FDA 510(k) Applications for Medical Device Product Code "OCC"
(Respiratory Virus Panel Nucleic Acid Assay System)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K191534 | Abbott Diagnostics Scarborough, Inc. | ID NOW Influenza A & B 2 | 07/11/2019 |
| K121003 | ABBOTT LABORATORIES | ABBOTT PLEX-ID FLU ASSAY | 12/21/2012 |
| K141520 | ALERE SCARBOROUGH, INC D/B/A BINAX, INC. | ALERE I INFLUENZA A & B | 06/13/2014 |
| K171792 | Alere Scarborough, Inc. | Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit | 09/29/2017 |
| K163266 | ALERE SCARBOROUGH, INC. | Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument | 12/21/2016 |
| K151464 | ALERE SCARBOROUGH, INC. | Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab Kit | 07/28/2015 |
| K173932 | Alere Scarborough, Inc. | Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 | 01/26/2018 |
| K161375 | ALERE SCARBOROUGH, INC. | Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit | 08/18/2016 |
| K192485 | Applied BioCode, Inc. | BioCode Respiratory Pathogen Panel (RPP) | 12/23/2019 |
| K121942 | ARGENE SA | ADENOVIRUS R-GENE US | 02/08/2013 |
| K123620 | BIOFIRE DIAGNOSTICS, INC. | FILMARRAY RESPIRATORY PANEL (RP) | 02/11/2013 |
| K160068 | BioFire Diagnostics, LLC | FilmArray Respiratory Panel (RP) for use with FilmArray Torch | 02/08/2016 |
| K143080 | BioFire Diagnostics, LLC | FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray System | 02/17/2015 |
| K170604 | BioFire Diagnostics, LLC | FilmArray Respiratory Panel 2 (RP2) | 05/30/2017 |
| K152579 | BIOFIRE DIAGNOSTICS, LLC | FilmArray Respiratory Panel EZ (RP EZ) | 10/03/2016 |
| K123191 | CEPHEID | XPERT FLU | 12/21/2012 |
| K142045 | CEPHEID | XPERT FLU/RSV XC ASSAY | 11/22/2014 |
| K151226 | CEPHEID | Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I) | 12/03/2015 |
| K162456 | CEPHEID | Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 System | 02/13/2017 |
| K181289 | Cepheid | Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48S System and GeneXpert Infinity-80 System | 08/15/2018 |
| K171552 | Cepheid | Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV | 12/19/2017 |
| K162331 | CEPHEID | Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 System | 02/09/2017 |
| K180218 | Cepheid | Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV | 07/24/2018 |
| K201505 | DiaSorin Molecular LLC | Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack | 08/22/2020 |
| K142365 | FOCUS DIAGNOSTICS | Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack | 12/05/2014 |
| K102170 | FOCUS DIAGNOSTICS, INC. | SIMPLEXA FLU A/B & RSV | 11/24/2010 |
| K152408 | FOCUS DIAGNOSTICS, INC. | Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack | 09/21/2015 |
| K120413 | FOCUS DIAGNOSTICS, INC. | SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK | 07/13/2012 |
| K132159 | GEN-PROBE PRODESSE, INC | PROADENO+ ASSAY | 08/14/2013 |
| K102952 | GEN-PROBE PRODESSE, INC | PRODESSE PROADENO | 12/03/2010 |
| K110968 | GEN-PROBE PRODESSE, INC | PROFLU+ ASSAY | 06/27/2011 |
| K132129 | GEN-PROBE PRODESSE, INC. | PRODESSE PROFLU+ ASSAY | 08/09/2013 |
| K163636 | GENMARK DIAGNOSTICS, INCORPORATED | ePlex Respiratory Pathogen Panel | 06/09/2017 |
| K231017 | Hologic, Inc. | Panther Fusion AdV/hMPV/RV Assay | 05/05/2023 |
| K172629 | Hologic, Inc. | Panther Fusion AdV/hMPV/RV Assay | 12/04/2017 |
| K171963 | Hologic, Inc. | Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusion Specimen Lysis Tubes | 09/26/2017 |
| K153219 | HOLOGIC, INC. | ProFlu+ Assay | 11/20/2015 |
| K103175 | IDAHO TECHNOLOGY, INC. | FILMARRAY RESPIRATORY PANEL (RP) | 02/17/2011 |
| K110764 | IDAHO TECHNOLOGY, INC. | FILMARRAY RP PANEL | 04/27/2011 |
| K120267 | IDAHO TECHNOLOGY, INC. | FILMARRAY RP PANEL | 05/15/2012 |
