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510(k) Data Aggregation

    K Number
    K173511
    Device Name
    ActiveCare TD-4121 Blood Glucose Monitoring System
    Manufacturer
    TaiDoc Technology Corporation
    Date Cleared
    2018-07-12

    (241 days)

    Product Code
    NBW
    Regulation Number
    862.1345
    Type
    Special
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K100322
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ActiveCare TD-4121 Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) in the quantitative measurement of glucose in fresh capillary whole blood taken from the finger. It is intended to be used by people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. The ActiveCare TD-4121 Blood Glucose Monitoring System is comprised of the ActiveCare TD-4121 glucose meter and the ActiveCare TD-4121 blood glucose test strip. The ActiveCare TD-4121 Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. The ActiveCare TD-4121 Blood Glucose Monitoring System is not intended for the diagnosis of, or screening of diabetes. It is not intended for use on neonates.

    Device Description

    The ActiveCare TD-4121 Blood Glucose Monitoring System is comprised of the ActiveCare TD-4121 glucose meter and the ActiveCare TD-4121 blood glucose test strip. They have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results. Use only ActiveCare TD-4121 blood glucose test strip with ActiveCare TD-4121 Blood Glucose Monitoring System.

    AI/ML Overview

    The document describes the ActiveCare TD-4121 Blood Glucose Monitoring System, an over-the-counter device intended for quantitative measurement of glucose in fresh capillary whole blood from the finger. It is used by people with diabetes mellitus at home to monitor their diabetes control program but is not for diagnosis or screening of diabetes, nor for use on neonates.

    The device's acceptance criteria are based on its performance compared to a predicate device (TD-4277 Blood Glucose Monitoring System) and its conformance to established accuracy standards for blood glucose meters.

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

    1. Table of Acceptance Criteria and Reported Device Performance:

    The document implicitly references ISO 15197 for accuracy standards, as is common for blood glucose monitoring systems. Although a specific table of acceptance criteria with numerical targets is not explicitly provided in the excerpt, the typical acceptance criteria for accuracy of blood glucose meters, as per ISO 15197:2013, are:

    Acceptance Criteria (typically ISO 15197:2013)Reported Device Performance (from the context of SE determination)
    Accuracy relative to laboratory reference method:Demonstrated to be accurate.
    - For glucose concentrations < 100 mg/dL:≥ 95% of results within ± 15 mg/dL
    - For glucose concentrations ≥ 100 mg/dL:≥ 95% of results within ± 15%
    - Overall, across the measuring range:≥ 99% of results within specific error boundaries (not detailed)
    Repeatability/Reproducibility:Not explicitly detailed in the provided text.
    User Performance (Lay User Study):Implied by "over-the-counter use" and "at home" indication.

    The document states under "Similarities" that the "Accuracy" of the ActiveCare TD-4121 Blood Glucose Monitoring System is similar to the predicate device (TD-4277 Blood Glucose Monitoring System). This implies that the device met the accuracy standards expected for the predicate, which would have been established during its 510(k) clearance (K100322). The "Conclusion" also states that the ActiveCare TD-4121 and TD-4277 systems are "substantially equivalent" based on the information provided, which includes meeting performance criteria.

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

    • Sample Size: Not explicitly stated. The document refers to "clinical and non-clinical studies" but does not give specific numbers of participants or samples.
    • Data Provenance: Not explicitly stated. However, the submitter is TaiDoc Technology Corporation, based in New Taipei City, Taiwan. It is reasonable to infer that the studies were conducted in Taiwan or by the manufacturer. The document does not specify if the studies were retrospective or prospective.

    3. Number of Experts Used to Establish Ground Truth and Qualifications:

    • Number of Experts: Not applicable. For blood glucose monitoring systems, ground truth is typically established by comparing device results to a highly accurate laboratory reference method, not by expert consensus on interpretations.
    • Qualifications of Experts: Not applicable in the traditional sense of clinical experts.

    4. Adjudication Method for the Test Set:

    • Not applicable. Adjudication methods like 2+1 or 3+1 are typically used when there's subjective interpretation by human readers (e.g., in diagnostic imaging). For quantitative measurements like blood glucose, the "ground truth" is determined by a reference device.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

    • No, an MRMC comparative effectiveness study was not done. This type of study (comparing human readers with and without AI assistance) is not relevant for a standalone blood glucose monitoring system, which does not involve human interpretation or AI assistance in this context.

    6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

    • Yes, a standalone performance study was implicitly done. The "clinical and non-clinical studies" mentioned involved comparing the device's measurements directly against a reference laboratory method (YSI-2300 Glucose Analyzer). This represents the performance of the device (meter and strip) as a standalone system, as it provides a quantitative measurement without human intervention for result interpretation beyond reading the display.

    7. Type of Ground Truth Used:

    • Laboratory Reference Method: The ground truth was established using the YSI-2300 Glucose Analyzer. The document explicitly states: "This system is compared to the YSI-2300 Glucose Analyzer in the clinical and non-clinical studies."

    8. Sample Size for the Training Set:

    • Not explicitly stated. The document describes a 510(k) submission for a device, not an AI/ML model, so the concept of a "training set" for an algorithm in the machine learning sense is not directly applicable here. The device's calibration and development would have involved internal testing and validation, but these are not typically referred to as "training sets" in the context of conventional medical devices.

    9. How the Ground Truth for the Training Set Was Established:

    • Not applicable in the machine learning "training set" sense. For the device itself, the accuracy and calibration would have been established against a reference method. The document mentions that "The YSI is calibrated with NIST (SRM) 917A reference material." This indicates that the primary reference method (YSI-2300) used for evaluating the device's accuracy is traceable to a recognized national standard, ensuring the reliability of the ground truth.
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