BEUDAMED
    Product Code: QSE FDA class 2 21 CFR 866.5840

    Alzheimer’S Disease Pathology Assessment Test

    Immunology

    The Alzheimer's Disease Pathology Assessment Test is an in vitro diagnostic device used to determine whether patients presenting with cognitive impairment who are being evaluated for Alzheimer's disease will test positive or negative for amyloid plaques or neurofibrillary tangles as measured by PET imaging agents. It provides objective biomarker data to support clinical evaluation of Alzheimer's pathology. Classified as FDA Class 2 under regulation 866.5840, it requires 510(k) clearance in the Immunology specialty. The device is not an implant and not life-sustaining.

    View on FDA
    510(k)s
    3
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    2
    Years Active
    1

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    Basic Information

    Product Code
    QSE
    Device Class
    FDA class 2
    Regulation Number
    866.5840
    Medical Specialty
    Immunology
    Review Panel
    IM
    Submission Type
    1

    Device Characteristics

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

    Definition

    In vitro test to determine whether a patient presenting with cognitive impairment and being evaluated for AD and other causes of cognitive decline will test positive or negative for amyloid plaques or neurofibrillary tangles as measured by PET imaging agents.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 3 510(k) clearances via K numbers.

    K Number Device Name
    K231348 Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF
    K221842 Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF
    DEN200072 Lumipulse G ß-Amyloid Ratio (1-42/1-40)

    FEI Numbers

    This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.