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    K Number
    K033627
    Device Name
    Q.STEPS BIOMETER G BLOOD GLUCOSE MONITORING SYSTEM
    Manufacturer
    BIOMEDIX, INC.
    Date Cleared
    2004-05-21

    (184 days)

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

    Q.STEPS BIOMETER G BLOOD GLUCOSE MONITORING SYSTEM

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

    The Q.STEPS™ Biometer G Blood Glucose Monitoring System is intended to be used for quantitative measurement of glucose in fresh capillary whole blood from the fingertip for all ages (excluding neonates.) It is intended for use outside the body (for in vitro diagnostic use) by health care professionals in settings such as clinical laboratories and physician offices laboratories (POLs) as an aid to monitor the effectiveness of diabetes control.

    Device Description

    The Q.STEPS™ Biometer G Blood Glucose Monitoring System is an in vitro device designed for measuring the concentration of glucose in capillary whole blood from the fingertip. The system uses electrochemical methodology. The system quantifies glucose amperometrically by measuring the current that is produced when glucose oxidase catalyzes the oxidation of glucose to gluconic acid. The electrons generated during this reaction are transferred from the blood to the electrodes. The magnitude of the resultant current is proportional to the concentration of glucose in the specimen and is converted to a readout displayed on the monitor.

    AI/ML Overview

    Here's an analysis of the acceptance criteria and study detailed in the provided document for the Q.STEPS™ Biometer G Blood Glucose Monitoring System:

    1. Table of Acceptance Criteria and Reported Device Performance

    Performance MetricAcceptance Criteria (Explicitly Stated or Implied by Context)Reported Device Performance
    LinearityGood linearity through a wide range (implied to be clinically relevant for glucose monitoring)Good through a wide range of 50 to 400 mg/dl. Confirmed with internal laboratory and external clinical studies.
    Accuracy (Agreement with Reference Method)Bias within 20 mg/dl (for Blood Glucose 95% (or similar high percentage) in Zones A & B of Clarke Error Grid.All data collected fall well within the acceptance criteria of a bias within 20 mg/dl (Blood Glucose
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