Cleared Special

HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY

K031348 · Salimetrics, LLC · Chemistry

Jun 2003

Decision

60d

Days

Class 2

Risk

About This 510(k) Submission

K031348 is an FDA 510(k) clearance for the HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, a Enzyme Immunoassay, Cortisol, Salivary (Class II — Special Controls, product code NHG), submitted by Salimetrics, LLC (State College, US). The FDA issued a Cleared decision on June 10, 2003, 60 days after receiving the submission on April 11, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1205.

Submission Details

510(k) Number	K031348 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 11, 2003
Decision Date	June 10, 2003
Days to Decision	60 days
Submission Type	Special
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.