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510(k) Data Aggregation

    K Number
    K080404
    Device Name
    EASYQC - CHEMISTRY WITH ELECTROLYTES; CHEMISTRY; ELECTROLYTES KIT; CHEMISTRY CALIBRATOR, CREA-U CLAIBRATOR
    Manufacturer
    MEDICA CORP.
    Date Cleared
    2009-03-13

    (393 days)

    Product Code
    JIX,JIT,JJR,JJY
    Regulation Number
    862.1150
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EASYQC - CHEMISTRY WITH ELECTROLYTES; CHEMISTRY; ELECTROLYTES KIT; CHEMISTRY CALIBRATOR, CREA-U CLAIBRATOR

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

    MEDICA's EasyQC - Chemistry, Levels A and B, is a quality control material for clinical chemistry intended for use in the MEDICA EasyRA Chemistry Analyzer to estimate test precision and to detect any potential systemic analytical deviations.

    MEDICA's EasyElectroLytes kit is a quality control material for clinical chemistry intended for use in the MEDICA EasyRA Chemistry Analyzer to estimate test precision and to detect any potential systemic analytical deviations.

    MEDICA's EasyQC - Chemistry and Electrolytes, Levels A and B is a quality control material for clinical chemistry intended for use in the MEDICA EasyRA Chemistry Analyzer to estimate test precision and to detect any potential systemic analytical deviations.

    MEDICA's EasyCal - Multiconstituent Calibrator is intended for use in the MEDICA EasyRA Chemistry Analyzer to establish points of reference in the measurement of a number of analytes in human serum.

    MEDICA CREA-U Cal is intended for use in the MEDICA EasyRA Chemistry Analyzer to establish points of reference in the measurement of Creatinine in urine.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification approval by the FDA for Medica Corporation's quality control materials and calibrators for clinical chemistry. It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of AI/ML or diagnostic performance. Instead, it confirms that the devices are substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot provide the requested information based on the given text. The document focuses on regulatory approval rather than a detailed technical performance study with acceptance criteria.

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