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510(k) Data Aggregation

    K Number
    K070810
    Device Name
    ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F)
    Manufacturer
    BIOKIT S.A.
    Date Cleared
    2007-06-08

    (74 days)

    Product Code
    LGS, DLJ
    Regulation Number
    862.3880
    Why did this record match?
    Product Code :

    LGS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ARCHITECT i Theophylline assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of theophylline in human serum or plasma on the ARCHITECT i System with STAT protocol capability. Theophylline is used in the treatment of bronchospasm associated with bronchial asthma, chronic bronchitis and pulmonary emphysema. The measurements obtained are used in the diagnosis and treatment of theophylline overdose or in monitoring levels of theophylline to help ensure appropriate therapy. The ARCHITECT i Theophylline Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of theophylline in human serum and plasma.
    Device Description
    The ARCHITECT iTheophylline assay is a one-step STAT immunoassay for the quantitative determination of theophylline in human serum or plasma using CMIA technology, with flexible assay protocols, referred to as Chemiflex. Sample, anti-theophylline coated paramagnetic microparticles, and theophylline acridinium-labeled conjugate are combined to create a reaction mixture. The antitheophylline coated microparticles bind to theophylline present in the sample and to the theophylline acridinium-labeled conjugate. After washing, pre-trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). An indirect relationship exists between the amount of theophylline in the sample and the RLUs detected by the ARCHITECT / System optics.
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    K Number
    K955567
    Device Name
    INNOFLUOR THEOPHYLLINE ASSAY SYSTEM
    Manufacturer
    OXIS INTL., INC.
    Date Cleared
    1996-01-24

    (49 days)

    Product Code
    LGS
    Regulation Number
    862.3880
    Why did this record match?
    Product Code :

    LGS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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