# K931409: Immulite Cortisol

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: May 11, 1993 after 53 days
- Product code: CGR (Radioimmunoassay, 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; 2 cite 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
- K202826: IMMULITE® 2000 Cortisol (2021), 0 descendants of its own
- K203270: IMMULITE/IMMULITE® 1000 Cortisol (2021), 0 descendants of its own

## Recalls of this device
- Sep 19, 2014 · Class II · Z-0122-2015: Customer complaints were received for positive bias reported on the controls used on the IMMULITE /IMMULITE 1000 on the Cortisol Assay reagent lots IMMULITE /IMMULITE 1000 (LKCO1) Lots 381,382 and 383

Source page: https://510kreport.com/device/K931409
Methodology: https://510kreport.com/methodology