# K102841: Pantex AM/PM Salivary Cortisol Enzyme Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Pantex, Div. Bio-Analysis, Inc.
- Decided: May 8, 2012 after 587 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 K011323 (2001). 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)
- K011323: High Sensitivity Cortisol Enzyme Immunoassay, Model 1-0101/1-0102, Salimetrics, LLC (2001)

## Most influential descendants
- K150528: Cortisol Saliva Luminescence Immunoassay (2015), 0 descendants of its own

## Indications for use
For the in-vitro diagnostic quantitative determination of free and protein bound salivary cortisol in human saliva as an aid in the assessment of Cushing Syndrome and Addison's Disease. Measurements of cortisol in saliva are used in the diagnosis and treatment of disorders of the adrenal gland.

Source page: https://510kreport.com/device/K102841
Methodology: https://510kreport.com/methodology