Cleared Traditional

ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL

K051733 · Drg Intl., Inc. · Chemistry

Dec 2005

Decision

162d

Days

Class 2

Risk

About This 510(k) Submission

K051733 is an FDA 510(k) clearance for the ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL, a Enzyme Immunoassay, Cortisol, Salivary (Class II — Special Controls, product code NHG), submitted by Drg Intl., Inc. (East Stroudsburg, US). The FDA issued a Cleared decision on December 7, 2005, 162 days after receiving the submission on June 28, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1205.

Submission Details

510(k) Number	K051733 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 28, 2005
Decision Date	December 07, 2005
Days to Decision	162 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.