List of 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 [1].
- Human Genetic Tests [2]
- Microbial Tests [3]
List of Human Genetic Tests
| Disease | Trade Name | Manufacturer | Submission | |
|---|---|---|---|---|
| Acute Myeloid Leukemia | Vysis EGR1 FISH Probe Kit | Abbott Molecular Inc. | K091960 [4] | |
| B-cell chronic lymphocytic leukemia | Vysis CLL FISH Probe Kit | Vysis | K100015 [5] | |
| CEP 12 SpectrumOrange Direct Labeled Chromosome Enumeration DNA Probe | Vysis | K962873 [6] | ||
| Bladder Cancer | Vysis UroVysion Bladder Cancer Recurrence Kit | Vysis | K033982 [7], K013785 [8], K011031 [9] | |
| Breast Cancer | MammaPrint | Agendia BV | K101454 [10], K081092 [11], K080252 [12], K070675 [13], K062694 [14] | |
| GeneSearch Breast Lymph Node (BLN) Test Kit | Veridex, LLC. | P060017 [15] S001-S004 | ||
| Dako TOP2A FISH PharmDx Kit | Dako Denmark A/S | P050045 [16] S001-S004 | ||
| Cystic Fibrosis | eSensor® CF Genotyping Test | Osmetech Molecular Diagnostics | K090901 [17] | |
| xTAG Cystic Fibrosis 60 Kit v2 | Luminex Molecular Diagnostics Inc. | K083845 [18] | ||
| xTAG Cystic Fibrosis 39 Kit v2 | Luminex Molecular Diagnostics Inc. | K083846 [19] | ||
| Verigene® CFTR and Verigene® CFTR PolyT Nucleic Acid Tests | Nanosphere, Inc | K083294 [20] | ||
| InPlex CF Molecular Test | Third Wave Technology, Inc. | K063787 [21] | ||
| Cystic Fibrosis Genotyping Assay | Celera Diagnostics | K062028 [22] | ||
| Tag-It Cystic Fibrosis Kit | Tm Bioscience Corporation | K060627 [23], K043011 [24] | ||
| eSensor Cystic Fibrosis Carrier Detection System | Clinical Micro Sensors, Inc. | K060543 [25], K051435 [26] | ||
| Drug metabolizing enzymes | INFINITI CYP2C19 Assay | AutoGenomics, Inc. | K101683 [27] | |
| xTAG® CYP2D6 Kit | Luminex Molecular Diagnostics, Inc. | K093420 [28] | ||
| Invader® UGT1A1 Molecular Assay | Third Wave Technologies Inc. | K051824 [29] | ||
| Roche AmpliChip CYP450 microarray | Roche Molecular Systems, Inc. | K043576 [30], K042259 [31] | ||
| eSensor Warfarin Sensitivity Saliva Test | GenMark Diagnostics | K110786 [32] | ||
| eQ-PCR LC Warfarin Genotyping kit | TrimGen Corporation | K073071 [33] | ||
| eSensor Warfarin Sensitivity Test and XT-8 Instrument | Osmetech Molecular Diagnostics | K073720 [34] | ||
| Gentris Rapid Genotyping Assay - CYP2C9 & VKORCI | ParagonDx, LLC | K071867 [35] | ||
| INFINITI 2C9 & VKORC1 Multiplex Assay for Warfarin | AutoGenomics, Inc. | K073014 [36] | ||
| Verigene Warfarin Metabolism Nucleic Acid Test and Verigene System | Nanosphere, Inc. | K070804 [37] | ||
| Coagulation Factors | Invader Factor V | Hologic, Inc. | K100980 [38] | |
| Invader Factor II | Hologic, Inc. | K100943 [39] | ||
| Illumina VeraCode Genotyping Test for Factor V and Factor II | Illumina, Inc. | K093129 [40] | ||
| 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 [41] | ||
| Xpert HemosIL FII & FV | Cepheid | K082118 [42] | ||
| Verigene F5 Nucleic Acid Test Verigene F2 Nucleic Acid Test Verigene MTHFR Nucleic Acid Test |
Nanosphere, Inc. | K070597 [43] | ||
| INFINITI System | Autogenomics, Inc. | K060564 [44] | ||
| Factor II (Prothrombin) G20210A Kit | Roche Diagnostics Corporation | K033612 [45] | ||
