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
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
K151226 CEPHEID Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I) 12/03/2015
K142045 CEPHEID XPERT FLU/RSV XC ASSAY 11/22/2014
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
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
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
K063765 LUMINEX MOLECULAR DIAGNOSTICS, INC. ID-TAG RESPIRATORY VIRAL PANEL 01/03/2008
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
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
K191729 Roche Molecular Systems, Inc. Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System 07/24/2019
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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