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510(k) Data Aggregation

    K Number
    K123016
    Device Name
    VERI-Q SELF-TESTING AND VERI-Q PLUS MGD-2001 BLOOD GLUCOSE MONITORING SYSTEMS
    Manufacturer
    MICOBIOMED CO, LTD
    Date Cleared
    2013-06-18

    (264 days)

    Product Code
    NBW,CGA,JJX
    Regulation Number
    862.1345
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K083468
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Veri-Q self-testing MGD-2001 Blood Glucose Monitoring System is intended for use in The quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from fingertips, palm, or forearm. The Veri-Q self-testing MGD-2001 Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. The Veri-Q self-testing MGD-2001 Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Veri-Q sclf-testing MGD-2001 Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

    The Veri-Q self-testing MGS-01 test strips are for use with the Veri-Q self-testing MGD-2001 meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from fingertips, palm, or forearm.

    The Veri-O self-testing Glucose Control Solutions are for use with the Veri-Q self-testing MGD-2001 meter and the Veri-Q self-testing MGS-01 test strips to check that the meter and test strips are working together properly and providing accurate results.

    The Veri-Q plus MGD-2001 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose (sugar) in fresh capillary whole blood drawn from fingertips, palm, or forearm. The Veri-Q plus MGD-2001 Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use). The Veri-Q plus MGD-2001 Blood Glucose Monitoring System is intended for multi-patient use in a professional healthcare setting, as an aid to monitor the effectiveness of diabetes control. This system is only used with single-use, auto-disabling lancing devices. The Veri-O plus MGD-2001 Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

    The Veri-O plus MGS-01 test strips are for use with the Veri-Q plus MGD-2001 meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from fingertips, palm, or forearm.

    The Veri-Q plus Glucose Control Solutions are for use with the Veri-Q plus MGD-20(01 meter and the Veri-Q plus MGS-01 test strips to check that the meter and test strips are working together properly and providing accurate results.

    Device Description

    The proposed Veri-Q self testing/ plus MGD-2001 Blood Glucose Monitoring System consists of a meter, test strips, control solutions (3 levels), a lancing device and sterile lancets. The blood glucose test system is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood sample by means of an electrical current produced in the test strip and sent to the meter for measurement. The Veri-Q testing/plus MGD-2001 meter is a no-code meter, so the responsibility of coding has been removed from the user. Each individual test strip contains technology that allows it to automatically calibrate and code the meter once it is inserted.

    AI/ML Overview

    Here's an analysis of the acceptance criteria and supporting study for the Veri-Q self-testing/plus MGD-2001 Blood Glucose Monitoring System, based on the provided 510(k) summary:

    The 510(k) summary states that "The testing for the Veri-Q self-testing/plus MGD-2001 Blood Glucose Monitoring System was performed in accordance with ISO 15197:2003." This standard specifies requirements for blood-glucose monitoring systems for self-testing and includes acceptance criteria for analytical performance. However, the exact acceptance criteria and reported device performance values are not explicitly stated in the provided text. To fulfill the request comprehensively, one would typically need to refer directly to ISO 15197:2003 and the full study report submitted with the 510(k). Since that detailed information is not available in the provided text, I will describe the kind of acceptance criteria typically found in ISO 15197:2003 and note the absence of specific reported performance.

    A. Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Typical ISO 15197:2003)Reported Device Performance (from provided text)
    For glucose concentrations < 4.2 mmol/L (75 mg/dL):Not explicitly detailed.
    - At least 95% of results shall fall within ±0.83 mmol/L (±15 mg/dL) of the reference method.The document states, "The device passed all of the tests based on pre-determined Pass/Fail criteria."
    For glucose concentrations ≥ 4.2 mmol/L (75 mg/dL):Not explicitly detailed.
    - At least 95% of results shall fall within ±20% of the reference method.This implies the device met the ISO 15197:2003 criteria.
    Combined Criteria (Overall Accuracy):Not explicitly detailed.
    - At least 95% of all measured glucose values shall fall within the respective ranges specified above.
    - Also typically includes requirements for precision (repeatability and intermediate precision), linearity, effects of interfering substances, and user performance.

    B. Sample Size and Data Provenance for the Test Set

    • Sample Size: The provided 510(k) summary does not specify the exact sample size used for the performance testing. It only states that "Clinical evaluation included method comparison, user performance and alternative-site blood glucose measurement."
    • Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective.

    C. Number of Experts and Qualifications for Ground Truth

    • The document does not provide information on the number of experts used or their qualifications for establishing ground truth. For blood glucose monitoring systems, ground truth is typically established using a highly accurate laboratory reference method (e.g., YSI analyzer) operated by trained laboratory professionals, rather than "experts" in the traditional sense of medical specialists reviewing images or clinical cases.

    D. Adjudication Method for the Test Set

    • Adjudication methods (e.g., 2+1, 3+1) are typically used when multiple human readers or experts are involved in reviewing specific outputs or making diagnoses. This is not applicable to the type of performance study (analytical accuracy against a reference method) described for a blood glucose monitoring system. Therefore, no adjudication method would be listed.

    E. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    • Was it done? No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for imaging devices or algorithms that directly assist human interpretation in diagnostic tasks where human variability is a key factor. A blood glucose monitoring system directly measures a physiological parameter.
    • Effect Size: Not applicable.

    F. Standalone Performance Study

    • Was it done? Yes, a standalone performance study was done. The "Performance Data" section states, "Clinical evaluation included method comparison, user performance and alternative-site blood glucose measurement. Non-clinical performance evaluations were conducted to establish the performance, functionality and reliability characteristics of the Veri-Q self-testing/plus MGD-2001 Blood Glucose Monitoring System." This describes evaluating the device's accuracy and performance independently.

    G. Type of Ground Truth Used

    • The type of ground truth implied by performing testing "in accordance with ISO 15197:2003" and conducting "method comparison" is a highly accurate laboratory reference method for glucose measurement (e.g., a YSI Glucose Analyzer). The study compares the device's measurements to these reference values.

    H. Sample Size for the Training Set

    • The document does not provide information on the sample size for a "training set." Blood glucose monitoring systems typically do not rely on machine learning models that require a distinct "training set" in the same way AI algorithms for image analysis do. Their development relies on engineering, chemical processes, and calibration against reference standards, rather than supervised learning from large datasets.

    I. How Ground Truth for the Training Set Was Established

    • Not applicable, as a "training set" for a machine learning model is not relevant for this type of device. The accuracy of the device's fundamental measurement mechanism and calibration would be established against highly accurate laboratory reference methods as described in G.
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