| Factor V leiden Kit | Roche Diagnostics Corporation | K033607 [46] | ||
| Invader MTHFR 677 | Hologic, Inc. | K100987 [47] | ||
| Invader MTHFR 1298 | Hologic, Inc. | K100496 [48] | ||
| Heart Transplant | AlloMap Molecular Expression Testing | xDx | K073482 [49] | |
| Chromosome abnormalities | AneuVysion | Vysis | K010288 [50], K972200 [51] | |
| CEP 8 Spectrumorange DNA Probe Kit | Vysis | K953591 [52] | ||
| CEP X SpectrumOrange/ Y SpectrumGreen DNA Probe Kit | Vysis | K954214 [53] | ||
| Prostate Cancer | NADiA ProsVue | Iris Molecular Diagnostics | K101185 [54] | |
| PROGENSA PCA3 Assay | Gen-Probe, Inc. | P100033 [55] | ||
| Tissue of Origin | Pathwork Tissue of Origin Test Kit – FFPE | Pathwork Diagnostics Inc. | K120489 [56], K092967 [57] | |
| Pathwork Tissue of Origin Test | Pathwork Diagnostics Inc. | K080896 [58] | ||
List of Microbial Tests
| Microorganism | Trade Name | Manufacturer | Submission |
|---|---|---|---|
| Bacillus Anthracis | JBAIDS Anthrax Detection System | Idaho Technology, Inc. | K071188 [59], K051713 [60] |
| Candida tropicalis / Candida albicans / Candida parapsilosis / Candida glabrata / Candida krusei | Affirm VPIII Microbial Identification Test | Microprobe Corp. | K931151 [61], K931374 [62] |
| Yeast Traffic Light PNA FISH | AdvanDx, Inc. | K093024 [63], K080719 [64] | |
| C. albicans / C. glabrata PNA FISH | AdvanDx, Inc. | K092784 [65] | |
| C. albicans PNA FISH | AdvanDx, Inc. | K092655 [66], K062461 [67] | |
| C. Albicans screen | Carr-Scarborough Microbiologicals, Inc. | K891476 [68] | |
| Clostridium difficile | Portrait Toxigenic C. difficile Assay | Great Basin Scientific, Inc. | K113358 [69] |
| Simplexa C. difficile Universal Direct Assay | Focus Diagnostics, Inc. | K113433 [70] | |
| Xpert C. difficile/Epi | Cepheid | K110203 [71] | |
| Illumigene C. difficile DNA Amplification Assay | Meridian Bioscience, Inc. | K110012 [72] | |
| Illumigene C. difficile Assay | Meridian Bioscience, Inc. | K100818 [73] | |
| Xpert C. difficile | Cepheid | K091109 [74] | |
| ProGastro Cd Assay | Prodesse Inc. | K090239 [75] | |
| BD GeneOhm C. diff Assay | BD Diagnostics/ GeneOhm Sciences, Inc. | K081920 [76] | |
| Coxiella burnetii | Joint Biological Agent Identification and Diagnostic System (JBAIDS) Q Fever Detection Kit | Idaho Technology, Inc. | K103207 [77] |
| Chlamydia trachomatis / Neisseria gonorrhoeae | Aptima Combo 2 Assay (Panther System) | Gen-Probe, Inc. | K111409 [78] |
| Cobas CT/NG Test | Roche Molecular Systems, Inc. | K110923 [79] | |
| Abbott RealTime CT/NG and Multi-Collect Specimen Collection Kit | Abbott Molecular Inc. | K092704 [80], K080739 [81] | |
| BD ProbeTec Chlamydia trachomatis (CT) Qx Amplified DNA Assay | Becton, Dickinson, & Co. | K091724 [82], K090824 [83], K081824 [84] | |
| AMPLICOR CT/NG Test for Chlamydia trachomatis | Roche Diagnostics Corp. | K070174 [85], K973707 [86] | |
| Gen-Probe Aptima for Chlamydia Trochamatis | Gen-Probe, Inc. | K063451 [87], K053446 [88], K043072 [89] | |
| TIGRIS DTS Automated Analyzer Aptima Assay for Chlamydia trachomatis | Gen-Probe, Inc. | K061413 [90] | |
| TIGRIS DTS Gen-Probe Aptima Combo 2 Assay | Gen-Probe, Inc. | K060652 [91] | |
