# K854419: TDX Cortisol

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Nov 25, 1985 after 21 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
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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K983990: Vitros Immunodiagnostic Products Cortisol Assay (1998), 1 descendant of its own
- K060480: Vitros Immunodiagnostic Products Cortisol Reagent Pack and Calibrators and Metabolism Controls (2006), 0 descendants of its own

## Recalls of this device
- Feb 16, 2004 · Not classified · Z-0723-04: The package inserts contain incorrect control values for the urinary free cortisol extraction procedure.

Source page: https://510kreport.com/device/K854419
Methodology: https://510kreport.com/methodology