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

Disease Trade Name Manufacturer Submission
Acute Myeloid Leukemia Vysis D7S486/CEP 7 FISH Probe Kit Abbott Molecular Inc. K131508
Vysis EGR1 FISH Probe Kit Abbott Molecular Inc. K123951, K091960
B-cell chronic lymphocytic leukemia Vysis CLL FISH Probe Kit Vysis K100015
CEP 12 SpectrumOrange Direct Labeled Chromosome Enumeration DNA Probe Vysis K962873
Bladder Cancer Vysis UroVysion Bladder Cancer Recurrence Kit Vysis K033982, K013785, K011031
Breast Cancer Prosigna Breast Cancer Prognostic Gene Signature Assay Nanostring Technologies K130010
MammaPrint Agendia BV K101454, K081092, K080252, K070675, K062694
INFORM HER2 Dual ISH DNA Probe Cocktail Ventana Medical Systems, Inc. P100027
HER2 CISH pharmDxTM Kit Dako Denmark A/S P100024
GeneSearch Breast Lymph Node (BLN) Test Kit Veridex, LLC. P060017 S001-S004
Dako TOP2A FISH PharmDx Kit Dako Denmark A/S P050045 S001-S004
  DakoCytomation Her2 FISH pharmDx™ Kit DakoCytomation Denmark A/S P040005
Colorectal Cancer Cologuard Exact Sciences Corporation P130017
Cystic Fibrosis Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay Illumina, Inc K132750
Illumina MiSeqDx Cystic Fibrosis 139-Variant Assay Illumina, Inc K124006
eSensor CF Genotyping Test Osmetech Molecular Diagnostics K090901
xTAG Cystic Fibrosis 60 Kit v2 Luminex Molecular Diagnostics Inc. K083845
xTAG Cystic Fibrosis 39 Kit v2 Luminex Molecular Diagnostics Inc. K083846
Verigene CFTR and Verigene CFTR PolyT Nucleic Acid Tests Nanosphere, Inc K083294
InPlex CF Molecular Test Third Wave Technology, Inc. K063787
Cystic Fibrosis Genotyping Assay Celera Diagnostics K062028
Tag-It Cystic Fibrosis Kit Tm Bioscience Corporation K060627, K043011
eSensor Cystic Fibrosis Carrier Detection System Clinical Micro Sensors, Inc. K060543, K051435
Drug metabolizing enzymes xTAG CYP2D6 Kit v3 Luminex Molecular Diagnostics, Inc. K130189, K093420
Spartan RX CYP2C19 Test System Spartan Bioscience, Inc. K123891
Verigene CYP2C 19 Nucleic Acid Test Nanosphere, Inc. K120466
INFINITI CYP2C19 Assay AutoGenomics, Inc. K101683
Invader UGT1A1 Molecular Assay Third Wave Technologies Inc. K051824
Roche AmpliChip CYP450 microarray Roche Molecular Systems, Inc. K043576, K042259
eSensor Warfarin Sensitivity Saliva Test GenMark Diagnostics K110786
eQ-PCR LC Warfarin Genotyping kit TrimGen Corporation K073071
eSensor Warfarin Sensitivity Test and XT-8 Instrument Osmetech Molecular Diagnostics K073720
Gentris Rapid Genotyping Assay - CYP2C9 & VKORCI ParagonDx, LLC K071867
INFINITI 2C9 & VKORC1 Multiplex Assay for Warfarin AutoGenomics, Inc. K073014
Verigene Warfarin Metabolism Nucleic Acid Test and Verigene System Nanosphere, Inc. K070804
Coagulation Factors Invader Factor V Hologic, Inc. K100980
Invader Factor II Hologic, Inc. K100943
Illumina VeraCode Genotyping Test for Factor V and Factor II Illumina, Inc. K093129
eSensor Thrombophilia Risk Test, eSensor FII-FV Genotyping Test, eSensor Fll Genotyping Test, eSensor FV Genotyping Test, eSensor MTHFR Genotyping Test Osmetech Molecular Diagnostics K093974
Xpert HemosIL FII & FV Cepheid K082118
Verigene F5 Nucleic Acid Test
Verigene F2 Nucleic Acid Test
Verigene MTHFR Nucleic Acid Test
Nanosphere, Inc. K070597
