# K021218: Elecsys Cortisol Test System

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Sep 9, 2002 after 145 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: 1 generation back to K962559 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962559: Acs Cortisol Immunoassay, Ciba Corning Diagnostics Corp. (1996) Summary page 2.

## Indications for use
Immunological in vitro assay for the quantitative determination of cortisol in human serum, plasma and 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 the Roche Elecsys® 1010 / 2010 and Modular Analytics E 170 (Elecsys module) Immunoassay Analyzers.

Source page: https://510kreport.com/device/K021218
Methodology: https://510kreport.com/methodology