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510(k) Data Aggregation

    K Number
    K142035
    Device Name
    GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, RELION MICRO BLOOD GLUCOSE MONITORING SYSTEM
    Manufacturer
    ARKRAY FACTORY INC.
    Date Cleared
    2014-09-05

    (39 days)

    Product Code
    NBW,CGA
    Regulation Number
    862.1345
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K082417
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The GLUCOCARD 01-mini Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home by persons with diabetes as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. It is intended for single patient use and should not be shared with other individuals.

    The GLUCOCARD 01 SENSOR PLUS Blood Glucose Test Strips are intended to be used with the GLUCOCARD 01-mini Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm.

    The ReliOn Micro Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home by persons with diabetes as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. It is intended for single patient use and should not be shared with other individuals.

    The ReliOn Micro Plus Blood Glucose Test Strips are intended to be used with the ReliOn Micro Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm.

    Device Description

    The GLUCOCARD 01-mini Blood Glucose Monitoring System and ReliOn Micro Blood Glucose Monitoring System consist of a meter, test strips, and control solution for use as an aid to monitor the effectiveness of diabetes control.

    AI/ML Overview

    This document describes the 510(k) premarket notification for the GLUCOCARD 01-mini Blood Glucose Monitoring System and the ReliOn Micro Blood Glucose Monitoring System, which are intended for quantitative measurement of glucose in fresh capillary whole blood samples.

    Here's the breakdown of the acceptance criteria and study information:

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided document does not explicitly state the quantitative acceptance criteria for system accuracy in a table format, nor does it provide detailed numerical results of the device's performance against such criteria. It generally states that a "clinical study was done with persons with diabetes to evaluate system accuracy."

    However, glucose monitoring systems like this are typically evaluated against standards like ISO 15197 for accuracy. A common acceptance criterion for blood glucose meters, as per ISO 15197, often includes:

    • 95% of results falling within ±15 mg/dL of the reference method for glucose concentrations
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