INFINITI System Autogenomics, Inc. K060564
Factor II (Prothrombin) G20210A Kit Roche Diagnostics Corporation K033612
Factor V leiden Kit Roche Diagnostics Corporation K033607
Invader MTHFR 677 Hologic, Inc. K100987
Invader MTHFR 1298 Hologic, Inc. K100496
Chromosome abnormalities Affymetrix CytoScan Dx Assay Affymetrix, Inc. K130313
AneuVysion Vysis K010288, K972200
CEP 8 Spectrumorange DNA Probe Kit Vysis K953591
CEP X SpectrumOrange/ Y SpectrumGreen DNA Probe Kit Vysis K954214
Heart Transplant AlloMap Molecular Expression Testing xDx K073482
Ovarian Cancer BRACAnalysis CDx Myriad Genetic Laboratories, Inc. P140020
Prostate Cancer NADiA ProsVue Iris Molecular Diagnostics K101185
PROGENSA PCA3 Assay Gen-Probe, Inc. P100033
Tissue of Origin Pathwork Tissue of Origin Test Kit – FFPE Pathwork Diagnostics Inc. K120489, K092967
Pathwork Tissue of Origin Test Pathwork Diagnostics Inc. K080896

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List of Microbial Tests

Microorganism Trade Name Manufacturer Submission
Adenovirus Adenovirus R-gene US Argene SA K121942
ProAdeno+ Assay Gen-Probe Prodesse, Inc. K102952
Bacillus Anthracis JBAIDS Anthrax Detection System Idaho Technology, Inc. K131930, K071188, K051713
Candida tropicalis /
Candida albicans /
Candida parapsilosis /
Candida glabrata /
Candida krusei
 
Affirm VPIII Microbial Identification Test Microprobe Corp. K931151, K931374
Yeast Traffic Light PNA FISH AdvanDx, Inc. K093024, K080719
C. albicans / C. glabrata PNA FISH AdvanDx, Inc. K092784
C. albicans PNA FISH AdvanDx, Inc. K092655, K062461
C. Albicans screen Carr-Scarborough Microbiologicals, Inc. K891476
Clostridium difficile ICEPlex C. difficile Kit PrimeraDx K132726
IMDx C. difficile for Abbott m2000 Intelligent Medical Devices, Inc. K132235
BD Diagnostics BD MAX Cdiff Assay GeneOhm Sciences Canada Inc. K130470
Quidel Molecular Direct C. difficile Assay Quidel Corporation K123998
Verigene C. Difficile Nucleic acid Test Nanosphere, Inc. K123197
Portrait Toxigenic C. difficile Assay Great Basin Scientific, Inc. K113358
Simplexa C. difficile Universal Direct Assay Focus Diagnostics, Inc. K113433
Xpert C. difficile/Epi Cepheid K110203
Illumigene C. difficile DNA Amplification Assay Meridian Bioscience, Inc. K110012
Illumigene C. difficile Assay Meridian Bioscience, Inc. K100818
Xpert C. difficile Cepheid K091109
ProGastro Cd Assay Prodesse Inc. K090239
BD GeneOhm C. diff Assay BD Diagnostics/ GeneOhm Sciences, Inc. K081920
Coxiella burnetii Joint Biological Agent Identification and Diagnostic System (JBAIDS) Q Fever Detection Kit Idaho Technology, Inc. K103207
Chlamydia trachomatis /
Neisseria gonorrhoeae
Aptima Combo 2 Assay Hologic/Gen-Probe, Inc. K132251
Xpert Ct/Ng Cepheid K121710
Aptima Combo 2 Assay (Panther System) Gen-Probe, Inc. K111409
Cobas CT/NG Test Roche Molecular Systems, Inc. K132270, K110923
Abbott RealTime CT/NG and Multi-Collect Specimen Collection Kit Abbott Molecular Inc. K092704, K080739
BD ProbeTec Chlamydia trachomatis (CT) Qx Amplified DNA Assay Becton, Dickinson, & Co. K091724, K090824, K081824
AMPLICOR CT/NG Test for Chlamydia trachomatis Roche Diagnostics Corp. K070174, K973707
Gen-Probe Aptima for Chlamydia Trochamatis Gen-Probe, Inc. K063451, K053446, K043072
