# NHG: Enzyme Immunoassay, Cortisol, Salivary

- Device class: 2; regulation: 21 CFR 862.1205; FDA's rule: 510(k) required
- FDA decisions: 7
- Recalls: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2001: 1
- 2003: 1
- 2004: 1
- 2005: 1
- 2007: 1
- 2012: 1
- 2015: 1

## Most-cited predicates
- K011323: High Sensitivity Cortisol Enzyme Immunoassay, Model 1-0101/1-0102 (2001), cited by 2
- K043175: Elecsys Cortisol Test System, Addition of Saliva Sample Type (2004), cited by 1
- K102841: Pantex AM/PM Salivary Cortisol Enzyme Immunoassay (2012), cited by 1
- K070788: Elecsys Cortisol Test System (2007), cited by 1

Source page: https://510kreport.com/product-code/NHG
Data by year (CSV): https://510kreport.com/product-code/NHG.csv