| K131584 | INTELLIGENT MEDICAL DEVICES, INC | IMDX FLU A/B AND RSV FOR ABBOTT M2000 | 08/21/2013 |
| K111387 | IQUUM INC | LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER | 08/04/2011 |
| K153544 | IQuum, Inc. | cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System | 07/25/2016 |
| K163628 | JANSSEN PHARMACEUTICA NV | Idylla Respiratory (IFV-RSV) Panel | 08/30/2017 |
| K161220 | LUMINEX CORPORATION | ARIES« Flu A/B & RSV Assay | 08/02/2016 |
| DEN070013 | LUMINEX MOLECULAR DIAGNOSTICS, INC. | ID-TAG RESPIRATORY VIRAL PANEL | 01/03/2008 |
| K152386 | LUMINEX MOLECULAR DIAGNOSTICS, INC. | NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software | 12/17/2015 |
| K193167 | Luminex Molecular Diagnostics, Inc. | NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software | 12/11/2019 |
| K112781 | LUMINEX MOLECULAR DIAGNOSTICS, INC. | TAG RESPIRATORY VIRAL PANEL TAG DATA ANALYSIS SOFTWARE (TDAS RVP-I) | 02/17/2012 |
| K081483 | LUMINEX MOLECULAR DIAGNOSTICS, INC. | XTAG RESPIRATORY VIRAL PANEL | 06/25/2008 |
| K103776 | LUMINEX MOLECULAR DIAGNOSTICS, INC. | XTAG RESPIRATORY VIRAL PANEL FAST, XTAG DATA ANALYSIS SOFTWARE FOR RVP FAST | 07/01/2011 |
| K091667 | LUMINEX MOLECULAR DIAGNOSTICS, INC. | XTAG RESPIRATORY VIRAL PANEL, MODELS I019A0110, I019C011, I019D0112, I019E0113, S019-0116 | 06/25/2009 |
| K112199 | LUMINEX MOLECULAR DIAGNOSTICS, INC. | XTAG RESPIRATORY VIRAL PANEL, XTAG DATA ANALYSIS SOFTWARE (TDAS RVP-1) | 09/01/2011 |
| K181443 | Mesa Biotech, Inc. | Accula RSV Test | 11/23/2018 |
| K143653 | NANOSPHERE, INC | Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) | 09/04/2015 |
| K083088 | NANOSPHERE, INC | VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST | 05/01/2009 |
| K093337 | NANOSPHERE, INC | VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM | 11/17/2009 |
| K092566 | NANOSPHERE, INC | VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM (RVNATSP) | 10/09/2009 |
| K092957 | NANOSPHERE, INC | VERIGENE SYSTEM, VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST | 10/21/2009 |
| K103209 | NANOSPHERE, INC. | VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+) | 01/10/2011 |
| K081030 | PRODESSE, INC. | MODIFICATION TO PROFLU+ ASSAY | 05/02/2008 |
| K092500 | PRODESSE, INC. | MODIFICATION TO PROFLU+ ASSAY | 08/20/2009 |
| K073029 | PRODESSE, INC. | PROFLU+ ASSAY | 01/04/2008 |
| K183597 | QIAGEN GmbH | QIAstat-Dx Respiratory Panel | 05/18/2019 |
| K113323 | QIAGEN, GMBH | ARTUS INFL A/B RG RT-PCR KIT | 02/06/2012 |
| K112172 | QUIDEL CORP. | QUIDEL MOLECULAR INFLUENZA A + B ASSAY | 12/22/2011 |
| K131813 | QUIDEL CORP. | QUIDEL MOLECULAR RSV + HMPV ASSAY | 09/06/2013 |
| K141931 | QUIDEL CORPORATION | LYRA ADENOVIRUS ASSAY | 10/09/2014 |
| K161814 | Quidel Corporation | Solana Influenza A+B Assay | 09/27/2016 |
| K171974 | Quidel Corporation | Solana RSV+hMPV Assay | 10/16/2017 |
| K210234 | Roche Molecular Systems, Inc. | cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System | 02/16/2021 |
| K213822 | Roche Molecular Systems, Inc. | cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System | 07/06/2022 |
| K191729 | Roche Molecular Systems, Inc. | Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System | 07/24/2019 |
| K200065 | Roche Molecular Systems, Inc. | cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System, cobas Strep A Nucleic acid test for use on the cobas Liat System | 02/10/2020 |
| K111775 | U.S. ARMY MEDICAL MATERIAL DEVELOPMENT ACITVITY | JBAIDS INFLUENZA A&B DETECTION KIT | 09/13/2011 |
| K152523 | U.S. ARMY MEDICAL MATERIEL DEVELOPMENT ACTIVITY | JBAIDS Influenza A & B Detection Kit | 10/01/2015 |
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