TIGRIS DTS Automated Analyzer Aptima Assay for Chlamydia trachomatis Gen-Probe, Inc. K061413
TIGRIS DTS Gen-Probe Aptima Combo 2 Assay Gen-Probe, Inc. K060652
Cobas Amplicor CT/NG test for Chlamydia trachomatis Roche Molecular Systems, Inc. K053287, K973718
GEN-PROBE Aptima Combo 2 Assay Gen-Probe, Inc. K043224, K032554,
BDProbeTec ET Chlamydia trachomatis and Neisseria gonorrhoeae Amplified DNA Assays Becton, Dickinson, & Co. K012351, K003395, K984631
Roche Cobas AMPLICOR Chlamydia trachomatis test Roche Molecular Systems, Inc. K964507
Gen-Probe AMPLIFIED Chlamydia trachomatis Assay Kit Gen-Probe, Inc. K962217
LCX Chlamydia trachomatis Assay Abbott Laboratories K934622
BD Probetec Neisseria Gonorrhoeae (GC) Qx Amplified DNA Assay Becton, Dickinson, & Co. K091730, K090971, K090827, K081825
AMPLICOR CT/NG Test for Neisseria Gonorrhoeae Roche Diagnostics Corp. K070172
Gen-Probe Aptima Assay for Neisseria Gonorrhoeae Gen-Probe, Inc. K063664, K062440
Tigris DTS Gen-Probe Aptima Assay for Neisseria Gonorrhoeae Gen-Probe, Inc. K061509
COBAS Amplicor CT/NG test for Neisseria gonorrhoeae Roche Molecular Systems, Inc. K053289, K974342
Hybrid Capture II CT/GC DNA Test Digene Corp. K981567
Roche AMPLICOR CT/NG test for Neisseria gonorrhoeae Roche Molecular Systems, Inc. K974503
Digene GC-ID Test Hybrid Capture II Digene Corp. K981485
Gen-Probe PACE 2C System Chlamydia Trachomatis / Neisseria gonorrhoeae Gen-Probe, Inc. K940979
PACE2 Neisseria gonorrhoeae probe confirmation assay Gen-Probe, Inc. K920301
GONOSTAT Gonococcal Detection Kit Sierra Diagnostics, Inc. K991268
LCX Neisseria gonorrhoeae Assay Abbott Laboratories K935833
Cytomegalovirus COBAS AmpliPrep/COBAS TaqMan CMV Test Roche Molecular Systems P110037
S001-S002
NucliSens CMV pp67 Organon Teknika Corporation K983762
Dengue virus CDC DENV-1-4 Real-Time RT-PCR Assay Centers for Disease Control and Prevention K113336
Entercoccus IMDx Van R for Abbott m2000 Intelligent Medical Devices, Inc. K123753
BD GeneOhm VanR Assay BD Diagnostics (GeneOhm Sciences, Inc.) K102416
Xpert vanA Assay Cepheid K092953
E. faecalis/OE PNA AdvanDx, Inc. K083074
GBS PNA FISH AdvanDx, Inc. K082612
E. faecalis PNA FISH culture identification kit AdvanDx, Inc. K063127
Enterovirus NucliSens EasyQ Enterovirus vl.1 Assay bioMérieux, Inc. K093383, K063261
Escherichia coli /
Klebsiella pneumoniae /
Pseudomonas aeroginosa
GNR Traffic Light PNA FISH AdvanDx, Inc. K101558
E. coli/P. aeruginosa PNA FISH AdvanDx, Inc. K092236, K081309
EK/P aeruginosa PNA FISH AdvanDx, Inc. K092393, K081433
E. coli PNA FISH AdvanDx, Inc. K082068
Francisella tularensis JBAIDS Tularemia Detection Kit Idaho Technology, Inc. K072547
Gram-Positive /
Gram-Negative Bacteria
Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Nanosphere, Inc. K122514 , K113450
Herpes Simplex Virus IsoAmp HSV Assay BioHelix Corporation K111951
MultiCode-RTx Herpes Simplex Virus 1 & 2 Kit EraGen Biosciences, Inc. K111527 , K100336
BD ProbeTec Herpes Simplex Viruses (HSV I & 2) QX Amplified DNA Assays BD Diagnostic Systems K103798
Hepatitis virus Abbott RealTime HCV Genotype II Abbott Molecular, Inc. P120012
Abbott Realtime HCV Assay Abbott Molecular, Inc. P100017 S001-S006
