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510(k) Data Aggregation

    K Number
    K051936
    Device Name
    CLEVER CHECK TD-3215/DR. T TD-3216 BLOOD GLUCOSE AND BLOOD PRESSURE MEASUREMENT SYSTEMS
    Manufacturer
    TaiDoc Technology Corporation
    Date Cleared
    2005-08-08

    (21 days)

    Product Code
    NBW
    Regulation Number
    862.1345
    Type
    Special
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    These Clever Chek TD-3215"M / Dr. T TD-3216"M Blood Glucose and Blood Pressure Measurement Systems are intended for in vitro diagnostic use. These systems are intended to be used for the quantitative measurement of glucose in capillary whole blood from the fingertip. They are intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. They are not intended for the diagnosis of or screening for diabetes mellitus, and not intended for use on neonates. These systems are also intended to be used to measure non-invasively the systolic and diastolic blood pressure and pulse rate of an adult individual, over age 16, at home by using a technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 5.25"~7.75".

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) summary for a blood glucose and blood pressure measurement system. It does not contain a detailed study report with acceptance criteria and device performance as requested. The document primarily focuses on the FDA's regulatory decision regarding substantial equivalence to a predicate device.

    Therefore, I cannot extract the specific information requested about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment from this document.

    The document does state the "Indications for Use" for the device:

    • Blood Glucose Measurement: For in vitro diagnostic use, quantitative measurement of glucose in capillary whole blood from the fingertip. Intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. Not intended for diagnosis or screening for diabetes mellitus, and not for use on neonates.
    • Blood Pressure Measurement: To measure non-invasively the systolic and diastolic blood pressure and pulse rate of an adult individual (over age 16) at home using an inflatable cuff around the wrist. Cuff circumference is limited to 5.25"~7.75".
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