BEUDAMED
    Product Code: PTC FDA class 1 21 CFR 862.1775

    Uric Acid Test System For At Home Prescription Use

    Clinical Chemistry

    The Uric Acid Test System for At Home Prescription Use is a prescription-only in vitro diagnostic device for the quantitative measurement of uric acid levels in home use settings, intended for patients diagnosed with gout to monitor their uric acid levels for disease management. It is classified as FDA Class 1 under 21 CFR 862.1775 in the Clinical Chemistry specialty, subject to general controls only, and is eligible for third-party review. Product code PTC; not an implant and not life-sustaining.

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    510(k)s
    3
    FEI Numbers
    5
    Registration Numbers
    5
    Unique Applicants
    3
    Years Active
    8

    Basic Information

    Product Code
    PTC
    Device Class
    FDA class 1
    Regulation Number
    862.1775
    Medical Specialty
    Clinical Chemistry
    Review Panel
    CH
    Submission Type
    1

    Device Characteristics

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

    Definition

    For the quantitative measurement of uric acid in home use settings by patients diagnosed with gout. This device is for prescription use only.

    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
    K242209 UASure II Blood Uric Acid Monitoring System
    K181675 FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System
    K160990 Nova Max Uric Acid Monitoring System

    FEI Numbers

    This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.