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510(k) Data Aggregation

    K Number
    K960785
    Device Name
    LFS LIPOGEL ASSAY KIT
    Manufacturer
    Date Cleared
    1996-09-03

    (190 days)

    Product Code
    Regulation Number
    862.1475
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZAXIS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Assay Kit is indicated LFS Lipogel for the electrophoretic separation of lipoproteins in a gradient polyacrylamide gel. That is, the LFS Lipogel Assay Kit is an in vitro diagnostic device intended to test human plasma or serum for lipoproteins and their subfractions.
    Device Description
    The LFS Lipogel Assay Kit utilizes a gel electrophoresis method for separating lipoproteins. The principle of electrophoresis is based upon the fact that lipoproteins, when placed in an electrical field, will migrate toward one of the electrode poles. The lipids in human plasma are bound to protein and circulate throughout the body as complexes known as lipoproteins. Routine electrophoresis separates lipoprotein complexes into four generally distinct, well-resolved fractions or zones. lach fraction is composed of one or more individual lipoproteins. From the fastest migrating to the slowest, these fractions have been b designated alpha a 2 lipoproteins (high density lipoproteins - HDL), pre-beta lipoproteins (very low density lipoproteins - VLDL), beta lipoproteins (low density lipoproteins -LDL) , , , and chylomicrons. The resulting pattern may be visually interpreted or quantified. After electrophoresis, the lipoproteins in the gel are immobilized in a fixative solution. The lipoprotein pattern is visualized by staining the qel lipid-specific stain. with a With the use of densitometer, the relative percentage of each lipoprotein fraction can be determined. The LFS Lipogel Assay Kit is a complete system containing the reagents, gels, and hardware necessary to perform electrophoretic separation of lipoproteins.
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