://510kreport.com/device/K042689
Methodology: https://510kreport.com/methodology