Devices descending from K091667
89 later devices reach Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112… through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +1 | K123838 | Pro HMPV+ Assay | Gen-Probe Prodesse, Inc. | 2013 | 1 | — |
| +1 | K112781 | Tag Respiratory Viral Panel Tag Data Analysis Software (Tdas RVP-I) | Luminex Molecular Diagnostics, Inc. | 2012 | 0 | 1 |
| +1 | K103776 | Xtag Respiratory Viral Panel Fast, Xtag Data Analysis Software for RVP Fast | Luminex Molecular Diagnostics, Inc. | 2011 | 0 | — |
| +1 | K110764 | Filmarray RP Panel | Idaho Technology, Inc. | 2011 | 22 | — |
| +1 | K103175 | Filmarray Respiratory Panel (RP) | Idaho Technology, Inc. | 2011 | 23 | — |
| +1 | K102952 | Prodesse Proadeno | Gen-Probe Prodesse, Inc. | 2010 | 3 | — |
| +1 | K101855 | Profast+ Assay | Gen-Probe Prodesse, Inc. | 2010 | 5 | — |
| +1 | K100148 | Simplexa Influenza a H1N1 (2009) Model MOL2500 | Focus Diagnostics, Inc. | 2010 | 34 | — |
| +1 | K092500 | Modification to Proflu+ Assay | Prodesse, Inc. | 2009 | 41 | — |
| +2 | K153544 | cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System | Iquum, Inc. | 2016 | 4 | — |
| +2 | K143653 | Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) | Nanosphere, Inc. | 2015 | 1 | 5 |
| +2 | K143178 | FilmArray 2.0 System | Biofire Diagnostics, LLC | 2015 | 0 | 1 |
| +2 | K133673 | Illumigene Pertusis Dna Amplification Assay, Illumigene Pertussis External Control Kit… | Meridian Bioscience, Inc. | 2014 | 5 | — |
| +2 | K131813 | Quidel Molecular RSV + HMPV Assay | Quidel Corp. | 2013 | 7 | — |
| +2 | K131728 | Quidel Molecular Influenza a + B Assay | Quidel Corp. | 2013 | 2 | — |
| +2 | K132237 | Prodesse Profast+ Assay | Gen-Probe Prodesse, Inc. | 2013 | 0 | — |
| +2 | K132159 | Proadeno+ Assay | Gen-Probe Prodesse, Inc. | 2013 | 0 | — |
| +2 | K132200 | Pro HMPV+ Assay | Gen-Probe Prodesse, Inc. | 2013 | 0 | — |
| +2 | K122189 | Quidel Molecular RSV + HMPV Assay | Quidel Corp. | 2013 | 0 | — |
| +2 | K123620 | Filmarray Respiratory Panel (RP) | Biofire Diagnostics, Inc. | 2013 | 18 | — |
| +2 | K121942 | Adenovirus R-Gene US | Argene SA | 2013 | 1 | — |
| +2 | K121003 | Abbott Plex-ID Flu Assay | Abbott Laboratories | 2012 | 0 | — |
| +2 | K120413 | Simplexa Flu a/B & RSV Direct, Simplexa Flu a/B & RSV Positive Control Pack | Focus Diagnostics, Inc. | 2012 | 3 | 2 |
| +2 | K120267 | Filmarray RP Panel | Idaho Technology, Inc. | 2012 | 21 | — |
| +2 | K113777 | Quidel Molecular Influenza a+B | Quidel Corp. | 2012 | 3 | — |
| +2 | K112172 | Quidel Molecular Influenza a + B Assay | Quidel Corp. | 2011 | 3 | — |
| +2 | K110968 | Proflu+ Assay | Gen-Probe Prodesse, Inc. | 2011 | 15 | — |
| +2 | K103766 | Xpert Flu, Genexpert DX Systems, Genexpert Infinity System, Genexpert System Software… | Cepheid | 2011 | 27 | 1 |
| +2 | K103209 | Verigene Respiratory Virus Nucleic Acid Test +(Rvnat+) | Nanosphere, Inc. | 2011 | 2 | 1 |
| +2 | K102170 | Simplexa Flu a/B & RSV | Focus Diagnostics, Inc. | 2010 | 0 | — |
| +3 | K243753 | cobas liat Bordetella panel nucleic acid test | Roche Molecular Systems, Inc. | 2025 | 0 | — |
| +3 | K230349 | Lyra RSV+hMPV Assay | Quidel Corporation | 2023 | 0 | — |
| +3 | K230236 | Lyra Influenza A+B Assay | Quidel Corporation | 2023 | 0 | — |
| +3 | K200065 | cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza… | Roche Molecular Systems, Inc. | 2020 | 3 | — |
| +3 | K183597 | QIAstat-Dx Respiratory Panel | QIAGEN GmbH | 2019 | 0 | — |
| +3 | K171974 | Solana RSV+hMPV Assay | Quidel Corporation | 2017 | 0 | — |
| +3 | K163628 | Idylla Respiratory (IFV-RSV) Panel | Janssen Pharmaceutica NV | 2017 | 0 | — |
| +3 | K163626 | ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit | Luminex Corporation | 2017 | 2 | 1 |
| +3 | K170284 | Great Basin Bordetella Direct Test | Great Basin Scientific, Inc. | 2017 | 0 | — |
| +3 | K161814 | Solana Influenza A+B Assay | Quidel Corporation | 2016 | 0 | — |
| +3 | K161375 | Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit | Alere Scarborough, Inc. | 2016 | 4 | 2 |
| +3 | K161220 | ARIES® Flu A/B & RSV Assay | Luminex Corporation | 2016 | 0 | 1 |
| +3 | K143080 | FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray System | Biofire Diagnostics, LLC | 2015 | 10 | — |
| +3 | K143206 | AmpliVue Bordetella Assay | Quidel Corporation | 2014 | 0 | — |
| +3 | K142365 | Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack | Focus Diagnostics | 2014 | 1 | — |
| +3 | K142045 | Xpert Flu/RSV XC Assay | Cepheid | 2014 | 5 | — |
