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510(k) Data Aggregation

    K Number
    K123802
    Device Name
    EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT
    Manufacturer
    MEDICA CORP.
    Date Cleared
    2013-03-01

    (81 days)

    Product Code
    CIG
    Regulation Number
    862.1110
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT

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

    The EasyRA TBIL reagent is intended for the quantitative measurement of Total Bilirubin in human serum and plasma of adults on the Medica EasyRA analyzer in clinical laboratories. Bilirubin measurements are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block. For in vitro diagnostic use only.

    The EasyRA DBIL reagent is intended for the quantitative measurement of Direct Bilirubin in human serum and plasma of adults on the Medica EasyRA analyzer in clinical laboratories. Bilirubin measurements are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block. For in vitro diagnostic use only.

    The EasyRA CK reagent is intended for the quantitative determination of Creatine Kinase (CK) in human serum and plasma, using the MEDICA "EasyRA Chemistry analyzer" in clinical laboratories. Measurements of CK are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. For in vitro diagnostic use only.

    Device Description

    Not Found

    AI/ML Overview

    This is a 510(k) premarket notification for in-vitro diagnostic reagents, not an AI/ML device. Therefore, the requested information about acceptance criteria, study design, and ground truth for an AI/ML device is not applicable here.

    The document discusses the substantial equivalence of the EasyRA Total Bilirubin Reagent, EasyRA Direct Bilirubin Reagent, and EasyRA Creatinine Kinase Reagent to legally marketed predicate devices. The review is focused on the regulatory classification and general controls provisions for these diagnostic reagents.

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