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
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
DEN070013 LUMINEX MOLECULAR DIAGNOSTICS, INC. ID-TAG RESPIRATORY VIRAL PANEL 01/03/2008
K063765 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
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
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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