Cleared Traditional

HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-0102

K011323 · Salimetrics, LLC · Chemistry

Dec 2001

Decision

230d

Days

Class 2

Risk

About This 510(k) Submission

K011323 is an FDA 510(k) clearance for the HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-0102, 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 December 17, 2001, 230 days after receiving the submission on May 1, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1205.

Submission Details

510(k) Number	K011323 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 01, 2001
Decision Date	December 17, 2001
Days to Decision	230 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.