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510(k) Data Aggregation

    K Number
    K073118
    Device Name
    PRODIGY VOICE BLOOD GLUCOSE MONITORING SYSTEM
    Manufacturer
    DIAGNOSTIC DEVICES INC.
    Date Cleared
    2008-03-05

    (121 days)

    Product Code
    NBW, CGA
    Regulation Number
    862.1345
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIAGNOSTIC DEVICES INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Prodigy Voice Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus. The alternative site testing in this system can be used only during steady-state blood glucose conditions. This system contains a speaking functionality which provides step by step instructions to aid visually impaired persons.
    Device Description
    Prodigy Voice Blood Glucose Monitoring System consists of a meter and test strips. The system utilizes an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in fresh whole blood and control solutions. This system contains speaker function which provides step by step instructions.
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    K Number
    K053593
    Device Name
    PRODIGY
    Manufacturer
    DIAGNOSTIC DEVICES INC.
    Date Cleared
    2006-07-06

    (195 days)

    Product Code
    NBW, CGA, JJX
    Regulation Number
    862.1345
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIAGNOSTIC DEVICES INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Prodigy Blood Glucose Test System is intended for use in the quantitative measurement of glucose in whole blood taken from the finger. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and are not intended for use on neonates. The Prodigy Blood Glucose Test System is intended to be used for the quantitative measurement of glucose in capillary whole blood from the fingertip. It is intended for use by people with diabetes mellitus at home (Over -the-Counter) as an aid in monitoring the effectiveness of diabetes control program. The Prodigy blood glucose test system can also be used at clinical sites by nurses or professional people to test patient's glucose level in whole blood. It is not intended for the diagnosis of or screening for diabetes mellitus, and not intended for use on neonates. The Prodigy meter is to be used with the Prodigy Blood Glucose Test Strip, and the Prodigy Glucose Control Solutions.
    Device Description
    The Prodigy glucose test system consists of a meter and test strips. The system utilizes an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in fresh whole blood and control solutions.
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