BEUDAMED
    Product Code: QRF FDA class 3

    Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer

    Unknown

    The Multi-Analyte Test System with Algorithmic Analysis for Detection of Prostate Cancer is an in vitro diagnostic test system that combines values from multiple assays, with or without additional patient information, to yield a score aiding in the detection of prostate cancer or guiding decisions regarding prostate biopsy. It requires PMA approval as an FDA Class 3 device, reflecting the high risk associated with cancer diagnostic decisions. There is no assigned regulation number, and it is reviewed under the Immunology panel. The device is not an implant and not life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    QRF
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    IM
    Submission Type
    2

    Device Characteristics

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

    Definition

    Test system that combines values from multiple assays with/without other patient information to yield a score value for aid in detection of prostate cancer and/or decision for prostate biopsy.

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.