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510(k) Data Aggregation

    K Number
    K100684
    Device Name
    CELLTRACKS AUTOPREP SYSTEM MODEL:9541
    Manufacturer
    VERIDEX, LLC
    Date Cleared
    2010-08-26

    (169 days)

    Product Code
    GKH
    Regulation Number
    864.5240
    Why did this record match?
    Product Code :

    GKH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CellTracks® AutoPrep® System is a general purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole blood. Cell analyzers such as the CellTracks Analyzer II®, CellSpotter® System, flow cytometers or microscopes may be used for cell identification and enumeration. The system is for in vitro diagnostic use.
    Device Description
    The CellTracks® AutoPrep® System is a general purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole blood. The CellTracks® AutoPrep® System processes up to 8 samples in a batch, performing all required process steps, including red cell detection, plasma aspiration and final transfer to the analysis cartridge. The user is prompted to perform various pre-processing operations such as dilution and centrifugation. Cell analyzers such as the CellTracks Analyzer II®, CellSpotter® System, flow cytometers or microscopes may be used for cell identification and enumeration following processing. The AutoPrep® system uses a series of immunomagnetic separation procedures to isolate the cells of interest and to stain the cells with fluorescence-labeled monoclonal antibodies.
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    K Number
    K040077
    Device Name
    IMMUNICON CELLTRACKS AUTOPREP SYSTEM
    Manufacturer
    IMMUNICON CORP.
    Date Cleared
    2004-03-12

    (58 days)

    Product Code
    GKH
    Regulation Number
    864.5240
    Why did this record match?
    Product Code :

    GKH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use for the Immunicon CellTracks™ AutoPrep System is as a generalpurpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole blood. Cell analyzers such as the CellTracks™ Analyzer, CellSpotter™ System, flow cytometers or microscopes may be used for cell identification and enumeration. The system is for in vitro diagnostic use.
    Device Description
    The CellTracks™ AutoPrep System is an automated sample-handling instrument that starts with a tube of anticoagulated whole blood and delivers an enriched, processed sample that is ready to analyze by flow-cytometry, fluorescent microscopy, CellSpotter™ System or by the CellTracks™ Analyzer. The AutoPrep System performs several steps, including red cell detection, plasma aspiration and filling of a sample chamber or test tube. The principal of operation relates to the addition of a ferrofluid, which has been conjugated with monoclonal antibodies that act with the system to magnetically separate the cells of interest and in subsequent steps, within the system, to add fluorescencelabeled monoclonals to further differentiate the captured cells. The first reagent added is ferrofluid, which consists of a magnetic core surrounded by a protein layer coated with antibodies for attachment to cells. Ferrofluid particles are colloidal and when mixed with a sample containing the target cells, they interact and attach to the target cells. The ferrofluid/sample mixture is placed in a strong magnetic field, which causes the labeled target cells to move to the side of the tube. The blood is aspirated, the magnetic field is removed and the cells are resuspended in a small volume of buffer and fluorescent reagents are added for the identification and enumeration of the target cells. Another magnetic separation step and resuspension is performed and the sample is now ready for analysis. The immunomagnetic enrichment process is the new technology but does not raise any new issues of safety and effectiveness.
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    K Number
    K022512
    Device Name
    CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518
    Manufacturer
    IMMUNICON CORP.
    Date Cleared
    2002-09-30

    (62 days)

    Product Code
    GKH
    Regulation Number
    864.5240
    Why did this record match?
    Product Code :

    GKH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Immunicon CellPrep™ Sample Preparation System is a general-purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole blood. Cell analyzers such as the CellTracks™ Analyzer, flow cytometers or microscopes may be used for cell identification and enumeration. The system is for in vitro diagnostic use.
    Device Description
    The CellPrep System is a semi-automated sample-handling instrument that starts with a tube of anticoagulated whole blood and delivers an enriched, processed sample that is ready to analyze by flow-cytometry, fluorescent microscopy or by the CellTracks™ Analyzer. The CellPrep™ System performs several steps, including red cell detection, plasma aspiration and filling of a sample chamber or test tube. The user is prompted to perform various operations such as reagent addition and mixing. The principal of operation relates to the addition of a ferrofluid, which has been conjugated with monoclonal antibodies that act with the system to magnetically separate the cells of interest and in subsequent steps, within the system, to add fluorescence-labeled monoclonals to further differentiate the captured cells. The first reagent added is ferrofluid, which consists of a magnetic core surrounded by a protein layer coated with antibodies for attachment to cells. Ferrofluid particles are colloidal and when mixed with a sample containing the target cells, they interact and attach to the target cells. The ferrofluid/sample mixture is placed in a strong magnetic field, which causes the labeled target cells to move to the side of the tube. The blood is aspirated, the magnetic field is removed and the cells are resuspended in a small volume of buffer and fluorescent reagents are added for the identification and enumeration of the target cells. Another magnetic separation step and resuspension is performed and the sample is now ready for analysis.
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    K Number
    K021150
    Device Name
    COULTER CELLPREP
    Manufacturer
    BECKMAN COULTER, INC.
    Date Cleared
    2002-06-11

    (62 days)

    Product Code
    GKH
    Regulation Number
    864.5240
    Why did this record match?
    Product Code :

    GKH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The COULTER® CellPrep is an automated system that processes human blood for preparation of leukocyte suspensions for quantitative immunofluorescence analysis by optical flow cytometers. The use of data generated by this instrument depends on the regulatory status of the reagents you use. If the reagent is labeled by the manufacturer "For Research Use Only. Not for use in diagnostic procedures," federal law prohibits the use of the data for diagnosis. This product is intended "For In Vitro Diagnostic Use" when using the "IVDImmunophenotype" protocol and processing whole blood samples with COULTER reagents and antibodies labeled for In Vitro Diagnostic Use.
    Device Description
    The COULTER® CellPrep is a compact, fully automated sample processing workstation which can be programmed to perform a variety of cell wash, dilution, and concentration operations.
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