Cleared Special

PRODESSE PROFAST+ ASSAY

K132237 · Gen-Probe Prodesse, Inc. · Microbiology

Aug 2013

Decision

39d

Days

Class 2

Risk

About This 510(k) Submission

K132237 is an FDA 510(k) clearance for the PRODESSE PROFAST+ ASSAY, a 2009 H1n1 Influenza Virus (swine Origin), Nucleic Acid Or Antigen, Detection And Identification (Class II — Special Controls, product code OQW), submitted by Gen-Probe Prodesse, Inc. (Waukesha, US). The FDA issued a Cleared decision on August 26, 2013, 39 days after receiving the submission on July 18, 2013. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3332.

Submission Details

510(k) Number	K132237 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 18, 2013
Decision Date	August 26, 2013
Days to Decision	39 days
Submission Type	Special
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	OQW — 2009 H1n1 Influenza Virus (swine Origin), Nucleic Acid Or Antigen, Detection And Identification
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3332
Definition	2009 H1n1 Influenza Virus Detection And Identification Reagents Are Used To Directly Detect And Differentiate The 2009 H1n1 Influenza Virus In Human Respiratory Specimens