Abbott Realtime HBV Assay Abbott Molecular, Inc. P080026 S001-S004
COBAS AmpliPrep/COBAS TaqMan HCV test Roche Molecular Systems P060030 S001-S032
COBAS Taqman HBV Test Roche Molecular Systems, Inc. P050028 S001-S027
Versant HCV 3.0 Assay (bDNA) Siemens Healthcare Diagnostics P020022
Versant HCV RNA Qualitative Assay Gen-Probe, Inc. P020011 S001-S007
COBAS AMPLICOR Hepatitis C Virus (HCV) Test Roche Molecular Systems, Inc. P000012 S001-S043
AMPLICOR HCV Test, v2.0 Roche Molecular Systems, Inc. P000010 S001-S024
Human Metapneumovirus Quidel Molecular RSV + hMPV Assay Quidel Corporation K131813, K122189
Quidel Molecular hMPV Assay Quidel Corporation K112490
Pro hMPV+ Assay Prodesse, Inc. K132200, K082688
Human papillomavirus Aptima HPV Assay Gen-Probe, Inc. P100042
COBAS HPV Test Roche Molecular Systems, Inc. P100020 S001-S005
Aptima HPV 16 18/45 Genptype Assay Gen-Probe, Inc. P120007
Cervista HPV 16/18 Hologic, Inc. P080015 S001-S016
Cervista HPV HR and Genfind DNA Extraction Kit Hologic, Inc. P080014 S001-S013
Digene Hybrid Capture 2 High-Risk HPV DNA Test Digene Corporation P890064 S001-S027
Influenza and Respiratory Viruses Prodesse ProFAST Assat Gen-Probe Prodesse, Inc. K132237
Quidel Molecular Influenza A + B Assay Quidel Corporation K131728, K113777, K112172
IMDx Flu A/B and RSV for Abbott m2000 Intelligent Medical Devices, Inc. K131584
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel Centers for Disease Control and Prevention K133869, K132508, K130551, K123905, K111507
Prodesse ProParaflu Assay Gen-Probe Prodesse, Inc. K132238, K091053
Xpert Flu Assay Cepheid K123191, K120911, K103766
Simplexa Flu A/B & RSV Direct Focus Diagnostics, Inc. K120413
FilmArray Respiratory Panel (RP) Idaho Technology, Inc. K123620, K120267, K110764, K103175
artus Infl A/B RG RT-PCR Kit Qiagen GmbH K113323
xTAG Respiratory Viral Panel (RVP) Luminex Molecular Diagnostics, Inc. K112781, K112199, K091667, K081483, K063765
JBAIDS Influenza A Subtyping Kit U.S. Army Medical Materiel Development Activity K111778
JBAIDS Influenza A&B Detection Kit U.S. Army Medical Materiel Development Activity K111775
eSensor Respiratory Viral Panel (RVP) GenMark Diagnostic K113731
Liat Influenza A/B Assay IQuum, Inc. K111387
ProFlu+ Assay Gen-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 & RSV Focus Diagnostics, Inc. K102170
CDC Influenza 2009 A (H1N1) pdm Real-Time RT-PCR Panel Centers for Disease Control and Prevention K101564
JBAIDS Influenza A/H5 (Asian lineage) Detection Kit U.S. Army Medical Materiel Development Activity K100287
Simplexa Influenza A H1N1 (2009) Focus Diagnostics, Inc . K100148
CDC Human Influenza Virus Real-time RT-PCR Detection and Characterization Panel Centers for Disease Control and Prevention K080570
Influenza A/H5 (Asian lineage) Virus Real-time RT-PCR Primer and Probe Set Centers for Disease Control and Prevention K060159
Leishmania species SMART Leish U.S. Army Medical Materiel Development Activity K081868
Mycobacterium tuberculosis Xpert MTB/RIF Assay Cepheid K131706
BDProbetec ET Mycobacterium tuberculosis complex culture identification kit Becton, Dickinson, & Co. K000884
Amplified Mycobacterium tuberculosis Direct Test Gen-Probe, Inc. P940034
