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510(k) Data Aggregation

    K Number
    K101911
    Device Name
    IMMUKNOW-THE CYLEX IMMUNE CELLFUNCTION ASSAY
    Manufacturer
    Date Cleared
    2010-10-18

    (101 days)

    Product Code
    Regulation Number
    864.5220
    Why did this record match?
    Applicant Name (Manufacturer) :

    CYLEX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ImmuKnow®-the Cylex®™Immune Cell Function Assay measures the concentration of ATP from circulating CD4 cells following in vitro stimulation with phytohemagglutinin (PHA) as an indicator of immune cell function. This measurement is made on heparin anti-coagulated whole blood using a luminometer and luciferin/luciferase. The assay is used for the detection of cell mediated immune response in populations undergoing immunosuppressive therapy for organ transplant.
    Device Description
    The Cylex Immune Cell Function Assay measures the concentration of ATP from circulating CD4 cells following in vitro stimulation with phytohemagglutinin (PHA) as an indicator of immune cell function. This measurement is made on heparin anti-coagulated whole blood using a luminometer and luciferin/luciferase. The assay is used for the detection of cell mediated immune response in populations undergoing immunosuppressive therapy for organ transplant. Test Description The Cylex Immune Cell Function Assay detects cell-mediated immunity in whole blood after a 15-18 hour incubation with stimulant. During incubation, increased ATP synthesis occurs within the cells that respond to the stimulant phytohemagglutinin (PHA). Concurrently, whole blood is incubated in the absence of stimulant for the purpose of assessing basal ATP activity. Anti-CD4 monoclonal antibody coated magnetic particles are added to immunoselect CD4 cells from both the stimulated and non-stimulated wells. After washing the selected CD4 cells on a magnet tray, Lysis Reagent is added to release intracellular ATP. Addition of Luminescence Reagent (luciferin/luciferase) to the released ATP produces light according to the following equation: Mg24 Luciferin +ATP +O2 Luciferase Oxyluciferin +AMP +Pyrophosphate +CO2 + Light The amount of light measured by a luminometer (emission maximum 562 nm) is proportional to the concentration of ATP. The concentration of ATP (ng/mL) is calculated from a calibration curve and compared to ATP level ranges to characterize the cellular immune function of the sample.
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    K Number
    K013169
    Device Name
    IMMUNE CELL FUNCTION ASSAY
    Manufacturer
    Date Cleared
    2002-04-02

    (193 days)

    Product Code
    Regulation Number
    864.5220
    Why did this record match?
    Applicant Name (Manufacturer) :

    CYLEX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Cylex Immune Cell Function Assay measures the concentration of ATP from circulating CD4 cells following in vitro stimulation with phytohemagglutinin (PHA) as an indicator of immune cell function. This measurement is made on heparin anticoagulated whole blood using a luminometer and luciferin/luciferase. The assay is used for the detection of cell mediated immune response in populations undergoing immunosuppressive therapy for organ transplant. The Cylex Immune Cell Function Assay detects cell-mediated immunity (CMI) by measuring the concentration of ATP from CD4 cells following stimulation. This measurement is made on heparin anti-coagulated whole blood using a luminometer and luciferin/luciferase. The assay is used for the detection of cell-mediated immunity in an immunosuppressed population.
    Device Description
    The Cylex Immune Cell Function Assay measures the concentration of ATP following in vitro stimulation with phytohemagglutinin (PHA) as an indicator of immune cell function. This measurement is made on heparin anti-coagulated whole blood using a luminometer and luciferin/luciferase. The assay is used for the detection of cell mediated immune response in populations undergoing immunosuppressive therapy for organ transplant. The Cylex Immune Cell Function Assay detects cell-mediated immunity in whole blood. Following incubation, increased ATP synthesis occurs within the cells that respond to the stimulant phytohemagglutinin (PHA). Concurrently, whole blood to monoclonal antibody coated magnetic particles are added to immunoselect CD4 cells from both the stimulated and non-stimulated wells. After washing the selected CD4 cells on a magnet tray, Lysis Reagent is added to release intracellular ATP. Through the released ATP produces light according to the following equation: Luciferin + ATP + O2 Luciferase Mo Oxyluciferin + AMP + Pyrophosphate + CO2 + Light. The amount of light measured by a luminometer (emission maximum 562 nm) is proportional to the concentration of ATP. The concentration of ATP (ng/mL) is calculated from a calibration curve to characterize the cellular immune function of the sample.
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