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510(k) K243625

Device
Xpert MRSA/SA SSTI
Applicant
Cepheid®
510(k) number
K243625
Product code
NQX
Decision
Substantially Equivalent (SESE)
Decision date
2024-12-18
Date received
2024-11-25
Regulation
866.1640
Classification name
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Special
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 NQX#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243070Xpert® SA Nasal CompleteCepheid®2024-10-25
K191742ARIES MRSA AssayLuminex Corporation2019-09-25
K190771Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 SystemCepheid2019-04-25
K162444Xpert MRSA NxGCepheid2016-11-23
K142721cobas MRSA/SA TestRoche Molecular Systems, Inc.2014-12-17
K133605BD MAX MRSA XT, BD MAX INSTRUMENTGeneohm Sciences Canada, Inc.2013-12-20
K132822BD MAX STAPHSR ASSAY, INSTRUMENTGeneohm Sciences Canada, Inc. (Bd Diagnostics)2013-11-26
K132468MRSA/SA ELITE MGB, ELITE MGB SOFTWAREElitechgroup Epoch Biosciences2013-10-17
K130894XPERT MRSA/SA BLOOD CULTURE ASSAY; GENEXPERT DX SYSTEMS (GX-I, GX-II, GX-IV, GX-XVI); GENEXPERT INFINITY-48 SYSTEM; GENECepheid2013-06-20
K120138BD MAX MRSA ASSAY, BD MAX INSTRUMENTBd Diagnostics (Geneohm Sciences Canada, Inc)2012-07-05
K112937MRSA/SA ELITE MGBElitech2012-06-01
K112424VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S)Nanosphere, Inc.2011-12-16
K102740NUCLISENS EASYQ MRSA; NUCLISENS EASYQ ANALYZER; NUCLISENS EASYQ INCUBATOR (110 VOLT); NUCLISENS DIRECTOR V.2.6bioMerieux, Inc.2011-05-20
K101879XPERT MRSA/SA BC (BLOOD CULTURE) ASSAY MODEL GXMRSA/SA-BC-10Cepheid2010-07-28
K091409LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT, MODEL 05205727Roche Molecular Systems, Inc.2010-07-06