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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: OCC FDA class 2

    Respiratory Virus Panel Nucleic Acid Assay System

    Microbiology

    View full classification →

    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) Clearances

    50+ matches
    K Number
    Device Name
    NxTAG® Respiratory Pathogen Panel
    ID NOW Influenza A & B 2
    Panther Fusion AdV/hMPV/RV Assay
    cobas Influenza A/B & RSV 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
    Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack
    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
    BioCode Respiratory Pathogen Panel (RPP)
    NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software
    Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System
    ID NOW Influenza A & B 2
    QIAstat-Dx Respiratory Panel
    Accula RSV Test
    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
    Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV
    Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2
    Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV
    Panther Fusion AdV/hMPV/RV Assay
    Solana RSV+hMPV Assay
    Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit
    Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusion Specimen Lysis Tubes
    Idylla Respiratory (IFV-RSV) Panel
    ePlex Respiratory Pathogen Panel
    FilmArray Respiratory Panel 2 (RP2)
    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
    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
    Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument
    FilmArray Respiratory Panel EZ (RP EZ)
    Solana Influenza A+B Assay
    Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit
    ARIES® Flu A/B & RSV Assay
    cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System
    FilmArray Respiratory Panel (RP) for use with FilmArray Torch
    NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software
    Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I)
    ProFlu+ Assay
    JBAIDS Influenza A & B Detection Kit
    Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack
    Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)
    Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab Kit
    FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray System
    Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack
    XPERT FLU/RSV XC ASSAY
    LYRA ADENOVIRUS ASSAY
    ALERE I INFLUENZA A & B
    QUIDEL MOLECULAR RSV + HMPV ASSAY
    IMDX FLU A/B AND RSV FOR ABBOTT M2000
    PROADENO+ ASSAY
    PRODESSE PROFLU+ ASSAY
    FILMARRAY RESPIRATORY PANEL (RP)

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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