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    K Number
    K991242
    Device Name
    GLUCOMETER ELITE TEST STRIPS
    Manufacturer
    BAYER CORP.
    Date Cleared
    1999-06-30

    (79 days)

    Product Code
    CGA
    Regulation Number
    862.1345
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    GLUCOMETER ELITE TEST STRIPS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The GLUCOMETER ELITE® Test Strips are used with the GLUCOMETER ELITE® XL Blood Glucose Meter and the GLUCOMETER ELITE® Blood Glucose Test Systems to measure the glucose level in whole blood. The GLUCOMETER ELITE® XL and GLUCOMETER ELITE® Blood Glucose Systems are home-use (OTC) devices used by persons with diabetes, and by healthcare professionals in clinical settings for the self-monitoring of blood glucose and as an adjunct to the care of persons with diabetes.

    Device Description

    The GLUCOMETER ELITE® Test Strips (Modified) are for use with the GLUCOMETER ELITE® family of blood glucose meters. The GLUCOMETER ELITE® Blood Glucose Test System is an over-the-counter (OTC) home test for glucose in blood. The system is used by persons with diabetes and by healthcare professionals in home settings and in healthcare facilities.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and study for the GLUCOMETER ELITE® Test Strips.

    Based on the document, the device is not an AI/ML device, therefore, many of the typical acceptance criteria and study design elements found in AI/ML device approval are not applicable. The device is a blood glucose test strip, a traditional in-vitro diagnostic.

    However, I will extract the relevant information concerning performance and testing for this type of device.

    1. A table of acceptance criteria and the reported device performance

    Acceptance Criteria (Implicit)Reported Device Performance
    Suitable for intended use with 2 µL blood sample (primary change from predicate)"The studies indicate that the GLUCOMETER ELITE® Test Strips with the reduced volume are suitable for their intended use." and "The results of the evaluation of the GLUCOMETER ELITE® Test Strips (Modified) demonstrate satisfactory performance with 2 uL of specimen and are suitable for their intended use."
    Specificity for glucose"The GLUCOMETER ELITE® Blood Glucose Test Systems are specific for glucose..."
    Plasma/serum equivalent glucose results"...and have been referenced to give plasma/serum equivalent glucose results."
    Quantitative measurement of glucose in whole blood range"These test systems provide a quantitative measurement of glucose in whole blood from 20 - 600 mg/dL (1.1 to 33.3 mmol/L)."

    2. Sample size used for the test set and the data provenance

    • Sample Size for Test Set: Not explicitly stated. The document mentions "An in-house evaluation of the performance..." and "The studies indicate...", but no specific number of samples or subjects is provided for the test set.
    • Data Provenance: The study was "in-house," suggesting it was conducted by the manufacturer, Bayer Corporation. The country of origin of the data is not specified, but the manufacturer is listed as based in Elkhart, IN, USA, and the strips are manufactured in Kyoto, Japan. Given the "in-house" nature, it's likely a prospective evaluation specifically designed to test the modified strips.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

    • Not Applicable. This device is an in-vitro diagnostic for measuring a biochemical marker (glucose), not an imaging or diagnostic AI/ML system requiring expert interpretation for ground truth. Ground truth for blood glucose measurements is established through a reference laboratory method.

    4. Adjudication method for the test set

    • Not Applicable. As noted above, this is not an AI/ML device requiring expert adjudication. Performance here refers to the device's accuracy and precision against a reference method.

    5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

    • Not Applicable. This is not an AI/ML device, and there are no "human readers" in the context of interpreting results from this test strip. Its purpose is to provide a quantitative measurement of glucose.

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

    • Partially Applicable / Standalone (Device Only): The performance assessment was on the "GLUCOMETER ELITE® Test Strips (Modified)," which essentially is the standalone performance of the test strip and meter system. There is no human interpretation component in producing the numerical glucose reading. The study evaluates the device's ability to accurately measure glucose without human intervention influencing the measurement itself.

    7. The type of ground truth used

    • Reference Method: While not explicitly stated in the provided text, for blood glucose measurement devices, ground truth is typically established using a highly accurate and precise laboratory reference method (e.g., hexokinase method) on the same blood samples. The document states the system "have been referenced to give plasma/serum equivalent glucose results," implying comparison to such a reference.

    8. The sample size for the training set

    • Not Applicable. This is not an AI/ML device that requires a "training set." The strips are based on a chemical reaction (Glucose Oxidase method) and electrical potential measurement, not a learned algorithm.

    9. How the ground truth for the training set was established

    • Not Applicable. As there is no training set for this type of device, this question is not relevant.
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