NHG · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.1205
Classification
FDA Product Code
NHG
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 862.1205
Review panel
CH
Medical specialty
Clinical Chemistry
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
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.