# K983990: Vitros Immunodiagnostic Products Cortisol Assay

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Dec 29, 1998 after 50 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 K854419 (1985). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K854419: TDX Cortisol, Abbott Laboratories (1985) Summary page 2.

## Most influential descendants
- K060480: Vitros Immunodiagnostic Products Cortisol Reagent Pack and Calibrators and Metabolism Controls (2006), 0 descendants of its own

## Indications for use
For in vitro .quantitative measurement of cortisol in human serum, plasma (EDTA or heparin) or urine. For in vitro use in monitoring the performance of the VITROS Immunodiagnostic System when used for the measurement of cortisol in human serum, plasma (EDTA or heparin) or urine.

Source page: https://510kreport.com/device/K983990
Methodology: https://510kreport.com/methodology