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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: PSZ FDA class 2

    Devices Detecting Influenza A, B, And C Virus Antigens

    Microbiology

    View full classification →

    The Devices Detecting Influenza A, B, and C Virus Antigens are qualitative in vitro diagnostic systems intended for the rapid detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection, aiding in the diagnosis of influenza A, B, and C. They are classified as FDA Class 2 under 21 CFR 866.3328 in the Microbiology specialty, requiring 510(k) premarket notification. Product code PSZ; not an implant and not life-sustaining.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Innovita Flu A/B Antigen Rapid Test
    Acucy® Influenza A&B Test with the Acucy® 2 System
    BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit
    BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit
    Osom Ultra Plus Flu A&B Test Kit
    CareStart Flu A&B Plus
    Acucy Influenza A&B Test with the Acucy System
    BioSign Flu A+B
    Alere BinaxNOW Influenza A & B Card 2, Alere Reader
    BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit
    QuickVue Influenza A+B
    Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit
    Sofia Influenza A+B FIA on Sofia 2
    Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit
    BD Veritor System for Rapid Detection of Flu A + B Labratory Kit
    BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit
    Sofia Influenza A+B FIA
    BD Veritor System for the Rapid Detection of Flu A + B CLIA waived kit
    BD Veritor System for the Rapid Detection of Flu A + B Laboratory kit
    BD Veritor (TM) System for the Rapid Detection of Flu A+B
    BD Veritor™ System Flu A+B Assay
    TRU FLU
    ALERE INFLUENZA A & B TEST
    BIOSIGN FLU A + B, STATUS FLU A & B
    BD Veritor™ System Flu A+B Assay
    BD Veritor™ System Flu A+B Assay
    BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
    BIOSIGN FLU A + B, STATUS FLU A & B
    BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
    BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
    BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B
    BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
    BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B
    SOFIA ANALYZER AND INFLUENZA A+B FIA
    CLEARVIEW EXACT II INFLUENZA A & B TEST
    BIOSIGN FLU A+B
    BD DIRECTIGEN EX FLU A+B
    BD DIRECTIGEN EZ FLU A+B ASSAY
    CLEARVIEW EXACT II INFLUENZA A & B TEST
    SAS FLUALERT A&B, SAS INFLUENZA A TEST
    MODIFICATION TO: RAMP INFLUENZA A/B ASSAY
    OSOM INFLUENZA A&B TEST , MODEL PN190
    QUICKVUE INFLUENZA A+B TEST
    TRU FLU, MODEL 751230
    XPECT FLU A & B
    MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST
    SAS INFLUENZA A & B TEST
    RAMP INFLUENZA A/B ASSAY
    TRU FLU
    BD DIRECTIGEN EZ FLU A+B TEST

    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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