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    K Number
    K013373
    Device Name
    OMNI C ANALYZER
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Date Cleared
    2001-11-02

    (22 days)

    Product Code
    CEM,CGZ,CHL,GKF,GKR,GLY,JFP,JGS
    Regulation Number
    862.1600
    Type
    Special
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K990092
    Why did this record match?
    Device Name :

    OMNI C ANALYZER

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

    The Roche Diagnostics Omni C Analyzer is intended to be used for the measurement of pH, PO2, PCO2, sodium, potassium, ionized calcium, chloride, hematocrit, total hemoglobin and oxygen saturation in samples of whole blood, serum, plasma and aqueous solutions as appropriate.

    Device Description

    The Omni C analyzer represents a combined blood gas, electrolyte, total hemoglobin, hematocrit and oxygen saturation test system classified as a Class II device under various sections of 21 CFR 862 and 864 based on the individual test parameters measured.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary for the Omni C Analyzer, focusing on its substantial equivalence to a predicate device. It describes the device's intended use, its similarities and differences to the predicate, and lists the regulatory classifications, but it does not include details on performance studies, sample sizes, expert involvement, or ground truth establishment.

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