Amplicor Mycobacterium tuberculosis test Roche Molecular Systems, Inc. P940040
SNAP M.tuberculosis complex Syngene, Inc. K900292
Accuprobe Mycobacterium tuberculosis complex Test Gen-Probe, Inc. K896493
Rapid Diagnostic System for Mycobacterium tuberculosis Gen-Probe, Inc. K871795
Rapid Identification Test for Mycobacterium tuberculosis complex Gen-Probe, Inc. K862614
Mycobacterium species Accuprobe Mycobacterium avium complex culture Gen-Probe, Inc. K921435, K896494, K897078
Accuprobe Mycobacterium kansasii Identification Test Gen-Probe, Inc. K904463
SNAP Mycobacterium avium complex Syngene, Inc. K900202
Accuprobe Mycobacterium intracellulare Culture Identification Test Gen-Probe, Inc. K897077
Accuprobe Mycobacterium gordonae culture identification Test Gen-Probe, Inc. K896492
Rapid Diagnostic System for Mycobacterium gordonae Gen-Probe, Inc. K890089
Rapid Diagnostic System for Mycobacteria Gen-Probe, Inc. K864597
Rapid Identification Test for Mycobacterium avium Gen-Probe, Inc. K862613
Gen-Probe Mycobacterium Rapid Confirmation System Gen-Probe, Inc. K860782
Mycoplasma pneumoniae Illumigene Mycoplasma DNA Amplification Assay Meridian Bioscience, Inc. K123423
Multiplex Panel ProGastro SSCS Assay Gen-Probe Prodesse, Inc. K123274
xTAG Gastrointestinal Pathogen Panel (GPP) Luminex Molecular Diagnostics, Inc. K121894, K121454
Staphylococcus BD Max MRSA Assay BD Diagnostics (GeneOhm Sciences Canada, Inc.) K120138
Staphylococcus QuickFISH BC AdvanDx, Inc. K113371
MRSA/SA ELITe MGB EliTechGroup Epoch Biosciences. K112937
Verigene Staphylococcus Blood Culture (BC-S) Nucleic Acid Test Nanosphere, Inc. K112424
NucliSENS EasyQ MRSA Assay bioMerieux, Inc. K102740
Xpert MRSA/SA Blood Culture Assay Cepheid K101879, K082140
Xpert MRSA/SA Nasal Complete Assay Cepheid K100822
LightCycler MRSA Advanced Test Roche Molecular Systems, Inc K091409
BD GeneOhm MRSA ACP Assay BD Diagnostics (GeneOhm Sciences Canada, Inc.) K093346
S. aureus and/or other Staphylococcus species PNA FISH Culture AdvanDx, Inc. K092166
Xpert MRSA/SA SSTI Assay Cepheid K080837
BD GeneOhM StaphSR Assay BD Diagnostics (GeneOhm Sciences Canada, Inc.) K071026
S. aureus PNA FISH AdvanDx, Inc. K091827, K060099
Xpert MRSA Cepheid K070462
IDI-MRSA Assay Infectio Diagnostic, Inc. K042357, K033415
Streptococci Xpert GBS LB Assay Cepheid K121539
illumigene Group A Streptococcus (GBS) DNA Amplification Assay Meridian Bioscience, Inc. K122019
illumigene Group B Streptococcus (GBS) DNA Amplification Assay Meridian Bioscience, Inc. K121044
BD Max GBS Assay Becton, Dickinson, & Co. K111860
Cepheid Smart GBS Assay Cepheid K062948
Xpert GBS Cepheid K060540
IDI-Strep B Assay Infectio Diagnostic, Inc. K022504
Gen-Probe Accuprobe Group B Streptococcus culture identification kit Chugai Pharmaceuticals Co, Ltd. K974572
Accuprobe Streptococcus pneumoniae culture confirmation Gen-Probe, Inc. K902908
Trichomonas vaginalis Aptima Trichomonas vaginalis assay Gen-Probe, Inc. K102911
Affirm/VP Identification Test G. Vaginalis and T. vaginalis Microprobe Corp. K923133
Yersinia pestis JBAIDS Plague Detection Kit Idaho Technology, Inc. K072631

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Page Last Updated: 01/27/2015
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