| +3 | K141931 | Lyra Adenovirus Assay | Quidel Corporation | 2014 | 0 | — |
| +3 | K131584 | Imdx Flu a/B and RSV for Abbott M2000 | Intelligent Medical Devices, Inc. | 2013 | 0 | — |
| +3 | K132129 | Prodesse Proflu+ Assay | Gen-Probe Prodesse, Inc. | 2013 | 13 | — |
| +3 | K123423 | Illumigene Mycoplasama Dna Amplification Assay, and Illumigene Mycoplasma External… | Meridian Bioscience, Inc. | 2013 | 1 | — |
| +3 | K120911 | Xpert Flu Genexpert DX Systems (GX-I, GX-IV) | Cepheid | 2012 | 7 | — |
| +3 | K113323 | Artus Infl a/B RG RT-PCR Kit | QIAGEN GmbH | 2012 | 0 | — |
| +3 | K111387 | Liat (TM) Influenza a / B Assay, Liat (TM) Analyzer | Iquum, Inc. | 2011 | 18 | 4 |
| +4 | K260047 | cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas… | Roche Molecular Systems, Inc. | 2026 | 0 | — |
| +4 | K210234 | cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System | Roche Molecular Systems, Inc. | 2021 | 1 | — |
| +4 | K191729 | Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System | Roche Molecular Systems, Inc. | 2019 | 4 | — |
| +4 | K173498 | Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack | Diasorin Molecular, LLC | 2018 | 1 | — |
| +4 | K173932 | Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 | Alere Scarborough, Inc. | 2018 | 3 | — |
| +4 | K162456 | Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems… | Cepheid | 2017 | 2 | — |
| +4 | K162331 | Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems… | Cepheid | 2017 | 0 | — |
| +4 | K152579 | FilmArray Respiratory Panel EZ (RP EZ) | Biofire Diagnostics, LLC | 2016 | 0 | — |
| +4 | K160829 | illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct… | Meridian Bioscience, Inc. | 2016 | 0 | — |
| +4 | K160068 | FilmArray Respiratory Panel (RP) for use with FilmArray Torch | Biofire Diagnostics, LLC | 2016 | 6 | 1 |
| +4 | K151226 | Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress… | Cepheid | 2015 | 4 | — |
| +4 | K153219 | ProFlu+ Assay | Hologic, Inc. | 2015 | 1 | — |
| +4 | K152408 | Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack | Focus Diagnostics, Inc. | 2015 | 0 | 1 |
| +4 | K141520 | Alere I Influenza a & B | Alere Scarborough, Inc D/B/A Binax, Inc. | 2014 | 11 | 3 |
| +4 | K123191 | Xpert Flu | Cepheid | 2012 | 6 | — |
| +5 | K262747 | ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0 | Abbott Diagnostics Scarborough, Inc. | 2026 | 0 | — |
| +5 | K213822 | cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System | Roche Molecular Systems, Inc. | 2022 | 0 | — |
| +5 | K190204 | ID NOW Influenza A & B 2 | Alere Scarborough, Inc. | 2019 | 1 | — |
| +5 | K183223 | Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack | Diasorin Molecular, LLC | 2018 | 0 | — |
| +5 | K180218 | Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample… | Cepheid | 2018 | 0 | — |
| +5 | K171641 | Accula Flu A/Flu B Test | Mesa Biotech, Inc. | 2018 | 0 | — |
| +5 | K171552 | Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample… | Cepheid | 2017 | 1 | — |
| +5 | K171963 | Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion… | Hologic, Inc. | 2017 | 0 | 1 |
| +5 | K163636 | ePlex Respiratory Pathogen Panel | Genmark Diagnostics, Incorporated | 2017 | 0 | — |
| +5 | K170604 | FilmArray Respiratory Panel 2 (RP2) | Biofire Diagnostics, LLC | 2017 | 4 | — |
| +5 | K151464 | Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab Kit | Alere Scarborough, Inc. | 2015 | 8 | — |
| +5 | K151690 | Alere i Instrument, Alere i Influenza A & B, Alere i Strep A | Alere Scarborough, Inc. | 2015 | 4 | — |
| +6 | K192485 | BioCode Respiratory Pathogen Panel (RPP) | Applied BioCode, Inc. | 2019 | 1 | — |
| +6 | K191534 | ID NOW Influenza A & B 2 | Abbott Diagnostics Scarborough, Inc. | 2019 | 0 | — |
| +6 | K172629 | Panther Fusion AdV/hMPV/RV Assay | Hologic, Inc. | 2017 | 1 | — |
| +6 | K163266 | Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument | Alere Scarborough, Inc. | 2016 | 7 | — |
| +7 | K254139 | BioCode® Respiratory Pathogen Panel (RPP) | Applied BioCode, Inc. | 2026 | 0 | — |
| +7 | K231017 | Panther Fusion AdV/hMPV/RV Assay | Hologic, Inc. | 2023 | 0 | — |
| +7 | K171792 | Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit | Alere Scarborough, Inc. | 2017 | 6 | 1 |
| +8 | K220801 | ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 | Abbott Diagnostics Scarborough, Inc. | 2022 | 2 | — |
| +9 | K232775 | ID NOW Influenza A & B 2 | Abbott Diagnostics Scarborough, Inc. | 2023 | 1 | 2 |