Product Code: OCC
FDA class 2
21 CFR 866.3980
Respiratory Virus Panel Nucleic Acid Assay System
Microbiology
The Respiratory Virus Panel Nucleic Acid Assay System (product code OCC) is a microbiology in vitro diagnostic device designed to simultaneously detect and identify multiple viral nucleic acids from human respiratory specimens or viral culture, including Influenza A and B (with subtypes H1 and H3), RSV subtypes A and B, Parainfluenza 1-3, Human Metapneumovirus, Rhinovirus, and Adenovirus. Detection and identification of these viruses aids in diagnosis of respiratory viral infections when used alongside clinical and laboratory findings. This device is FDA Class 2 under regulation 866.3980 in the Microbiology specialty, requiring 510(k) clearance. It carries no implant or life-sustaining flags.
510(k)s
78
FEI Numbers
29
Registration Numbers
29
Unique Applicants
40
Years Active
17
Basic Information
- Product Code
- OCC
- Device Class
- FDA class 2
- Regulation Number
- 866.3980
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
Definition
A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection when used in conjunction with other clinical and laboratory findings. The device is intended for detection and identification of a combination of the following viruses: Influenza A and Influenza B, Influenza A subtype H1 and Influenza A subtype H3, Respiratory Syncytial Virus subtype A and Respiratory Syncytial Virus subtype B, Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus, Human Metapneumovirus, Rhinovirus, and Adenovirus.
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 78 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K242613 | NxTAG® Respiratory Pathogen Panel | Oct 02, 2024 | Substantially Equivalent | Luminex Molecular Diagnostics, Inc. |
| K232775 | ID NOW Influenza A & B 2 | Oct 10, 2023 | Substantially Equivalent | Abbott Diagnostics Scarborough, Inc. |
| K231017 | Panther Fusion AdV/hMPV/RV Assay | May 05, 2023 | Substantially Equivalent | Hologic, Inc. |
| K213822 | cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System | Jul 06, 2022 | Substantially Equivalent | Roche Molecular Systems, Inc. |
| K210234 | cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System | Feb 16, 2021 | Substantially Equivalent | Roche Molecular Systems, Inc. |
| K201505 | Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack | Aug 22, 2020 | Substantially Equivalent | DiaSorin Molecular LLC |
| K200065 | 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 | Feb 10, 2020 | Substantially Equivalent | Roche Molecular Systems, Inc. |
| K192485 | BioCode Respiratory Pathogen Panel (RPP) | Dec 23, 2019 | Substantially Equivalent | Applied BioCode, Inc. |
| K193167 | NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software | Dec 11, 2019 | Substantially Equivalent | Luminex Molecular Diagnostics, Inc. |
| K191729 | Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System | Jul 24, 2019 | Substantially Equivalent | Roche Molecular Systems, Inc. |
| K191534 | ID NOW Influenza A & B 2 | Jul 11, 2019 | Substantially Equivalent | Abbott Diagnostics Scarborough, Inc. |
| K183597 | QIAstat-Dx Respiratory Panel | May 18, 2019 | Substantially Equivalent | QIAGEN GmbH |
| K181443 | Accula RSV Test | Nov 23, 2018 | Substantially Equivalent | Mesa Biotech, Inc. |
| K181289 | 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 | Aug 15, 2018 | Substantially Equivalent | Cepheid |
| K180218 | Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV | Jul 24, 2018 | Substantially Equivalent | Cepheid |
| K173932 | Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 | Jan 26, 2018 | Substantially Equivalent | Alere Scarborough, Inc. |
| K171552 | Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV | Dec 19, 2017 | Substantially Equivalent | Cepheid |
