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    K Number
    K111728
    Device Name
    EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
    Manufacturer
    EPS BIO TECHNOLOGY CORP.
    Date Cleared
    2011-09-16

    (88 days)

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

    EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM

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

    The EMV3 Pro Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in fresh capillary whole blood from fingertip. Testing is done outside the body (In Vitro diagnostic use). It is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus.

    The EMV3 Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in fresh capillary whole blood from fingertip or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.

    Device Description

    The system consists of the EMV3 Pro meter and the EMV3 Pro test strips. The EMV3 Pro meter only is used with the EMV3 Pro test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip.

    The system consists of the EMV3 meter and the EMV3 test strips. The EMV3 meter only is used with the EMV3 test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip or forearm.

    AI/ML Overview

    This document is a 510(k) premarket notification from the FDA, specifically concerning two self-monitoring blood glucose systems: EMV3 Pro and EMV3. It does not contain information about the acceptance criteria or reported device performance in the format requested. The document outlines the indications for use for both devices and confirms their substantial equivalence to legally marketed predicate devices. It provides regulatory information and contact details, but no study details or performance metrics.

    Therefore, I cannot provide the requested information based on the provided text.

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