# K052359: Ibl Cortisol Lia Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: Lehnus & Associates Consulting
- Decided: Oct 3, 2005 after 38 days
- Product code: CGR (Radioimmunoassay, 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The IBL Cortisol Luminescence Immunoassay is for the in-vitro-diagnostic quantitative determination of cortisol in human serum and saliva. The Cortisol LIA kit is useful as an aid in the differential diagnosis of Cushing syndrome and Addison's disease.

Source page: https://510kreport.com/device/K052359
Methodology: https://510kreport.com/methodology