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510(k) Data Aggregation

    K Number
    K040974
    Device Name
    GLUCOSE OXIDASE, GLUCOSE
    Manufacturer
    GENCHEM, INC.
    Date Cleared
    2004-12-27

    (257 days)

    Product Code
    CGA
    Regulation Number
    862.1345
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K761060
    Why did this record match?
    Device Name :

    GLUCOSE OXIDASE, GLUCOSE

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

    The GenChem Glucose Oxidase Reagent is for the quantitative determination of glucose in serum, plasma, urine and cerebrospinal fluid on the Beckman SYNCHRON CX3® System to aid in the diagnosis of diabetes, liver disease and certain endocrine disorders.

    Device Description

    The Device is a solution containing sufficient Glucose Oxidase, surfactants and other ingredients necessary for optimum system operation on the Beckman CX3® Analyzer.

    AI/ML Overview

    This submission pertains to the GenChem Glucose Oxidase Reagent for the quantitative determination of glucose. The study evaluates the device's performance against predefined criteria across various metrics.

    1. Table of Acceptance Criteria and Reported Device Performance

    Performance CharacteristicAcceptance Criteria (Implicit)Reported Device Performance
    Precision/Reproducibility
    Serum Glucose (60mg/dL)Low %CV for within-run and total imprecisionWithin Run: 1.4%CV; Total: 2.1%CV
    Serum Glucose (220mg/dL)Low %CV for within-run and total imprecisionWithin Run: 0.6%CV; Total: 1.1%CV
    Serum Glucose (387mg/dL)Low %CV for within-run and total imprecisionWithin Run: 0.6%CV; Total: 1.3%CV
    CSF Glucose (57mg/dL)Low %CV for within-run and total imprecisionWithin Run: 1.2%CV; Total: 2.4%CV
    CSF Glucose (33mg/dL)Low %CV for within-run and total imprecisionWithin Run: 1.9%CV; Total: 4.1%CV
    Urine Glucose (24mg/dL)Low %CV for within-run and total imprecisionWithin Run: 2.9%CV; Total: 5.8%CV
    Urine Glucose (315mg/dL)Low %CV for within-run and total imprecisionWithin Run: 1.0%CV; Total: 1.6%CV
    ORDAC Serum Glucose (557mg/dL)Low %CV for within-run and total imprecisionWithin Run: 1.5%CV; Total: 1.8%CV
    ORDAC Serum Glucose (770mg/dL)Low %CV for within-run and total imprecisionWithin Run: 0.9%CV; Total: 1.5%CV
    Linearity/Assay Reportable RangeSlope close to 1, Intercept close to 0, high R-squaredSlope: 1.012, Intercept: 0.1.97, R²: 1.000
    Normal Range (All Specimens)Accurate detection within 5 to 450 mg/dL5 to 450 mg/dL (0.3 to 25 mmol/L)
    ORDAC Range (All Specimens)Accurate detection within 450 to 900 mg/dL450 to 900 mg/dL (25 to 50 mmol/L)
    SensitivityValue
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