| K172629 | Panther Fusion AdV/hMPV/RV Assay | Dec 04, 2017 | Substantially Equivalent | Hologic, Inc. |
| K171974 | Solana RSV+hMPV Assay | Oct 16, 2017 | Substantially Equivalent | Quidel Corporation |
| K171792 | Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit | Sep 29, 2017 | Substantially Equivalent | Alere Scarborough, Inc. |
| K171963 | Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusion Specimen Lysis Tubes | Sep 26, 2017 | Substantially Equivalent | Hologic, Inc. |
| K163628 | Idylla Respiratory (IFV-RSV) Panel | Aug 30, 2017 | Substantially Equivalent | JANSSEN PHARMACEUTICA NV |
| K163636 | ePlex Respiratory Pathogen Panel | Jun 09, 2017 | Substantially Equivalent | GENMARK DIAGNOSTICS, INCORPORATED |
| K170604 | FilmArray Respiratory Panel 2 (RP2) | May 30, 2017 | Substantially Equivalent | BioFire Diagnostics, LLC |
| K162456 | 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 | Feb 13, 2017 | Substantially Equivalent | CEPHEID |
| K162331 | 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 | Feb 09, 2017 | Substantially Equivalent | CEPHEID |
| K163266 | Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument | Dec 21, 2016 | Substantially Equivalent | ALERE SCARBOROUGH, INC. |
| K152579 | FilmArray Respiratory Panel EZ (RP EZ) | Oct 03, 2016 | Substantially Equivalent | BIOFIRE DIAGNOSTICS, LLC |
| K161814 | Solana Influenza A+B Assay | Sep 27, 2016 | Substantially Equivalent | Quidel Corporation |
| K161375 | Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit | Aug 18, 2016 | Substantially Equivalent | ALERE SCARBOROUGH, INC. |
| K161220 | ARIES® Flu A/B & RSV Assay | Aug 02, 2016 | Substantially Equivalent | LUMINEX CORPORATION |
| K153544 | cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System | Jul 25, 2016 | Substantially Equivalent | IQuum, Inc. |
| K160068 | FilmArray Respiratory Panel (RP) for use with FilmArray Torch | Feb 08, 2016 | Substantially Equivalent | BioFire Diagnostics, LLC |
| K152386 | NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software | Dec 17, 2015 | Substantially Equivalent | LUMINEX MOLECULAR DIAGNOSTICS, INC. |
| K151226 | Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I) | Dec 03, 2015 | Substantially Equivalent | CEPHEID |
| K153219 | ProFlu+ Assay | Nov 20, 2015 | Substantially Equivalent | HOLOGIC, INC. |
| K152523 | JBAIDS Influenza A & B Detection Kit | Oct 01, 2015 | Substantially Equivalent | U.S. ARMY MEDICAL MATERIEL DEVELOPMENT ACTIVITY |
| K152408 | Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack | Sep 21, 2015 | Substantially Equivalent | FOCUS DIAGNOSTICS, INC. |
| K143653 | Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) | Sep 04, 2015 | Substantially Equivalent | NANOSPHERE, INC |
| K151464 | Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab Kit | Jul 28, 2015 | Substantially Equivalent | ALERE SCARBOROUGH, INC. |
| K143080 | FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray System | Feb 17, 2015 | Substantially Equivalent | BioFire Diagnostics, LLC |
| K142365 | Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack | Dec 05, 2014 | Substantially Equivalent | FOCUS DIAGNOSTICS |
| K142045 | XPERT FLU/RSV XC ASSAY | Nov 22, 2014 | Substantially Equivalent | CEPHEID |
| K141931 | LYRA ADENOVIRUS ASSAY | Oct 09, 2014 | Substantially Equivalent | QUIDEL CORPORATION |
| K141520 | ALERE I INFLUENZA A & B | Jun 13, 2014 | Substantially Equivalent | ALERE SCARBOROUGH, INC D/B/A BINAX, INC. |
| K131813 | QUIDEL MOLECULAR RSV + HMPV ASSAY | Sep 06, 2013 | Substantially Equivalent | QUIDEL CORP. |
| K131584 | IMDX FLU A/B AND RSV FOR ABBOTT M2000 | Aug 21, 2013 | Substantially Equivalent | INTELLIGENT MEDICAL DEVICES, INC |
| K132159 | PROADENO+ ASSAY | Aug 14, 2013 | Substantially Equivalent | GEN-PROBE PRODESSE, INC |