| Cobas Amplicor CT/NG test for Chlamydia trachomatis | Roche Molecular Systems, Inc. | K053287 [92], K973718 [93] | |
| GEN-PROBE Aptima Combo 2 Assay | Gen-Probe, Inc. | K043224 [94], K032554 [95], | |
| BDProbeTec ET Chlamydia trachomatis and Neisseria gonorrhoeae Amplified DNA Assays | Becton, Dickinson, & Co. | K012351 [96], K003395 [97], K984631 [98] | |
| Roche Cobas AMPLICOR Chlamydia trachomatis test | Roche Molecular Systems, Inc. | K964507 [99] | |
| Gen-Probe AMPLIFIED Chlamydia trachomatis Assay Kit | Gen-Probe, Inc. | K962217 [100] | |
| LCX Chlamydia trachomatis Assay | Abbott Laboratories | K934622 [101] | |
| BD Probetec Neisseria Gonorrhoeae (GC) Qx Amplified DNA Assay | Becton, Dickinson, & Co. | K091730 [102], K090971 [103], K090827 [104], K081825 [105] | |
| AMPLICOR CT/NG Test for Neisseria Gonorrhoeae | Roche Diagnostics Corp. | K070172 [106] | |
| Gen-Probe Aptima Assay for Neisseria Gonorrhoeae | Gen-Probe, Inc. | K063664 [107], K062440 [108] | |
| Tigris DTS Gen-Probe Aptima Assay for Neisseria Gonorrhoeae | Gen-Probe, Inc. | K061509 [109] | |
| COBAS Amplicor CT/NG test for Neisseria gonorrhoeae | Roche Molecular Systems, Inc. | K053289 [110], K974342 [111] | |
| Hybrid Capture II CT/GC DNA Test | Digene Corp. | K981567 [112] | |
| Roche AMPLICOR CT/NG test for Neisseria gonorrhoeae | Roche Molecular Systems, Inc. | K974503 [113] | |
| Digene GC-ID Test Hybrid Capture II | Digene Corp. | K981485 [114] | |
| Gen-Probe PACE 2C System Chlamydia Trachomatis / Neisseria gonorrhoeae | Gen-Probe, Inc. | K940979 [115] | |
| PACE2 Neisseria gonorrhoeae probe confirmation assay | Gen-Probe, Inc. | K920301 [116] | |
| GONOSTAT Gonococcal Detection Kit | Sierra Diagnostics, Inc. | K991268 [117] | |
| LCX Neisseria gonorrhoeae Assay | Abbott Laboratories | K935833 [118] | |
| Entercoccus faecalis | E. faecalis/OE PNA | AdvanDx, Inc. | K083074 [119] |
| GBS PNA FISH | AdvanDx, Inc. | K082612 [120] | |
| E. faecalis PNA FISH culture identification kit | AdvanDx, Inc. | K063127 [121] | |
| Escherichia coli / Klebsiella pneumoniae / Pseudomonas aeroginosa | GNR Traffic Light PNA FISH | AdvanDx, Inc. | K101558 [122] |
| E. coli/P. aeruginosa PNA FISH | AdvanDx, Inc. | K092236 [123], K081309 [124] | |
| EK/P aeruginosa PNA FISH | AdvanDx, Inc. | K092393 [125], K081433 [126] | |
| E. coli PNA FISH | AdvanDx, Inc. | K082068 [127] | |
| Francisella tularensis | JBAIDS Tularemia Detection Kit | Idaho Technology, Inc. | K072547 [128] |
| Leishmania species | SMART Leish | U.S. Army Medical Materiel Development Activity | K081868 [129] |
| Mycobacterium tuberculosis | BDProbetec ET Mycobacterium tuberculosis complex culture identification kit | Becton, Dickinson, & Co. | K000884 [130] |
| Amplified Mycobacterium tuberculosis Direct Test | Gen-Probe, Inc. | P940034 [131] | |
| Amplicor Mycobacterium tuberculosis test | Roche Molecular Systems, Inc. | P940040 [132] | |
| SNAP M.tuberculosis complex | Syngene, Inc. | K900292 [133] | |
| Accuprobe Mycobacterium tuberculosis complex Test | Gen-Probe, Inc. | K896493 [134] | |
| Rapid Diagnostic System for Mycobacterium tuberculosis | Gen-Probe, Inc. | K871795 [135] | |
