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510(k) Data Aggregation

    K Number
    K193475
    Device Name
    OneTouch Verio Reflect Blood Glucose Monitoring System
    Manufacturer
    LifeScan Europe GmbH
    Date Cleared
    2020-02-14

    (60 days)

    Product Code
    NBW
    Regulation Number
    862.1345
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K150214
    Predicate For
    K240640
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The OneTouch Verio Reflect Blood Glucose Monitoring System is composed of the OneTouch Verio Reflect Meter and OneTouch Verio Test Strips. The OneTouch Verio Reflect Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The OneTouch Verio Reflect Blood Glucose Monitoring System is intended for self-testing outside the body (in-vitro diagnostic use), by individuals with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended to be used by a single person and should not be shared. The system should not be used for the diagnosis of, or screening for diabetes or for neonatal use.

    Device Description

    The OneTouch Verio Reflect Blood Glucose Monitoring System consists of the OneTouch Verio Reflect Blood Glucose Meter, OneTouch Verio Test Strips, OneTouch Verio Level 3 and Level 4 Control Solutions, Lancing Device and Sterile Lancets. The OneTouch Verio Reflect Blood Glucose Monitoring System measures the glucose content of a blood sample by means of an electrical current produced in the test strip and sent to the meter for measurement. The OneTouch Verio Reflect meter also contains tools to aid diabetes management which include a dynamic range indicator, test tracker, blood sugar mentor, trend90 average blood glucose and meal and advanced tagging.

    AI/ML Overview

    The OneTouch Verio Reflect Blood Glucose Monitoring System was evaluated for its accuracy in a Lay User Method Comparison Study. The study assessed the device's performance against a laboratory reference method, the Yellow Springs Instrument (YSI 2300 STAT PLUS glucose analyzer).

    1. Acceptance Criteria and Reported Device Performance:

    Acceptance Criteria (from FDA Guidance: Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use (October 2016))Reported Device Performance (OneTouch Verio Reflect Blood Glucose Monitoring System)
    For glucose concentrations ≥ 75 mg/dL: At least 95% of results must be within ±15% of the reference method.99.2% of results were within ±15% of the YSI 2300 reference instrument.
    For glucose concentrations < 75 mg/dL: At least 95% of results must be within ±15 mg/dL of the reference method.No specific detailed breakdown for concentrations < 75 mg/dL provided in the summary table, but the overall 99.2% within ±15% performance suggests this criterion was met.

    2. Sample Size and Data Provenance:

    • Sample Size for Test Set: 354 lay persons (fingertip capillary blood samples).
    • Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's a "Lay User Method Comparison Study" conducted for regulatory submission, it is highly likely to be a prospective study.

    3. Number of Experts and Qualifications for Ground Truth:

    Not applicable in this context. The ground truth for glucose concentration was established by a laboratory reference instrument (YSI 2300 STAT PLUS glucose analyzer), not human expert interpretation.

    4. Adjudication Method:

    Not applicable. The ground truth was established by a laboratory instrument, not human review requiring adjudication.

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

    Not applicable. This device is a blood glucose monitoring system, and its performance is assessed against a laboratory reference standard, not through a comparative study with human readers (with or without AI assistance).

    6. Standalone (Algorithm Only) Performance:

    The reported performance is the standalone performance of the device as used by lay users, essentially the algorithm's performance in determining glucose levels from the test strip sample. No "human-in-the-loop" was involved in the measurement process for the reported accuracy.

    7. Type of Ground Truth Used:

    Instrument-based reference measurement: Yellow Springs Instrument (YSI 2300 STAT PLUS glucose analyzer).

    8. Sample Size for Training Set:

    The document does not explicitly mention a "training set" in the context of machine learning or AI algorithms as would typically be described for image analysis devices. The "blood glucose algorithm" mentioned is likely part of the device's core operating principle, which would be developed and validated through extensive R&D and analytical studies rather than a distinct training set for a machine learning model.

    9. How Ground Truth for Training Set was Established:

    Not explicitly stated regarding a distinct "training set" as commonly understood in AI/ML. The device's underlying algorithm development would have relied on a combination of chemical principles, laboratory measurements, and potentially large datasets of glucose readings and interfering substances to refine its accuracy and interference reduction capabilities.

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