# K011323: High Sensitivity Cortisol Enzyme Immunoassay, Model 1-0101/1-0102

- Pathway: 510(k) (Traditional)
- Applicant: Salimetrics, LLC
- Decided: Dec 17, 2001 after 230 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
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K043175: Elecsys Cortisol Test System, Addition of Saliva Sample Type (2004), 3 descendants of its own
- K070788: Elecsys Cortisol Test System (2007), 2 descendants of its own
- K152227: Elecsys Cortisol II, Cortisol II CalSet (2016), 1 descendant of its own
- K102841: Pantex AM/PM Salivary Cortisol Enzyme Immunoassay (2012), 1 descendant of its own
- K202136: IDS Cortisol (2021), 0 descendants of its own

Source page: https://510kreport.com/device/K011323
Methodology: https://510kreport.com/methodology