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510(k) Data Aggregation

    K Number
    K181675
    Device Name
    FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System
    Manufacturer
    TaiDoc Technology Corporation
    Date Cleared
    2018-12-10

    (168 days)

    Product Code
    PTC,LFQ
    Regulation Number
    862.1775
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K832785
    Why did this record match?
    Device Name :

    FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Prescription home use: The FORA MD6 Uric Acid Monitoring System is intended for the quantitative measurement of uric acid in capillary whole blood from the fingertip. It is intended foruse outside the body (in vitro diagnostic use) by people with hyperuricemia or gout as an aid to monitor the effectiveness of uric acid control. The system is intended for single-patient home use by prescription only and should not be shared. The system should only be used with FORA MD6 Uric Acid Test Strips, and FORA Uric Acid Control Solutions.

    The system should not be used to alter hyperuricemia or gout treatment by changing any medication schedule or dosage unless specifically instructed by a healthcare professional.

    Point-of-care use: The FORA MD6 Pro Uric Acid Monitoring System is intended for the quantitative measurement of uric acid in capillary whole blood from the fingertip. This system should only be used with single-use, auto-disabling lancing devices. It is for in vitro diagnostic use only.

    This system is intended for multiple patient use by health care professionals at point of care sites as an aid to monitor the effectiveness of uric acid control in people with hyperuricemia or gout

    Device Description

    FORA MD6/ FORA MD6 Pro Uric Acid Monitoring System includes the FORA MD6/ FORA MD6 Pro Meter, the FORA MD6/ FORA MD6 Pro Uric Acid Test Strips and the Uric Acid Control Solutions.

    AI/ML Overview

    The provided text does not contain detailed acceptance criteria and the results of a study proving the device meets those criteria. It is a 510(k) summary for the FORA MD6 Uric Acid Monitoring System and FORA MD6 Pro Uric Acid Monitoring System, which states that performance studies were conducted, but it does not specify the acceptance criteria or report the detailed performance metrics from those studies.

    Therefore, I cannot provide the requested information based on the given input. The document generally states that the studies "demonstrated that the intended users can obtain uric acid results that are substantially equivalent to the current methods for uric acid measurements," but it lacks specific quantitative acceptance criteria and detailed performance data.

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