| K132129 | PRODESSE PROFLU+ ASSAY | Aug 09, 2013 | Substantially Equivalent | GEN-PROBE PRODESSE, INC. |
| K123620 | FILMARRAY RESPIRATORY PANEL (RP) | Feb 11, 2013 | Substantially Equivalent | BIOFIRE DIAGNOSTICS, INC. |
| K121942 | ADENOVIRUS R-GENE US | Feb 08, 2013 | Substantially Equivalent | ARGENE SA |
| K123191 | XPERT FLU | Dec 21, 2012 | Substantially Equivalent | CEPHEID |
| K121003 | ABBOTT PLEX-ID FLU ASSAY | Dec 21, 2012 | Substantially Equivalent | ABBOTT LABORATORIES |
| K120413 | SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK | Jul 13, 2012 | Substantially Equivalent | FOCUS DIAGNOSTICS, INC. |
| K120267 | FILMARRAY RP PANEL | May 15, 2012 | Substantially Equivalent | IDAHO TECHNOLOGY, INC. |
| K112781 | TAG RESPIRATORY VIRAL PANEL TAG DATA ANALYSIS SOFTWARE (TDAS RVP-I) | Feb 17, 2012 | Substantially Equivalent | LUMINEX MOLECULAR DIAGNOSTICS, INC. |
| K113323 | ARTUS INFL A/B RG RT-PCR KIT | Feb 06, 2012 | Substantially Equivalent | QIAGEN, GMBH |
| K112172 | QUIDEL MOLECULAR INFLUENZA A + B ASSAY | Dec 22, 2011 | Substantially Equivalent | QUIDEL CORP. |
| K111775 | JBAIDS INFLUENZA A&B DETECTION KIT | Sep 13, 2011 | Substantially Equivalent | U.S. ARMY MEDICAL MATERIAL DEVELOPMENT ACITVITY |
| K112199 | XTAG RESPIRATORY VIRAL PANEL, XTAG DATA ANALYSIS SOFTWARE (TDAS RVP-1) | Sep 01, 2011 | Substantially Equivalent | LUMINEX MOLECULAR DIAGNOSTICS, INC. |
| K111387 | LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER | Aug 04, 2011 | Substantially Equivalent | IQUUM INC |
| K103776 | XTAG RESPIRATORY VIRAL PANEL FAST, XTAG DATA ANALYSIS SOFTWARE FOR RVP FAST | Jul 01, 2011 | Substantially Equivalent | LUMINEX MOLECULAR DIAGNOSTICS, INC. |
| K110968 | PROFLU+ ASSAY | Jun 27, 2011 | Substantially Equivalent | GEN-PROBE PRODESSE, INC |
| K110764 | FILMARRAY RP PANEL | Apr 27, 2011 | Substantially Equivalent | IDAHO TECHNOLOGY, INC. |
| K103175 | FILMARRAY RESPIRATORY PANEL (RP) | Feb 17, 2011 | Substantially Equivalent | IDAHO TECHNOLOGY, INC. |
| K103209 | VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+) | Jan 10, 2011 | Substantially Equivalent | NANOSPHERE, INC. |
| K102952 | PRODESSE PROADENO | Dec 03, 2010 | Substantially Equivalent | GEN-PROBE PRODESSE, INC |
| K102170 | SIMPLEXA FLU A/B & RSV | Nov 24, 2010 | Substantially Equivalent | FOCUS DIAGNOSTICS, INC. |
| K093337 | VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM | Nov 17, 2009 | Substantially Equivalent | NANOSPHERE, INC |
| K092957 | VERIGENE SYSTEM, VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST | Oct 21, 2009 | Substantially Equivalent | NANOSPHERE, INC |
| K092566 | VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM (RVNATSP) | Oct 09, 2009 | Substantially Equivalent | NANOSPHERE, INC |
| K092500 | MODIFICATION TO PROFLU+ ASSAY | Aug 20, 2009 | Substantially Equivalent | PRODESSE, INC. |
| K091667 | XTAG RESPIRATORY VIRAL PANEL, MODELS I019A0110, I019C011, I019D0112, I019E0113, S019-0116 | Jun 25, 2009 | Substantially Equivalent | LUMINEX MOLECULAR DIAGNOSTICS, INC. |
| K083088 | VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST | May 01, 2009 | Substantially Equivalent | NANOSPHERE, INC |
| K081483 | XTAG RESPIRATORY VIRAL PANEL | Jun 25, 2008 | Substantially Equivalent | LUMINEX MOLECULAR DIAGNOSTICS, INC. |
| K081030 | MODIFICATION TO PROFLU+ ASSAY | May 02, 2008 | Substantially Equivalent | PRODESSE, INC. |
| K073029 | PROFLU+ ASSAY | Jan 04, 2008 | Substantially Equivalent | PRODESSE, INC. |
| DEN070013 | ID-TAG RESPIRATORY VIRAL PANEL | Jan 03, 2008 | Unknown | LUMINEX MOLECULAR DIAGNOSTICS, INC. |
FEI Numbers
This FDA classification entry is associated with 29 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 29 registration numbers. Click on an entry to view related FDA registrations.