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510(k) Data Aggregation

    K Number
    K140141
    Device Name
    LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM
    Manufacturer
    CERAGEM MEDISYS INC.
    Date Cleared
    2014-07-03

    (162 days)

    Product Code
    NBW,CGA
    Regulation Number
    862.1345
    Type
    Special
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K102751
    Why did this record match?
    Reference Devices :

    K102751

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

    The LabonaCheck® Gluppy Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The LabonaCheck® Gluppy Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

    The LabonaCheck® Gluppy Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The LabonaCheck® Gluppy Blood Glucose Monitoring System should not be used for the diagnosis or screening of diabetes or for neonatal use.

    The LabonaCheck® Gluppy Blood Glucose Test Strips are for use with the LabonaCheck® Gluppy Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.

    Device Description

    The system consists of Test Meter, Test Strips, Lancing Device, lancets, 3 V battery and Carrying Case. The system measures the amount of glucose (sugar) in whole blood. Blood is applied to the absorbent hole of the test strip and automatically drawn into the reaction zone where reaction between reagent and glucose occurs.

    AI/ML Overview

    The provided text is a 510(k) summary for the LabonaCheck® Gluppy Blood Glucose Monitoring System. It does not contain information about the specific acceptance criteria, a study proving the device meets those criteria, or details regarding sample sizes for training/test sets, ground truth establishment, or expert involvement as requested.

    The document primarily focuses on establishing substantial equivalence to a predicate device (K102751) by comparing various features and performance characteristics. It states that the "Performance Characteristics" are the same as the predicate and refers to "N. Performance Characteristics on 6 page" which is not provided in the input text.

    Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria, study design, and performance results. This document is a regulatory submission for premarket notification, not a detailed scientific study report.

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