# K031348: High Sensitivity Cortisol Enzyme Immunoassay

- Pathway: 510(k) (Special)
- Applicant: Salimetrics, LLC
- Decided: Jun 10, 2003 after 60 days
- Product code: NHG (Enzyme Immunoassay, Cortisol, Salivary)
- 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 K850141 (1985). 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)
- K850141: Active Cortisol DSL 2000-SP, Diagnostic Systems Laboratories, Inc. (1985) Summary page 1.

## Indications for use
Salimetrics HS-Cortisol kit is a competitive immunoassay specifically designed for the quantitative in vitro diagnostic measurement of salivary cortisol. This kit may be used to measure adrenal cortical function and as a screen for Cushing’s and Addison’s disease. Saliva cortisol accurately reflects the amount of serum cortisol in the circulation. This kit is not intended for use with serum or plasma samples.

Source page: https://510kreport.com/device/K031348
Methodology: https://510kreport.com/methodology