Cleared Traditional

PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY

K102841 · Pantex, Div. Bio-Analysis, Inc. · Chemistry

May 2012

Decision

587d

Days

Class 2

Risk

About This 510(k) Submission

K102841 is an FDA 510(k) clearance for the PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY, a Enzyme Immunoassay, Cortisol, Salivary (Class II — Special Controls, product code NHG), submitted by Pantex, Div. Bio-Analysis, Inc. (Santa Monica, US). The FDA issued a Cleared decision on May 8, 2012, 587 days after receiving the submission on September 29, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1205.

Submission Details

510(k) Number	K102841 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 29, 2010
Decision Date	May 08, 2012
Days to Decision	587 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.