Medical Devices

Nucleic Acid Based Tests

This is a list of nucleic acid-based tests that have been cleared or approved by the Center for Devices and Radiological Health. These tests analyze variations in the sequence, structure, or expression of deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) in order to diagnose disease or medical conditions, infection with an identifiable pathogen, and determine genetic carrier status.

This list excludes nucleic acid-based companion diagnostic tests. Those tests are listed at In Vitro Companion Diagnostic Devices.



List of Human Genetic Tests

DiseaseTrade NameManufacturerSubmission
Acute Myeloid LeukemiaVysis D7S486/CEP 7 FISH Probe KitAbbott Molecular Inc.K131508
Vysis EGR1 FISH Probe KitAbbott Molecular Inc.K123951, K091960
B-cell chronic lymphocytic leukemiaVysis CLL FISH Probe KitVysisK100015
CEP 12 SpectrumOrange Direct Labeled Chromosome Enumeration DNA ProbeVysisK962873
Bladder CancerVysis UroVysion Bladder Cancer Recurrence KitVysisK033982, K013785, K011031
Breast CancerProsigna Breast Cancer Prognostic Gene Signature AssayNanostring TechnologiesK130010
MammaPrintAgendia BVK101454, K081092, K080252, K070675, K062694
GeneSearch Breast Lymph Node (BLN) Test KitVeridex, LLC.P060017 S001-S004
Dako TOP2A FISH PharmDx KitDako Denmark A/SP050045 S001-S004
Cystic FibrosisIllumina MiSeqDx Cystic Fibrosis Clinical Sequencing AssayIllumina, IncK132750
Illumina MiSeqDx Cystic Fibrosis 139-Variant AssayIllumina, IncK124006
eSensor CF Genotyping TestOsmetech Molecular DiagnosticsK090901
xTAG Cystic Fibrosis 60 Kit v2Luminex Molecular Diagnostics Inc.K083845
xTAG Cystic Fibrosis 39 Kit v2Luminex Molecular Diagnostics Inc.K083846
Verigene CFTR and Verigene CFTR PolyT Nucleic Acid TestsNanosphere, IncK083294
InPlex CF Molecular TestThird Wave Technology, Inc.K063787
Cystic Fibrosis Genotyping AssayCelera DiagnosticsK062028
Tag-It Cystic Fibrosis KitTm Bioscience CorporationK060627, K043011
eSensor Cystic Fibrosis Carrier Detection SystemClinical Micro Sensors, Inc.K060543, K051435
Drug metabolizing enzymesxTAG CYP2D6 Kit v3Luminex Molecular Diagnostics, Inc.K130189, K093420
Spartan RX CYP2C19 Test SystemSpartan Bioscience, Inc.K123891
Verigene CYP2C 19 Nucleic Acid TestNanosphere, Inc.K120466
INFINITI CYP2C19 AssayAutoGenomics, Inc.K101683
Invader UGT1A1 Molecular AssayThird Wave Technologies Inc.K051824
Roche AmpliChip CYP450 microarrayRoche Molecular Systems, Inc.K043576, K042259
eSensor Warfarin Sensitivity Saliva TestGenMark DiagnosticsK110786
eQ-PCR LC Warfarin Genotyping kitTrimGen CorporationK073071
eSensor Warfarin Sensitivity Test and XT-8 InstrumentOsmetech Molecular DiagnosticsK073720
Gentris Rapid Genotyping Assay - CYP2C9 & VKORCIParagonDx, LLCK071867
INFINITI 2C9 & VKORC1 Multiplex Assay for WarfarinAutoGenomics, Inc.K073014
Verigene Warfarin Metabolism Nucleic Acid Test and Verigene SystemNanosphere, Inc.K070804
Coagulation FactorsInvader Factor VHologic, Inc.K100980
Invader Factor IIHologic, Inc.K100943
Illumina VeraCode Genotyping Test for Factor V and Factor IIIllumina, Inc.K093129
eSensor Thrombophilia Risk Test, eSensor FII-FV Genotyping Test, eSensor Fll Genotyping Test, eSensor FV Genotyping Test, eSensor MTHFR Genotyping TestOsmetech Molecular DiagnosticsK093974
Xpert HemosIL FII & FVCepheidK082118
Verigene F5 Nucleic Acid Test
Verigene F2 Nucleic Acid Test
Verigene MTHFR Nucleic Acid Test
Nanosphere, Inc.K070597
INFINITI SystemAutogenomics, Inc.K060564
Factor II (Prothrombin) G20210A KitRoche Diagnostics CorporationK033612
Factor V leiden KitRoche Diagnostics CorporationK033607
Invader MTHFR 677Hologic, Inc.K100987
Invader MTHFR 1298Hologic, Inc.K100496
Chromosome abnormalitiesAffymetrix CytoScan Dx AssayAffymetrix, Inc.K130313
AneuVysionVysisK010288, K972200
CEP 8 Spectrumorange DNA Probe KitVysisK953591
CEP X SpectrumOrange/ Y SpectrumGreen DNA Probe KitVysisK954214
Heart TransplantAlloMap Molecular Expression TestingxDxK073482
Prostate CancerNADiA ProsVueIris Molecular DiagnosticsK101185
PROGENSA PCA3 AssayGen-Probe, Inc.P100033
Tissue of OriginPathwork Tissue of Origin Test Kit – FFPEPathwork Diagnostics Inc.K120489, K092967
Pathwork Tissue of Origin TestPathwork Diagnostics Inc.K080896

