# K150528: Cortisol Saliva Luminescence Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Ibl International GmbH
- Decided: Nov 25, 2015 after 268 days
- Product code: NHG (Enzyme Immunoassay, Cortisol, Salivary)
- 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: 2 generations back to K011323 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102841: Pantex AM/PM Salivary Cortisol Enzyme Immunoassay, Pantex, Div. Bio-Analysis, Inc. (2012) Summary page 5.

## Recalls of this device
- Jan 12, 2018 · Class II · Z-2923-2018: Product is not meeting specification for traceability to NIST cortisol standard, generating 1.3-1.8 times higher cortisol values with laboratory samples in comparison to NIST cortisol standard.

## Indications for use
The IBL International Cortisol Saliva Luminescence Immunoassay is intended for the in-vitro diagnostic quantitative determination of Cortisol in human saliva and for use as an aid in the diagnosis and treatment of adrenal disorders. The device is not intended for point-of-care settings.

Source page: https://510kreport.com/device/K150528
Methodology: https://510kreport.com/methodology