# K142723: ADVIA Centaur Cortisol (COR) Assy

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Mar 31, 2015 after 189 days
- Product code: JFT (Fluorometric, Cortisol)
- Device class: 2
- Regulation: 21 CFR 862.1205
- Recalls of this device: 1 (0 Class I)
- 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.
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)
- K962559: Acs Cortisol Immunoassay, Ciba Corning Diagnostics Corp. (1996) Summary page 4.

## Most influential descendants
- K192788: ADVIA Centaur Cortisol (COR) (2019), 0 descendants of its own

## Recalls of this device
- Mar 16, 2023 · Class II · Z-1504-2023: There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low.

## Indications for use
The ADVIA Centaur® Cortisol (COR) Assay is for in vitro diagnostic use in the quantitative determination of cortisol in serum or 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/K142723
Methodology: https://510kreport.com/methodology