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List of Microbial Tests

MicroorganismTrade NameManufacturerSubmission
AdenovirusAdenovirus R-gene USArgene SAK121942
ProAdeno+ AssayGen-Probe Prodesse, Inc.K102952
Bacillus Anthracis JBAIDS Anthrax Detection SystemIdaho Technology, Inc.K131930, K071188, K051713
Candida tropicalis /
Candida albicans /
Candida parapsilosis /
Candida glabrata /
Candida krusei
 
Affirm VPIII Microbial Identification TestMicroprobe Corp.K931151, K931374
Yeast Traffic Light PNA FISHAdvanDx, Inc.K093024, K080719
C. albicans / C. glabrata PNA FISHAdvanDx, Inc.K092784
C. albicans PNA FISHAdvanDx, Inc.K092655, K062461
C. Albicans screenCarr-Scarborough Microbiologicals, Inc.K891476
Clostridium difficile ICEPlex C. difficile KitPrimeraDxK132726
IMDx C. difficile for Abbott m2000Intelligent Medical Devices, Inc.K132235
BD Diagnostics BD MAX Cdiff AssayGeneOhm Sciences Canada Inc.K130470
Quidel Molecular Direct C. difficile AssayQuidel CorporationK123998
Verigene C. Difficile Nucleic acid TestNanosphere, Inc.K123197
Portrait Toxigenic C. difficile AssayGreat Basin Scientific, Inc.K113358
Simplexa C. difficile Universal Direct AssayFocus Diagnostics, Inc.K113433
Xpert C. difficile/EpiCepheidK110203
Illumigene C. difficile DNA Amplification AssayMeridian Bioscience, Inc.K110012
Illumigene C. difficile AssayMeridian Bioscience, Inc.K100818
Xpert C. difficileCepheidK091109
ProGastro Cd AssayProdesse Inc.K090239
BD GeneOhm C. diff AssayBD Diagnostics/ GeneOhm Sciences, Inc.K081920
Coxiella burnetiiJoint Biological Agent Identification and Diagnostic System (JBAIDS) Q Fever Detection KitIdaho Technology, Inc.K103207
Chlamydia trachomatis /
Neisseria gonorrhoeae
Aptima Combo 2 AssayHologic/Gen-Probe, Inc.K132251
Xpert Ct/NgCepheidK121710
Aptima Combo 2 Assay (Panther System)Gen-Probe, Inc.K111409
Cobas CT/NG TestRoche Molecular Systems, Inc.K132270, K110923
Abbott RealTime CT/NG and Multi-Collect Specimen Collection KitAbbott Molecular Inc.K092704, K080739
BD ProbeTec Chlamydia trachomatis (CT) Qx Amplified DNA AssayBecton, Dickinson, & Co.K091724, K090824, K081824
AMPLICOR CT/NG Test for Chlamydia trachomatisRoche Diagnostics Corp.K070174, K973707
Gen-Probe Aptima for Chlamydia TrochamatisGen-Probe, Inc.K063451, K053446, K043072
TIGRIS DTS Automated Analyzer Aptima Assay for Chlamydia trachomatisGen-Probe, Inc.K061413
TIGRIS DTS Gen-Probe Aptima Combo 2 AssayGen-Probe, Inc.K060652
Cobas Amplicor CT/NG test for Chlamydia trachomatisRoche Molecular Systems, Inc.K053287, K973718
GEN-PROBE Aptima Combo 2 AssayGen-Probe, Inc.K043224, K032554,
BDProbeTec ET Chlamydia trachomatis and Neisseria gonorrhoeae Amplified DNA AssaysBecton, Dickinson, & Co.K012351, K003395, K984631
Roche Cobas AMPLICOR Chlamydia trachomatis testRoche Molecular Systems, Inc.K964507
Gen-Probe AMPLIFIED Chlamydia trachomatis Assay KitGen-Probe, Inc.K962217
LCX Chlamydia trachomatis AssayAbbott LaboratoriesK934622
