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510(k) Data Aggregation

    K Number
    DEN130005
    Device Name
    QUANTITATION OF ORGANOPHOSPHATE METABOLITES IN URINE BY LC/MS/MS
    Date Cleared
    2013-08-08

    (72 days)

    Product Code
    Regulation Number
    862.3652
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    Product Code :

    PDY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This device is intended for the quantitation of specific organophosphate metabolites by LC/MS/MS. The device system includes organophosphate metabolite calibrators to calibrate the system and organophosphate metabolite controls for quality control monitoring of the system. This device is intended for use in a single laboratory to detect and measure the concentration of specific organophosphate metabolites in human urine from individuals who have signs and symptoms consistent with cholinesterase poisoning. The data obtained by this device will be used following an exposure or suspected exposure event to confirm exposure, identify the causative agent, and distinguish exposed from the unexposed patients.
    Device Description
    The device comprises internal standards which serve as the basis for the calibrators and quality control materials. A solid phase extraction cartridge is initially used to extract the metabolites for further separation and analysis on a tandem mass spectrometer and HPLC system.
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