BEUDAMED
    Product Code: NGZ FDA class 2 21 CFR 866.1640

    Susceptibility Test Plate, Antifungal

    Microbiology

    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.

    View on FDA
    510(k)s
    21
    FEI Numbers
    8
    Registration Numbers
    8
    Unique Applicants
    6
    Years Active
    23

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    Basic Information

    Product Code
    NGZ
    Device Class
    FDA class 2
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Review Panel
    MI
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    The device is an in vitro diagnostic device intended for use in determining quantitative susceptibility of Candida species to various antifungal agents diluted in varying concentration in a microtiter plate format.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 21 510(k) clearances via K numbers.

    K Number Device Name
    K243738 The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL
    K232967 VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)
    K232963 VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)
    K231433 The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL
    K221198 Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL
    K221899 The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml
    K211539 Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mL
    K181368 VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL)
    K151923 VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL)
    K151817 VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL
    K133952 VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINE
    K133817 VITEK 2 AST - YEAST FLUCONAZOLE
    K133038 SENSITITRE YEASTONE SUSCEPTIBILITY PLATES
    K101566 VITEK 2 YEAST CASPOFUNGIN
    K092454 VITEK 2 YEAST VORICONAZOLE
    K082534 ETEST VORICONAZOLE 0.002-32 UG/ML
    K090968 SENSITITRE YEASTONE SUSCEPTIBILITY PLATES
    K081063 SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS
    K061945 VITEK 2 AST-YS FLUCONAZOLE
    K040560 ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING
    K991810 MODIFICATION TO SENSITITRE YEASTONE MIC SUSCEPTIBILITY TEST

    FEI Numbers

    This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.