BD Probetec Neisseria Gonorrhoeae (GC) Qx Amplified DNA AssayBecton, Dickinson, & Co.K091730, K090971, K090827, K081825
AMPLICOR CT/NG Test for Neisseria GonorrhoeaeRoche Diagnostics Corp.K070172
Gen-Probe Aptima Assay for Neisseria GonorrhoeaeGen-Probe, Inc.K063664, K062440
Tigris DTS Gen-Probe Aptima Assay for Neisseria GonorrhoeaeGen-Probe, Inc.K061509
COBAS Amplicor CT/NG test for Neisseria gonorrhoeaeRoche Molecular Systems, Inc.K053289, K974342
Hybrid Capture II CT/GC DNA TestDigene Corp.K981567
Roche AMPLICOR CT/NG test for Neisseria gonorrhoeaeRoche Molecular Systems, Inc.K974503
Digene GC-ID Test Hybrid Capture IIDigene Corp.K981485
Gen-Probe PACE 2C System Chlamydia Trachomatis / Neisseria gonorrhoeaeGen-Probe, Inc.K940979
PACE2 Neisseria gonorrhoeae probe confirmation assayGen-Probe, Inc.K920301
GONOSTAT Gonococcal Detection KitSierra Diagnostics, Inc.K991268
LCX Neisseria gonorrhoeae AssayAbbott LaboratoriesK935833
CytomegalovirusCOBAS AmpliPrep/COBAS TaqMan CMV TestRoche Molecular SystemsP110037
S001-S002
NucliSens CMV pp67Organon Teknika CorporationK983762
Dengue virusCDC DENV-1-4 Real-Time RT-PCR AssayCenters for Disease Control and PreventionK113336
EntercoccusIMDx Van R for Abbott m2000Intelligent Medical Devices, Inc.K123753
BD GeneOhm VanR AssayBD Diagnostics (GeneOhm Sciences, Inc.)K102416
Xpert vanA AssayCepheidK092953
E. faecalis/OE PNAAdvanDx, Inc.K083074
GBS PNA FISHAdvanDx, Inc.K082612
E. faecalis PNA FISH culture identification kitAdvanDx, Inc.K063127
EnterovirusNucliSens EasyQ Enterovirus vl.1 AssaybioMérieux, Inc.K093383, K063261
Escherichia coli /
Klebsiella pneumoniae /
Pseudomonas aeroginosa
GNR Traffic Light PNA FISHAdvanDx, Inc.K101558
E. coli/P. aeruginosa PNA FISHAdvanDx, Inc.K092236, K081309
EK/P aeruginosa PNA FISHAdvanDx, Inc.K092393, K081433
E. coli PNA FISHAdvanDx, Inc.K082068
Francisella tularensisJBAIDS Tularemia Detection KitIdaho Technology, Inc.K072547
Gram-Positive /
Gram-Negative Bacteria
Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP)Nanosphere, Inc.K122514 , K113450
Herpes Simplex VirusIsoAmp HSV AssayBioHelix CorporationK111951
MultiCode-RTx Herpes Simplex Virus 1 & 2 KitEraGen Biosciences, Inc.K111527 , K100336
BD ProbeTec Herpes Simplex Viruses (HSV I & 2) QX Amplified DNA AssaysBD Diagnostic SystemsK103798
Hepatitis virusAbbott RealTime HCV Genotype IIAbbott Molecular, Inc.P120012
Abbott Realtime HCV AssayAbbott Molecular, Inc.P100017 S001-S006
Abbott Realtime HBV AssayAbbott Molecular, Inc.P080026 S001-S004
COBAS AmpliPrep/COBAS TaqMan HCV testRoche Molecular SystemsP060030 S001-S032
COBAS Taqman HBV TestRoche Molecular Systems, Inc.P050028 S001-S027
Versant HCV 3.0 Assay (bDNA)Siemens Healthcare DiagnosticsP020022
Versant HCV RNA Qualitative AssayGen-Probe, Inc.P020011 S001-S007
COBAS AMPLICOR Hepatitis C Virus (HCV) TestRoche Molecular Systems, Inc.P000012 S001-S043
AMPLICOR HCV Test, v2.0Roche Molecular Systems, Inc.P000010 S001-S024
Human MetapneumovirusQuidel Molecular RSV + hMPV AssayQuidel CorporationK131813, K122189
