# K070788: Elecsys Cortisol Test System

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Oct 5, 2007 after 197 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: 2 generations back to K011323 (2001). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043175: Elecsys Cortisol Test System, Addition of Saliva Sample Type, Roche Diagnostics Corp. (2004) Summary page 2.

## Most influential descendants
- K152227: Elecsys Cortisol II, Cortisol II CalSet (2016), 1 descendant of its own
- K202136: IDS Cortisol (2021), 0 descendants of its own

## Indications for use
Eleesys Cortisol Immunoassay Immunoassay for the in vitro quantitative determination of cortisol in human serum, plasma, urine, and saliva. The determination of cortisol is used for the recognition and treatment of functional disorders of the adrenal gland. The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers. Eleesys Cortisol CalSet Elecsys Cortisol CalSet is used for calibrating the quantitative Elecsys Cortisol assay on the Elecsys immunoassay analyzers.

Source page: https://510kreport.com/device/K070788
Methodology: https://510kreport.com/methodology