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510(k) K222638

Device
Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems
Applicant
Cepheid
510(k) number
K222638
Product code
NJR
Decision
Substantially Equivalent (SESE)
Decision date
2023-09-27
Date received
2022-09-01
Regulation
866.3740
Classification name
Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Suzette Chance
Address
904 Caribbean Dr. Sunnyvale CA US 94089 94089

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NJR#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K203429Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity SystemCepheid2022-05-09
K182467Simplexa GBS Direct, Simplexa GBS Positive Control PackDiasorin Molecular, LLC2018-11-07
K181156Panther Fusion GBS AssayDiagenode2018-07-27
K173725NeuMoDx GBS AssayNeumodx Molecular, Inc.2018-06-26
K173250Solana GBS AssayQuidel Corporation2017-12-21
K170557GenePOC GBS LBGenepoc, Inc.2017-05-25
K162772ARIES GBS AssayLuminex Corporation2016-12-23
K143312Portrait GBS AssayGreat Basin Corporation2015-04-21
K133503AMPLIVUE GBS ASSAYQuidel Corporation2013-12-20
K121539XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GENEXPERT INFINITY-48 SYSTEM (900-XXXX)Cepheid2012-11-02
K121044ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIMMeridian Bioscience, Inc.2012-05-01
K111860BD MAX GBS ASSAY, BD MAX INSTRUMENTBecton, Dickinson & CO2012-02-16
K112125ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KITMeridian Bioscience, Inc.2011-12-05
K090191HANDYLAB GBS ASSAY, HANDYLAB JAGUAR INSTRUMENT, HANDYLAB DNA EXTRACTION STRIP, HANDYLAB E3 EXTRACTION REAGENT, HANDYLABHandylab, Inc.2010-05-27
K062948SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7BCepheid2006-12-08