# K192788: ADVIA Centaur Cortisol (COR)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Nov 25, 2019 after 56 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 K962559 (1996). 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)
- K142723: ADVIA Centaur Cortisol (COR) Assy, Siemens Healthcare Diagnostics, Inc. (2015) Summary page 4.

## Indications for use
For in vitro diagnostic use in the quantitative determination of cortisol in serum, plasma (EDTA and lithium heparin), and urine using the ADVIA Centaur® XP system. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.

Source page: https://510kreport.com/device/K192788
Methodology: https://510kreport.com/methodology