LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K123007
    Device Name
    VERI-Q MGD-1001 BLOOD GLUCOSE MONITORING SYSTEM, VERI-Q PLUS MGD-1001 BLOOD GLUCOSE MONITORING SYSTEM
    Manufacturer
    MICOBIOMED CO, LTD
    Date Cleared
    2013-06-19

    (265 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-1001 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-1001 Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. The Veri-Q self-testing MGD-1001 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 self-testing MGD-1001 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-1001 meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from fingertips. palm. or forcarm.

    The Veri-Q self-testing Glucose Control Solutions are for use with the Veri-Q self-testing MGD-1001 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-1001 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-1001 Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use). The Veri-Q plus MGD-1001 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-Q plus MGD-1001 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 plus MGS-01 test strips are for use with the Veri-Q plus MGD-1001 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-1001 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-1001 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 The orded gracess 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 self-testing / plus MGD-1001 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 a breakdown of the acceptance criteria and study information for the Veri-Q self-testing / plus MGD-1001 Blood Glucose Monitoring System, based on the provided 510(k) summary:

    1. Table of Acceptance Criteria and Reported Device Performance

    The 510(k) summary states that the device was tested in accordance with ISO 15197:2003. This standard defines the acceptance criteria for blood glucose monitoring systems. However, the specific numerical acceptance criteria and the detailed reported performance results are not explicitly provided in the given text. The summary only generally states:

    "The device passed all of the tests based on pre-determined Pass/Fail criteria."

    To accurately complete this table, one would need to refer to the full ISO 15197:2003 standard and the detailed performance report submitted for the 510(k). As a general reference for ISO 15197:2003, common criteria include:

    Acceptance Criteria (Based on ISO 15197:2003, typical)Reported Device Performance (Not specified in provided text)
    System Accuracy (within ±15% or ±0.83 mmol/L):
    - For glucose concentrations < 4.2 mmol/L (75 mg/dL)(e.g., X% of results within ±0.83 mmol/L of reference)
    - For glucose concentrations ≥ 4.2 mmol/L (75 mg/dL)(e.g., Y% of results within ±15% of reference)
    Repeatability/Precision:
    - Coefficient of Variation (CV) for various glucose(e.g., CV at low, mid, high concentrations)
    levels
    Intermediate Precision:
    - CV across multiple days, operators, etc.(e.g., CV at low, mid, high concentrations)
    Linearity:(e.g., demonstrates linearity across measuring range)
    Interferences (e.g., hematocrit, common substances):(e.g., no significant interference from tested substances)
    Usability/Human Factors:(e.g., passed usability studies)

    2. Sample Size Used for the Test Set and Data Provenance

    • Sample Size for Test Set: Not explicitly stated in the provided 510(k) summary. The summary mentions "Clinical evaluation" and "Non-clinical testing" but does not give the number of samples or subjects.
    • Data Provenance: Not specified. The submitter is MiCoBioMed Co., Ltd. from Republic of Korea, but there is no information about the country of origin of the data or whether it was retrospective or prospective.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

    • Number of Experts: This is a blood glucose monitoring system. Ground truth for blood glucose is typically established using a laboratory reference method (e.g., hexokinase, glucose oxidase method on a high-precision analyzer), not by human experts. Therefore, the concept of "experts establishing ground truth" as it applies to image analysis or diagnostic interpretation by radiologists is not applicable here.
    • Qualifications of Experts: N/A (as explained above).

    4. Adjudication Method for the Test Set

    • Adjudication Method: Not applicable. For blood glucose meters, the reference method provides the "ground truth," and there is no human adjudication process involved in comparing meter readings to expert consensus.

    5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

    • MRMC Study: No. This type of study (MRMC) is typically relevant for diagnostic imaging devices where human readers interpret cases. For a blood glucose monitoring system, the performance is assessed against a laboratory reference method, and improvement in human reader performance is not a relevant metric.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

    • Standalone Performance: For a blood glucose meter, the "standalone performance" is essentially the system accuracy and precision testing conducted. The device (meter and test strip) acts as the algorithm, providing a quantitative measurement. The clinical evaluation mentioned in the summary, which includes "method performance," falls under this category. The results are compared directly to a laboratory reference method.

    7. The Type of Ground Truth Used

    • Type of Ground Truth: The ground truth for blood glucose monitoring systems is established using a laboratory reference method (e.g., YSI analyzer, hexokinase method). This method is considered the highly accurate standard against which the performance of the point-of-care device is measured.

    8. The Sample Size for the Training Set

    • Sample Size for Training Set: Not applicable/Not specified. Blood glucose monitoring systems are generally designed and calibrated during their development (internal "training") using a set of known glucose concentrations. The 510(k) summary does not mention a separate "training set" in the context of machine learning, as this is not an AI/ML-based diagnostic imaging or pattern recognition device. The "training" would be part of the manufacturing calibration process.

    9. How the Ground Truth for the Training Set was Established

    • How Ground Truth for Training Set was Established: Not applicable/Not specified. As with the test set, during the development and calibration of the device, known glucose concentrations (prepared using highly accurate reference substances or measured by laboratory reference methods) would be used to calibrate the meter and test strips. This is an engineering calibration process, not "ground truth establishment" in the AI/ML sense.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1