# K984520: Nichols Advantage Chemiluminescence Cortisol Immunoassay, Model 62-7005

- Pathway: 510(k) (Traditional)
- Applicant: Nichols Institute Diagnostics
- Decided: Feb 5, 1999 after 46 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 K962208 (1997). 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)
- K962208: Nichols Advantage Chemiluminescence Cortisol Kit, Nichols Institute Diagnostics (1997) Summary page 1.

## Indications for use
The Nichols Advantage® Chemiluminescence Cortisol Inmunoassay is intended for use with the Nichols Advantage® Specialty System for the quantitative determination of cortisol concentration in human serum, EDTA 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/K984520
Methodology: https://510kreport.com/methodology