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510(k) Data Aggregation

    K Number
    K242209
    Device Name
    UASure II Blood Uric Acid Monitoring System
    Manufacturer
    Apex Biotechnology Corp
    Date Cleared
    2025-04-04

    (249 days)

    Product Code
    PTC
    Regulation Number
    862.1775
    Why did this record match?
    Product Code :

    PTC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This UASure II Blood Uric Acid Monitoring System measures blood uric acid levels in fresh capillary whole blood drawn from fingertips. It is intended for single-patient home use by prescription and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use) by people with gout as an aid to monitor the effectiveness of uric acid control. The UASure II Blood Uric Acid Monitoring System helps track uric acid levels but does not diagnose Hyperuricemia or Gout. Do not change medications based on test results without talking to a doctor. The UASure II Blood Uric Acid Monitoring System includes the UASure II Meter, UASure II Blood Uric Acid Test Strips and UASure II Uric Acid Control Solution.
    Device Description
    The UASure II Blood Uric Acid Monitoring System consists of the UASure II Blood Uric Acid Meter, UASure II Blood Uric Acid Test Strip and UASure II Uric Acid control solution. It is used for testing of blood uric acid by self-testers at home use by prescription only. The UASure II Blood Uric Acid Test Strip and UASure II Uric Acid control solution are purchased separately.
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    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
    Why did this record match?
    Product Code :

    PTC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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.
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    K Number
    K160990
    Device Name
    Nova Max Uric Acid Monitoring System
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Date Cleared
    2017-04-11

    (368 days)

    Product Code
    PTC
    Regulation Number
    862.1775
    Why did this record match?
    Product Code :

    PTC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nova Max Uric Acid Monitoring System consists of Nova Max Uric Acid Monitor, Nova Max Uric Acid Test Strips and Nova Max Uric Acid Control Solutions. The Nova Max Uric Acid Monitoring System is intended to the quantitative measurement of Uric Acid in fresh capillary whole blood obtained from the fingertip of gout patients. It is intended for single-patient home use by prescription and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use) by people with gout as an aid to monitor the effectiveness of Uric Acid control. It is intended for use by patients undergoing treatment for gout or the order of a treating healthcare professional. This system should not be used to alter gout treatment by changing any medication schedule or dosage unless specifically instructed by a healthcare professional. This system should only be used with single-use, auto-disabling Lancing Devices. It should only be used with Nova Max Uric Acid Test Strips and Nova Max Uric Acid Control Solutions.
    Device Description
    The Nova Max Uric Acid Monitoring System uses selective mediated enzymatic action (uricase biosensor) to generate current across the electrodes. The current generated is proportional to the concentration of Uric Acid in the whole blood sample. The device, which is amperometric, measures the Uric Acid concentration in the whole blood sample by measuring the amount of current that was generated and flows through the electrodes on the Test Strips. The Nova Max Uric Acid Monitoring System is comprised of Nova Max Uric Acid Test Strips, a portable handheld Nova Max Uric Acid Monitor, and Nova Max Uric Acid Control Solutions. Monitor Power Supply: The monitor uses single (3V) lithium, non-rechargeable battery. The battery life is approximately 1,000 tests. No-Coding System: The user is not required to enter a Test Strip lot-specific Calibration Code into the monitor by pressing a button or by inserting a Code Key. Uric Acid Control Solutions are aqueous assayed solutions, containing buffered Uric Acid, preservatives, FD & C dye, and viscosity additive. They contain no products of human origin. There are three levels of controls (level 1, 2, and 3). Safety Lancets are provided as an accessory to the Nova Max Uric Acid Monitoring System. They are commercially available single-use, auto disabling sterilized Lancing Devices.
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