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510(k) Data Aggregation
K Number
K101911Device Name
IMMUKNOW-THE CYLEX IMMUNE CELLFUNCTION ASSAY
Manufacturer
Date Cleared
2010-10-18
(101 days)
Product Code
Regulation Number
864.5220Why 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
K013169Device Name
IMMUNE CELL FUNCTION ASSAY
Manufacturer
Date Cleared
2002-04-02
(193 days)
Product Code
Regulation Number
864.5220Why 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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