| Rapid Identification Test for Mycobacterium tuberculosis complex | Gen-Probe, Inc. | K862614 [136] | |
| Mycobacterium species | Accuprobe Mycobacterium avium complex culture | Gen-Probe, Inc. | K921435 [137], K896494 [138], K897078 [139] |
| Accuprobe Mycobacterium kansasii Identification Test | Gen-Probe, Inc. | K904463 [140] | |
| SNAP Mycobacterium avium complex | Syngene, Inc. | K900202 [141] | |
| Accuprobe Mycobacterium intracellulare Culture Identification Test | Gen-Probe, Inc. | K897077 [142] | |
| Accuprobe Mycobacterium gordonae culture identification Test | Gen-Probe, Inc. | K896492 [143] | |
| Rapid Diagnostic System for Mycobacterium gordonae | Gen-Probe, Inc. | K890089 [144] | |
| Rapid Diagnostic System for Mycobacteria | Gen-Probe, Inc. | K864597 [145] | |
| Rapid Identification Test for Mycobacterium avium | Gen-Probe, Inc. | K862613 [146] | |
| Gen-Probe Mycobacterium Rapid Confirmation System | Gen-Probe, Inc. | K860782 [147] | |
| Staphylococcus aureus | BD Max MRSA Assay | BD Diagnostics (GeneOhm Sciences Canada, Inc.) | K120138 [148] |
| Staphylococcus QuickFISH BC | AdvanDx, Inc. | K113371 [149] | |
| MRSA/SA ELITe MGB | EliTechGroup Epoch Biosciences. | K112937 [150] | |
| Verigene Staphylococcus Blood Culture (BC-S) Nucleic Acid Test | Nanosphere, Inc. | K112424 [151] | |
| NucliSENS EasyQ MRSA Assay | bioMerieux, Inc. | K102740 [152] | |
| Xpert MRSA/SA Blood Culture Assay | Cepheid | K101879 [153], K082140 [154] | |
| Xpert MRSA/SA Nasal Complete Assay | Cepheid | K100822 [155] | |
| LightCycler MRSA Advanced Test | Roche Molecular Systems, Inc | K091409 [156] | |
| BD GeneOhm MRSA ACP Assay | BD Diagnostics (GeneOhm Sciences Canada, Inc.) | K093346 [157] | |
| S. aureus and/or other Staphylococcus species PNA FISH Culture | AdvanDx, Inc. | K092166 [158] | |
| Xpert MRSA/SA SSTI Assay | Cepheid | K080837 [159] | |
| BD GeneOhM StaphSR Assay | BD Diagnostics (GeneOhm Sciences Canada, Inc.) | K071026 [160] | |
| S. aureus PNA FISH | AdvanDx, Inc. | K091827 [161], K060099 [162] | |
| Xpert MRSA | Cepheid | K070462 [163] | |
| IDI-MRSA Assay | Infectio Diagnostic, Inc. | K042357 [164], K033415 [165] | |
| Streptococci | Xpert GBS LB Assay | Cepheid | K121539 [166] |
| illumigene Group A Streptococcus (GBS) DNA Amplification Assay | Meridian Bioscience, Inc. | K122019 [167] | |
| illumigene Group B Streptococcus (GBS) DNA Amplification Assay | Meridian Bioscience, Inc. | K121044 [168] | |
| BD Max GBS Assay | Becton, Dickinson, & Co. | K111860 [169] | |
| Cepheid Smart GBS Assay | Cepheid | K062948 [170] | |
| Xpert GBS | Cepheid | K060540 [171] | |
| IDI-Strep B Assay | Infectio Diagnostic, Inc. | K022504 [172] | |
| Gen-Probe Accuprobe Group B Streptococcus culture identification kit | Chugai Pharmaceuticals Co, Ltd. | K974572 [173] | |
| Accuprobe Streptococcus pneumoniae culture confirmation | Gen-Probe, Inc. | K902908 [174] | |
| Trichomonas vaginalis | Aptima Trichomonas vaginalis assay | Gen-Probe, Inc. | K102911 [175] |
| Affirm/VP Identification Test G. Vaginalis and T. vaginalis | Microprobe Corp. | K923133 [176] | |
| Yersinia pestis | JBAIDS Plague Detection Kit | Idaho Technology, Inc. | K072631 [177] |