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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: NGZ FDA class 2

    Susceptibility Test Plate, Antifungal

    Microbiology

    View full classification →

    The Susceptibility Test Plate, Antifungal (product code NGZ) is an in vitro diagnostic device used to determine quantitative antifungal susceptibility of fungal organisms to various antifungal agents, guiding appropriate antifungal therapy selection, as described in its definition. It is classified as an FDA Class 2 device within the Microbiology specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. The device is not flagged as an implant or life-sustaining device.

    510(k) Clearances

    21 matches
    K Number
    Device Name
    The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL
    VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)
    VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)
    The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL
    Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL
    The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml
    Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mL
    VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL)
    VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL)
    VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL
    VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINE
    VITEK 2 AST - YEAST FLUCONAZOLE
    SENSITITRE YEASTONE SUSCEPTIBILITY PLATES
    VITEK 2 YEAST CASPOFUNGIN
    VITEK 2 YEAST VORICONAZOLE
    ETEST VORICONAZOLE 0.002-32 UG/ML
    SENSITITRE YEASTONE SUSCEPTIBILITY PLATES
    SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS
    VITEK 2 AST-YS FLUCONAZOLE
    ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING
    MODIFICATION TO SENSITITRE YEASTONE MIC SUSCEPTIBILITY 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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