# K033731: Axsym Cortisol Assay

- Pathway: 510(k) (Traditional)
- Applicant: Fujirebio Diagnostics,Inc.
- Decided: Feb 20, 2004 after 84 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
No predicates in its family tree.
2 later devices descend 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)
- None. The FDA summary names its predicate without a number.
- (no number) Beckman Access® Cortisol assay: named in the summary without a submission number

## Most influential descendants
- K062204: Architect Cortisol Assay (2006), 1 descendant of its own
- K242505: Elecsys Cortisol III (2025), 0 descendants of its own

## Indications for use
The AxSYM® Cortisol assay is a Fluorescence Polarization Immunoassay (FPIA) for the quantitative measurement of Cortisol in human serum, plasma or urine on the AxSYM® System to aid in the diagnosis and treatment of adrenal disorders.

Source page: https://510kreport.com/device/K033731
Methodology: https://510kreport.com/methodology