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510(k) Data Aggregation

    K Number
    K061234
    Device Name
    GLUCOPLUS BLOOD GLUCOSE MONITORING SYSTEM
    Manufacturer
    GLUCOPLUS INC
    Date Cleared
    2006-10-30

    (181 days)

    Product Code
    NBW,CGA,JJX
    Regulation Number
    862.1345
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    k964630
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Glucoplus™ Blood Glucose Test System is comprised of Control Solutions and Test Strip biosensors for use only with the Glucoplus™ Blood Glucose Meter. It is for quantitative measurement of the concentration of glucose in capillary whole blood taken from the fingerstick by people with diabetes at home and/or by healthcare professionals in a clinical setting 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.

    Device Description

    GlucoPlus™ Blood Glucose Monitoring System is comprised of an electrchemical biosensor glucose reagent test strip, a hand held meter, quality control solutions, a user manual, a check strip, a lancet, lancets and a logbook for recording test results. When the user inserts a test strip , the meter turns on. The user acquires a blood sample by touching the aperture of the test strip to the finger tip blood drop to fill the chamber on the strip. The meter sounds a beep to let the user know that the sample chamber is full and the reaction has begun. When the test is complete, the meter displays the glucose reading on its LCD.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study that demonstrates the GlucoPlus device meets them, based on the provided 510(k) summary:

    1. Table of Acceptance Criteria and Reported Device Performance:

    The document doesn't explicitly state "acceptance criteria" in a bulleted or numbered list. Instead, it presents system accuracy results, which are essentially the performance metrics against which the device's accuracy is judged. For blood glucose meters, these typically involve how close the meter's reading is to a reference method (like YSI). The FDA guidance for blood glucose meters at the time (though not explicitly cited as such here) often referenced ISO 15197 for system accuracy.

    Here's an interpretation of the implied acceptance criteria from the "System accuracy results" section and the reported performance:

    Acceptance Criterion (Implied from Performance Reporting)Reported Device Performance (GlucoPlus™)
    **For Glucose 0.98) and the overall system accuracy results, particularly 100% within 15 mg/dL for low glucose and 93% within ±15% for high glucose (with 98.8% within ±20%), are generally indicative of acceptable performance for blood glucose monitoring systems at the time of this submission. The FDA's clearance implies these results met their criteria.

    2. Sample Sizes and Data Provenance:

    • Test Set Sample Size:
      • Consumer Study (Lay Users): N = 120 specimens
      • Consumer Study (Technician): N = 120 specimens
      • Point of Care Study: N = 200 specimens (broken down as: Home Medical (58), Metabolism (62), Internal (80))
      • System Accuracy: Based on the detailed breakdown: 28 measurements for glucose
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