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    K Number
    K092737
    Device Name
    EASYRA MG REAGENT, MODEL 10220
    Manufacturer
    MEDICA CORP.
    Date Cleared
    2009-11-17

    (70 days)

    Product Code
    JGJ
    Regulation Number
    862.1495
    Type
    Special
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EASYRA MG REAGENT, MODEL 10220

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

    The EasyRA Magnesium Reagent is for the in-vitro quantitative measurement of magnesium in serum on the Medica EasyRA analyzer. Magnesium measurements are used in the diagnosis and treatment of: Hypermagnesemia occuring during renal failure, acute diabetic acidosis, dehydration or in Addison's disease. Hypomagnesemia observed in cases of chronic alcoholism, malabsorption, acute pancreatitis and kidney disorders. For in vitro diagnostic use only.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called "Magnesium EasyRA Reagent." It indicates that the device has been found substantially equivalent to a legally marketed predicate device. The information provided is primarily regulatory in nature and does not contain details about specific acceptance criteria or a study proving the device meets them.

    Therefore, I cannot provide the requested information based on the provided text. The document states the device name, intended use, and regulatory classification but lacks specific performance metrics, study designs, sample sizes, or ground truth establishment relevant to the questions asked.

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