Cleared Traditional

Cortisol Saliva Luminescence Immunoassay

K150528 · Ibl International GmbH · Chemistry

Nov 2015

Decision

268d

Days

Class 2

Risk

About This 510(k) Submission

K150528 is an FDA 510(k) clearance for the Cortisol Saliva Luminescence Immunoassay, a Enzyme Immunoassay, Cortisol, Salivary (Class II — Special Controls, product code NHG), submitted by Ibl International GmbH (Hamburg, DE). The FDA issued a Cleared decision on November 25, 2015, 268 days after receiving the submission on March 2, 2015. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1205.

Submission Details

510(k) Number	K150528 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 02, 2015
Decision Date	November 25, 2015
Days to Decision	268 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

Product Code	NHG — Enzyme Immunoassay, Cortisol, Salivary
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.1205
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.