# K062204: Architect Cortisol Assay

- Pathway: 510(k) (Traditional)
- Applicant: Seradyn, Inc.
- Decided: Sep 22, 2006 after 52 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 K033731 (2004). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033731: Axsym Cortisol Assay, Fujirebio Diagnostics,Inc. (2004) Summary page 1.

## Most influential descendants
- K242505: Elecsys Cortisol III (2025), 0 descendants of its own

## Indications for use
ARCHITECT Cortisol is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cortisol in human serum, plasma or urine on the ARCHITECT i System. The ARCHITECT Cortisol assay is intended for use as an aid in the diagnosis and treatment of adrenal disorders. The ARCHITECT Cortisol Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of cortisol in human serum, plasma or urine.

Source page: https://510kreport.com/device/K062204
Methodology: https://510kreport.com/methodology