Quidel Molecular hMPV AssayQuidel CorporationK112490
Pro hMPV+ AssayProdesse, Inc.K132200, K082688
Human papillomavirusAptima HPV AssayGen-Probe, Inc.P100042
COBAS HPV TestRoche Molecular Systems, Inc.P100020 S001-S005
Aptima HPV 16 18/45 Genptype AssayGen-Probe, Inc.P120007
Cervista HPV 16/18Hologic, Inc.P080015 S001-S016
Cervista HPV HR and Genfind DNA Extraction KitHologic, Inc.P080014 S001-S013
Digene Hybrid Capture 2 High-Risk HPV DNA TestDigene CorporationP890064 S001-S027
Influenza and Respiratory Viruses Prodesse ProFAST AssatGen-Probe Prodesse, Inc.K132237
Quidel Molecular Influenza A + B AssayQuidel CorporationK131728, K113777, K112172
IMDx Flu A/B and RSV for Abbott m2000Intelligent Medical Devices, Inc.K131584
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic PanelCenters for Disease Control and PreventionK133869, K132508, K130551, K123905, K111507
Prodesse ProParaflu AssayGen-Probe Prodesse, Inc.K132238, K091053
Xpert Flu AssayCepheidK123191, K120911, K103766
Simplexa Flu A/B & RSV DirectFocus Diagnostics, Inc.K120413
FilmArray Respiratory Panel (RP)Idaho Technology, Inc.K123620, K120267, K110764, K103175
artus Infl A/B RG RT-PCR KitQiagen GmbHK113323
xTAG Respiratory Viral Panel (RVP)Luminex Molecular Diagnostics, Inc.K112781, K112199, K091667, K081483, K063765
JBAIDS Influenza A Subtyping KitU.S. Army Medical Materiel Development ActivityK111778
JBAIDS Influenza A&B Detection KitU.S. Army Medical Materiel Development ActivityK111775
eSensor Respiratory Viral Panel (RVP)GenMark DiagnosticK113731
Liat Influenza A/B AssayIQuum, Inc.K111387
ProFlu+ AssayGen-Probe Prodesse, Inc.K132129, K110968, K092500, K081030, K073029
xTAG Respiratory Viral Panel Fast (RVP FAST)Luminex Molecular Diagnostics, Inc.K103776
Verigene Respiratory Virus Plus Nucleic Acid Test (RV+)Nanosphere, Inc.K103209, K093337, K092957, K092566, K083088
Simplexa Flu A/B & RSVFocus Diagnostics, Inc.K102170
CDC Influenza 2009 A (H1N1) pdm Real-Time RT-PCR PanelCenters for Disease Control and PreventionK101564
JBAIDS Influenza A/H5 (Asian lineage) Detection KitU.S. Army Medical Materiel Development ActivityK100287
Simplexa Influenza A H1N1 (2009)Focus Diagnostics, Inc .K100148
CDC Human Influenza Virus Real-time RT-PCR Detection and Characterization PanelCenters for Disease Control and PreventionK080570
Influenza A/H5 (Asian lineage) Virus Real-time RT-PCR Primer and Probe SetCenters for Disease Control and PreventionK060159
Leishmania speciesSMART LeishU.S. Army Medical Materiel Development ActivityK081868
Mycobacterium tuberculosis Xpert MTB/RIF AssayCepheidK131706
BDProbetec ET Mycobacterium tuberculosis complex culture identification kitBecton, Dickinson, & Co.K000884
Amplified Mycobacterium tuberculosis Direct TestGen-Probe, Inc.P940034
Amplicor Mycobacterium tuberculosis testRoche Molecular Systems, Inc.P940040
SNAP M.tuberculosis complexSyngene, Inc.K900292
Accuprobe Mycobacterium tuberculosis complex TestGen-Probe, Inc.K896493
