Cleared Traditional

ELECSYS CORTISOL TEST SYSTEM

K070788 · Roche Diagnostics · Chemistry

Oct 2007

Decision

197d

Days

Class 2

Risk

About This 510(k) Submission

K070788 is an FDA 510(k) clearance for the ELECSYS CORTISOL TEST SYSTEM, a Enzyme Immunoassay, Cortisol, Salivary (Class II — Special Controls, product code NHG), submitted by Roche Diagnostics (Indianapolos, US). The FDA issued a Cleared decision on October 5, 2007, 197 days after receiving the submission on March 22, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1205.

Submission Details

510(k) Number	K070788 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 22, 2007
Decision Date	October 05, 2007
Days to Decision	197 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.