# K962559: Acs Cortisol Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Ciba Corning Diagnostics Corp.
- Decided: Nov 5, 1996 after 127 days
- Product code: JFT (Fluorometric, Cortisol)
- Device class: 2
- Regulation: 21 CFR 862.1205
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 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) Tdx® Cortisol Fluorescence Polarization Immunoassay: named in the summary without a submission number
- (no number) COAT-A-COUNT Cortisol Radioimmunoassay: named in the summary without a submission number

## Most influential descendants
- K142723: ADVIA Centaur Cortisol (COR) Assy (2015), 1 descendant of its own
- K192788: ADVIA Centaur Cortisol (COR) (2019), 0 descendants of its own
- K021218: Elecsys Cortisol Test System (2002), 0 descendants of its own

## Recalls of this device
- Mar 16, 2023 · Class II · Z-1505-2023: There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low.
- Mar 6, 2012 · Not classified · Z-1390-2012: Cortisol Assay reagent kit lots do not meet onboard stability and calibration interval claims

## Indications for use
For the quantitative determination of cortisol in serum using the Ciba Corning Automated Chemiluminescence Systems.

Source page: https://510kreport.com/device/K962559
Methodology: https://510kreport.com/methodology