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    K Number
    K021229
    Device Name
    MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244
    Manufacturer
    BECKMAN COULTER, INC.
    Date Cleared
    2002-06-28

    (71 days)

    Product Code
    DDR
    Regulation Number
    866.5680
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K000196
    Why did this record match?
    Device Name :

    MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244

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

    The Access Myoglobin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac Myoglobin levels in human serum and plasma using the Access Immunoassay Systems.
    Measurement of myoglobin aids in the rapid diagnosis of heart and renal disease.

    Device Description

    The Myoglobin reagents. Myoglobin calibrators, the Access Access Immunoassay Analyzer and the Access 2 Immunoassay Analyzer comprise the Access Immunoassay Systems for the quantitative determination of cardiac Myoglobin in human serum and plasma.

    AI/ML Overview

    The document provided describes the Access Myoglobin assay. Here's a breakdown of the acceptance criteria and study details:

    1. Table of Acceptance Criteria and Reported Device Performance:

    ParameterAcceptance Criteria (Implied)Reported Device Performance
    PrecisionConsistent and reproducible results (low %CV)- Within-run imprecision: 1.58%CV to 2.20%CV
    • Between-run imprecision: 2.34%CV to 4.24%CV
    • Total imprecision: 3.03%CV to 4.54%CV |
      | Analytical Sensitivity | Ability to detect low levels of Myoglobin (distinguishable from zero) | The lowest detectable level of Myoglobin distinguishable from zero (with 95% confidence) is
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