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510(k) Data Aggregation

    K Number
    K110675
    Device Name
    EASYRA UREA NITROGEN AND CREATININE REAGENTS
    Manufacturer
    MEDICA CORP.
    Date Cleared
    2011-04-21

    (42 days)

    Product Code
    CDQ,CGX
    Regulation Number
    862.1770
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EASYRA UREA NITROGEN AND CREATININE REAGENTS

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

    EasyRA BUN Reagent: The EasyRA Urea Nitrogen (BUN) Reagent is for the measurement of urea nitrogen in serum and plasma using the "EasyRA chemistry analyzer". Urea measurements are used for the diagnosis and treatment of certain renal and metabolic diseases. For in vitro diagnostic use only. EasyRA CREA Reagent: The EasyRA Creatinine (CREA) Reagent is for the measurement of Creatinine in serum and plasma using the "EasyRA chemistry analyzer". Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis. 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 medical device. Therefore, the requested information about acceptance criteria, study design for AI performance, sample sizes, expert ground truth, adjudication methods, and MRMC studies is not applicable to this document. The document primarily focuses on establishing substantial equivalence for the EasyRA BUN Reagent and EasyRA CREA Reagent to predicate devices.

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