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510(k) Data Aggregation

    K Number
    K093939

    Validate with FDA (Live)

    Device Name
    ADVIA CHEMISTRY SALICYLATE REAGENT
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Date Cleared
    2010-05-19

    (148 days)

    Product Code
    DKJ
    Regulation Number
    862.3830
    Type
    Traditional
    Panel
    Clinical Chemistry
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For in vitro diagnostic use in the quantitative determination of salicylate in human serum and plasma (lithium heparin) on the ADVIA 1650 Chemistry systems. Such measurements are used in the diagnosis of salicylate toxicity and overdose

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. The document is an FDA 510(k) clearance letter for the "ADVIA Chemistry Salicylate Reagent" and primarily discusses regulatory compliance and indications for use. No clinical study data or performance metrics are present in the provided pages.

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