# K242505: Elecsys Cortisol III

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Jul 17, 2025 after 329 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: 2 generations back to K033731 (2004). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062204: Architect Cortisol Assay, Seradyn, Inc. (2006) Summary page 6.

## Indications for use
Immunoassay for the in vitro quantitative determination of cortisol in human urine. 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 cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K242505
Methodology: https://510kreport.com/methodology