# K043175: Elecsys Cortisol Test System, Addition of Saliva Sample Type

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Nov 24, 2004 after 8 days
- Product code: NHG (Enzyme Immunoassay, Cortisol, Salivary)
- Device class: 2
- Regulation: 21 CFR 862.1205
- Recalls of this device: 1 (0 Class I)
- 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.
3 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)
- K011323: High Sensitivity Cortisol Enzyme Immunoassay, Model 1-0101/1-0102, Salimetrics, LLC (2001) Summary page 2.

## Most influential descendants
- K070788: Elecsys Cortisol Test System (2007), 2 descendants of its own
- K152227: Elecsys Cortisol II, Cortisol II CalSet (2016), 1 descendant of its own
- K202136: IDS Cortisol (2021), 0 descendants of its own

## Recalls of this device
- May 15, 2007 · Not classified · Z-0977-2007: The test is not as sensitive, or as precise between runs, as claimed in the labeling. Low concentrations are observed only in saliva samples.

## Indications for use
The Elecsys Cortisol is an immunoassay for the in-vitro quantitative determination of cortisol in 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 the Roche Elecsys 101012010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers.

Source page: https://510kreport.com/device/K043175
Methodology: https://510kreport.com/methodology