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510(k) Data Aggregation

    K Number
    K131136
    Device Name
    GLUCOSE METER-CHECK SOLUTION FOR TAIDOC
    Manufacturer
    BIONOSTICS, INC.
    Date Cleared
    2013-05-31

    (39 days)

    Product Code
    JJX
    Regulation Number
    862.1660
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K093724
    Why did this record match?
    Device Name :

    GLUCOSE METER-CHECK SOLUTION FOR TAIDOC

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

    Glucose Meter-Check Solution for TaiDoc is intended for in vitro diagnostic use (i.e., for external use only) to assess the performance of blood glucose meters and test strips manufactured by TaiDoc Technology Corporation by healthcare professionals and in the home by people with diabetes mellitus. For In Vitro Diagnostic Use

    Device Description

    The control solutions are comprised of buffered aqueous liquid glucose control solution with viscosity modifiers to simulate certain properties of blood on the test strip and colored red to help users see the solution while dispensing onto a test strip. The control solutions are formulated to have performance comparable to those currently manufactured by TaiDoc Technology Corporation. The product is packaged in plastic bottles with dropper tips for dispensing the control solutions for use with test strips. This is a non-hazardous aqueous glucose control solution containing no ingredients of biological origin, or in concentrations qualifying as a controlled product under the Controlled Products Regulation.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study details for the Glucose Meter-Check® Solution for TaiDoc, based on the provided 510(k) summary:

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria for the Glucose Meter-Check Solution are derived from its intended use as a quality control material to assess the performance of TaiDoc blood glucose meters and test strips. The "performance" in this context refers to its ability to consistently produce glucose measurements within specified target ranges when tested on the intended meters and strips.

    Characteristic / Acceptance CriteriaReported Device Performance
    Traceability of Glucose ConcentrationConfirmed utilizing YSI-supplied calibrators traceable to NIST SRM 917.
    Closed Bottle Stability (un-opened shelf-life)2 years (24 months) at 15°C to 30°C (59°F to 86°F), as measured by YSI 2300 calibrated with N.I.S.T. 917 traceable materials.
    Stability After Opening (percent glucose recovery)Less than 5% change in percent glucose recovery on YSI from a single lot evaluated over 3 months (93 days in real time) when stored at ambient temperature (21-23 °C / 70-75 °F) compared to refrigerated vials (2-8 °C).
    Value Assignment Range (for each lot and level)Mean of all measurements ± 15 mg/dL (if glucose
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