Cleared Traditional

XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOFTWARE VERISIONS 2.1 AND 4.0

K103766 · Cepheid · Microbiology

Apr 2011

Decision

119d

Days

Class 2

Risk

About This 510(k) Submission

K103766 is an FDA 510(k) clearance for the XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOFTWARE VERISIONS 2.1 AND 4.0, a 2009 H1n1 Influenza Virus (swine Origin), Nucleic Acid Or Antigen, Detection And Identification (Class II — Special Controls, product code OQW), submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on April 21, 2011, 119 days after receiving the submission on December 23, 2010. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3332.

Submission Details

510(k) Number	K103766 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 23, 2010
Decision Date	April 21, 2011
Days to Decision	119 days
Submission Type	Traditional
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