DeviceClearance

Product code NHG— Clinical Chemistry

Cortisol Saliva Luminescence Immunoassay

Classification name
Enzyme Immunoassay, Cortisol, Salivary
Device class
Class 2
Regulation
21 CFR 862.1205
Advisory panel
Clinical Chemistry
Total cleared
7
First cleared
Most recent

FDA classification definition

“The HS Salivary Cortisol Enzyme Immunoassay Kit is for the quantitative in vitro diagnostic measurement of salivary cortisol. This kit may be used to measure adrenal cortical function and as a screen for Cushing's and Addison's Disease. This kit is not intended for use with serum or plasma samples. The device's intended use differs from the description in the classification regulation in that it is for use with saliva samples.”

— U.S. Food and Drug Administration, device classification record for product code NHG under 21 CFR 862.1205, via openFDA

Market context for product code NHG

FDA has cleared 7 devices under product code NHG between 2001 and 2015, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code NHG

Recent clearances under product code NHG

Data sourced from openFDA. This site is unofficial and independent of the FDA.