Cleared Traditional

ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE

K043175 · Roche Diagnostics Corp. · Chemistry

Nov 2004

Decision

Days

Class 2

Risk

About This 510(k) Submission

K043175 is an FDA 510(k) clearance for the ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE, a Enzyme Immunoassay, Cortisol, Salivary (Class II — Special Controls, product code NHG), submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on November 24, 2004, 8 days after receiving the submission on November 16, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1205.

Submission Details

510(k) Number	K043175 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 16, 2004
Decision Date	November 24, 2004
Days to Decision	8 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.