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

FDA 510(k) clearance K103766 · decided 2011-04-21

Clearance details

K-number: K103766
Device name: XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOFTWARE VERISIONS 2.1 AND 4.0
Applicant: Cepheid
Decision: Substantially Equivalent
Date received: 2010-12-23
Decision date: 2011-04-21
Days to decision: 119 days
Clearance type: Traditional
Product code: OQW
Device class: 2
Regulation number: 866.3332
Medical specialty: Microbiology
Advisory committee: Microbiology
Location: Sunnyvale, CA, US
Third-party review: No
Expedited review: No

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Devices cleared under the same product code - the starting set for predicate research.

Record	Firm	Date
PRODESSE PROFAST+ ASSAY (K132237)	Gen-Probe Prodesse, Inc.	2013-08-26
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL (K130551)	Centers for Disease Control and Prevention	2013-05-22
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL (K123905)	Centers for Disease Control and Prevention	2013-01-14
XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV) (K120911)	Cepheid	2012-05-18
JBAIDS INFLUENZA A SUBTYPING KIT (K111778)	U.S Army Medical Materiel Development Activity	2011-09-13
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL (K111507)	Centers for Disease Control and Prevention	2011-08-23
PROFAST+ ASSAY (K101855)	Gen-Probe Prodesse, Inc.	2010-07-23
CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL (K101564)	Centers for Disease Control and Prevention	2010-06-22
SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500 (K100148)	Focus Diagnostics, Inc.	2010-05-24

Record	Firm	Date
Xpert Infinity Software, V 4.1a. Cepheid, Sunnyvale, CA 94089 system software for GeneXper recall (Z-2401-2011)	Cepheid	2011-05-31