Rapid Diagnostic System for Mycobacterium tuberculosisGen-Probe, Inc.K871795
Rapid Identification Test for Mycobacterium tuberculosis complexGen-Probe, Inc.K862614
Mycobacterium species Accuprobe Mycobacterium avium complex cultureGen-Probe, Inc.K921435, K896494, K897078
Accuprobe Mycobacterium kansasii Identification TestGen-Probe, Inc.K904463
SNAP Mycobacterium avium complexSyngene, Inc.K900202
Accuprobe Mycobacterium intracellulare Culture Identification TestGen-Probe, Inc.K897077
Accuprobe Mycobacterium gordonae culture identification TestGen-Probe, Inc.K896492
Rapid Diagnostic System for Mycobacterium gordonaeGen-Probe, Inc.K890089
Rapid Diagnostic System for MycobacteriaGen-Probe, Inc.K864597
Rapid Identification Test for Mycobacterium aviumGen-Probe, Inc.K862613
Gen-Probe Mycobacterium Rapid Confirmation SystemGen-Probe, Inc.K860782
Mycoplasma pneumoniaeIllumigene Mycoplasma DNA Amplification AssayMeridian Bioscience, Inc.K123423
Multiplex PanelProGastro SSCS AssayGen-Probe Prodesse, Inc.K123274
xTAG Gastrointestinal Pathogen Panel (GPP)Luminex Molecular Diagnostics, Inc.K121894, K121454
Staphylococcus BD Max MRSA AssayBD Diagnostics (GeneOhm Sciences Canada, Inc.)K120138
Staphylococcus QuickFISH BCAdvanDx, Inc.K113371
MRSA/SA ELITe MGBEliTechGroup Epoch Biosciences.K112937
Verigene Staphylococcus Blood Culture (BC-S) Nucleic Acid TestNanosphere, Inc.K112424
NucliSENS EasyQ MRSA AssaybioMerieux, Inc.K102740
Xpert MRSA/SA Blood Culture AssayCepheidK101879, K082140
Xpert MRSA/SA Nasal Complete AssayCepheidK100822
LightCycler MRSA Advanced TestRoche Molecular Systems, IncK091409
BD GeneOhm MRSA ACP AssayBD Diagnostics (GeneOhm Sciences Canada, Inc.)K093346
S. aureus and/or other Staphylococcus species PNA FISH CultureAdvanDx, Inc.K092166
Xpert MRSA/SA SSTI AssayCepheidK080837
BD GeneOhM StaphSR AssayBD Diagnostics (GeneOhm Sciences Canada, Inc.)K071026
S. aureus PNA FISHAdvanDx, Inc.K091827, K060099
Xpert MRSACepheidK070462
IDI-MRSA AssayInfectio Diagnostic, Inc.K042357, K033415
Streptococci Xpert GBS LB AssayCepheidK121539
illumigene Group A Streptococcus (GBS) DNA Amplification AssayMeridian Bioscience, Inc.K122019
illumigene Group B Streptococcus (GBS) DNA Amplification AssayMeridian Bioscience, Inc.K121044
BD Max GBS AssayBecton, Dickinson, & Co.K111860
Cepheid Smart GBS AssayCepheidK062948
Xpert GBSCepheidK060540
IDI-Strep B AssayInfectio Diagnostic, Inc.K022504
Gen-Probe Accuprobe Group B Streptococcus culture identification kitChugai Pharmaceuticals Co, Ltd.K974572
Accuprobe Streptococcus pneumoniae culture confirmationGen-Probe, Inc.K902908
Trichomonas vaginalis Aptima Trichomonas vaginalis assayGen-Probe, Inc.K102911
Affirm/VP Identification Test G. Vaginalis and T. vaginalisMicroprobe Corp.K923133
Yersinia pestisJBAIDS Plague Detection KitIdaho Technology, Inc.K072631

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Page Last Updated: 06/17/2014
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