LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K102345
    Device Name
    EASYMAX T1 SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS10042
    Manufacturer
    EPS BIO TECHNOLOGY CORP.
    Date Cleared
    2011-06-21

    (306 days)

    Product Code
    NBW,CGA
    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

    The EasyMax T1 Pro Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. Testing is done outside the body (In Vitro diagnostic use). It is indicated for multiple-patient use in a professional healthcare setting, 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. Alternative site testing can be only used during steady-state blood qlucose conditions.

    The system consists of the EasyMax T1 Pro Meter and the EasyMax T1 Pro Blood Glucose Test Strips. The EasyMax T1 Pro Meter is only used with the EasyMax T1 Pro Blood Glucose Test Strips to quantitatively measure glucose in fresh capillary whole blood samples drawn from fingertips.

    The EasyMax T1 Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips 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.

    The system consists of the EasyMax T1 Meter and the EasyMax T1 Blood Glucose Test Strips. The EasyMax T1 Meter is only used with the EasyMax T1 test strips to quantitatively measure glucose in fresh capillary whole blood samples drawn from fingertips or forearm.

    Device Description

    The system consists of the EasyMax T1 Pro Meter and the EasyMax T1 Pro Blood Glucose Test Strips. The EasyMax T1 Pro Meter is only used with the EasyMax T1 Pro Blood Glucose Test Strips to quantitatively measure glucose in fresh capillary whole blood samples drawn from fingertips.

    The system consists of the EasyMax T1 Meter and the EasyMax T1 Blood Glucose Test Strips. The EasyMax T1 Meter is only used with the EasyMax T1 test strips to quantitatively measure glucose in fresh capillary whole blood samples drawn from fingertips or forearm.

    AI/ML Overview

    Acceptance Criteria and Study for EasyMax TI Self Monitoring Blood Glucose System

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (CliniLabs Guidelines)Reported Device Performance (EasyMax TI System)
    ≥ 95% of results within ± 15 mg/dL or ± 15% of reference for glucose concentrations
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1