BEUDAMED
    Product Code: NWG FDA class 2 21 CFR 866.5660

    Autoantibodies, Glutamic Acid Decarboxylase (Gad)

    Immunology

    The Autoantibodies, Glutamic Acid Decarboxylase (GAD) device is an in vitro diagnostic immunoassay used for the semi-quantitative determination of glutamic acid decarboxylase (GAD) autoantibodies in human serum, serving as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune-mediated diabetes). It falls under FDA Class 2, meaning it requires a 510(k) premarket notification to demonstrate substantial equivalence to a legally marketed predicate device. The product code is NWG, regulated under 21 CFR 866.5660, and falls within the Immunology medical specialty. Third-party 510(k) review is available for this device type.

    View on FDA
    510(k)s
    2
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    1
    Years Active
    2

    Research product code NWG in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    NWG
    Device Class
    FDA class 2
    Regulation Number
    866.5660
    Medical Specialty
    Immunology
    Review Panel
    IM
    Submission Type
    1

    Device Characteristics

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

    Definition

    The device is used for the semi-quantitative determination of glutamic acid decarboxylase (GAD) autoantibodies in human serum as an aid in the diagnosis of Type I diabetes mellitus (autoimmune mediated diabetes).

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 2 510(k) clearances via K numbers.

    K Number Device Name
    K072135 KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT
    K051061 KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KIT

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.