# K152227: Elecsys Cortisol II, Cortisol II CalSet

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Apr 27, 2016 after 264 days
- Product code: JFT (Fluorometric, Cortisol)
- 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: 3 generations back to K011323 (2001). 3 ancestors in all.
1 later device descends 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)
- K070788: Elecsys Cortisol Test System, Roche Diagnostics (2007) Summary page 5.

## Most influential descendants
- K202136: IDS Cortisol (2021), 0 descendants of its own

## Indications for use
Immunoassay for the in vitro quantitative determination of cortisol in human serum, and plasma. 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. Cortisol II CalSet is used for calibrating the quantitative Elecsys Cortisol II assay on the Elecsys and cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K152227
Methodology: https://510kreport.com/methodology