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510(k) Data Aggregation

    K Number
    K120662
    Device Name
    PICCOLO HDL-CAPILLARY TEST SYSTEM
    Manufacturer
    ABAXIS, INC.
    Date Cleared
    2012-04-24

    (50 days)

    Product Code
    JHM
    Regulation Number
    862.1475
    Why did this record match?
    Product Code :

    JHM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Piccolo HDL - Capillary Test System used with the Piccolo xpress Chemistry Analyzer is intended for the in vitro quantitative determination of HDL in capillary (fingerstick) heparinized whole blood in a clinical laboratory setting or point-of-care location. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
    Device Description
    The Piccolo® Lipid Panel – Capillary Reagent Disc (which contains the Piccolo® HDL - Capillary Test System) is designed to separate a heparinized whole blood sample into plasma and blood cells. The disc meters the required quantity of plasma and diluent, mixes the plasma with diluent, and delivers the mixture to the reaction cuvettes along the disc perimeter. The diluted plasma mixes with the reagent beads, initiating the chemical reactions that are then monitored by the analyzer.
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    K Number
    K081300
    Device Name
    DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Date Cleared
    2008-07-02

    (55 days)

    Product Code
    JHM
    Regulation Number
    862.1475
    Why did this record match?
    Product Code :

    JHM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HDLC method is an in vitro diagnostic test for the quantitative measurement of high-density lipoprotein cholesterol (HDL-C) in human serum and plasma on the Dimension Vista® system. Measurements of HDL-C are used as an aid in the diagnosis of lipid disorders (such as diabetes mellitus), various liver and renal diseases and in the assessment of risk for atherosclerosis and cardiovascular disease.
    Device Description
    Dimension Vista® HDCL Flex® reagent cartridge is a pre-packaged in-vitro diagnostic test method (assay) that is specifically designed to be used on the Dimension Vista® Integrated system, a floor model, fully automated microprocessor-controlled, integrated instrument system. The reagents contained in the Dimension Vista® Flex® reagent cartridges are the same as those manufactured for the Dimension® clinical chemistry analyzers. The packaging modification does not affect the fundamental scientific technology of the device. The HDLC assay measures serum HDL cholesterol levels directly without the need for sample pretreatment or separation steps, using a two reagent format. In the first reaction, lipoproteins are precipitated with dextran sulfate in the presence of magnesium sulfate. These complexes are resistant to the polyethylene glycol (PEG)-modified cholesterol esterase (CE) and cholesterol oxidase (CO) that react with HDL cholesterol. In the second reaction, in the presence of oxygen, the HDL cholesterol is oxidized to A-4-cholestenone and hydrogen peroxide. The generated hydrogen peroxide then reacts with 4-aminoantipyrine (4-AAP) and N-ethyl-N-(2-hydroxy-3-sulfopropyl)-3,5-dimethoxyaniline (HSDA) in the presence of peroxidase. The resulting quinoneimine dye is measured using a bichromatic (600/700 nm) technique. The color intensity of the dye is directly proportional to the serum HDL-C concentration.
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    K Number
    K073072
    Device Name
    DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B
    Manufacturer
    DADE BEHRING, INC.
    Date Cleared
    2008-02-21

    (113 days)

    Product Code
    JHM
    Regulation Number
    862.1475
    Why did this record match?
    Product Code :

    JHM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AHDL method is an in vitro diagnostic test for the quantitative measurement of high-density lipoprotein cholesterol (HDL-C) in human serum and plasma on the Dimension® clinical chemistry system. Measurements of HDL-C are used as an aid in the diagnosis of lipid disorders (such as diabetes mellitus), various liver and renal diseases and in the assessment of risk for atherosclerosis and cardiovascular disease.
    Device Description
    The AHDL assay measures HDL cholesterol levels directly without the need for sample pretreatment or specialized centrification steps, using a two reagent format. In the first reaction, chylpmicrons, VLDL and LDL form water soluble complexes with dextran sulfate in the presence of magnesium sulfate. These complexes are resistant to the polyethylene glycol (PEG)-modified cholesteril esterse and cholesterol oxidase that react with HDL cholesterol. In the presence of oxygen, the HDL cholesterol is oxidized to 24-cholestenone and hydrogen peroxide. The generated hydrogen peroxide then reacts with 4-aminoantipyrine and sodium N-(2-hydroxy-3-sulfopropyl)-3,5-dimethoxyaniline (HSDA) in the presence of peroxidase to form a colored dye that is measured using a bichromatic (600/700 nm) endpoint technique. The color intensity of the dye is directly proportional to the serum HDL-C concentration.
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    K Number
    K032798
    Device Name
    DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A
    Manufacturer
    DADE BEHRING, INC.
    Date Cleared
    2003-10-30

    (51 days)

    Product Code
    JHM
    Regulation Number
    862.1475
    Why did this record match?
    Product Code :

    JHM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AHDL method for the Dimension® clinical chemistry system is an in vitro diagnostic test intended to quantitatively measure high density lipoprotein cholesterol (HDL-C) in human serum and plasma. HDL-C measurements are used as an aid in the diagnosis of lipid disorders.
    Device Description
    The Dimension® Automated HDL Cholesterol (AHDL) Flex® reagent cartridge (DF48A) is an in vitro diagnostic device that consists of prepackaged reagents in a plastic cartridge (Flex®) for use on the Dade Behring Dimension® clinical chemistry system.
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    K Number
    K022519
    Device Name
    LDL CHOLESTEROL (AUTOMATED)
    Manufacturer
    JAS Diagnostics, Inc.
    Date Cleared
    2002-09-30

    (62 days)

    Product Code
    JHM, JIX, JJY, MRR
    Regulation Number
    862.1475
    Why did this record match?
    Product Code :

    JHM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for the In Vitro, quantitative determination of LDL Cholesterol in human serum on automated chemistry analyzers. LDL Cholesterol measurements are used in the diagnosis and treatment of disorders involving high LDL Cholesterol, which is associated with an increased risk of coronary heart disease and coronary artery disease.
    Device Description
    Not Found
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    K Number
    K983849
    Device Name
    DIMENSION AUTOMATED HIGH DENSITY LIPOPROTEIN CHOLESTEROL (ADHL) FLEX REAGENT CARTRIDGE
    Manufacturer
    DADE BEHRING, INC.
    Date Cleared
    1999-01-11

    (73 days)

    Product Code
    JHM
    Regulation Number
    862.1475
    Why did this record match?
    Product Code :

    JHM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AHDL method for the Dimension® clinical chemistry system is a device used to quantitatively measure High Density Lipoprotein Cholesterol in human serum or plasma. AHDL measurements are used as an aid in the diagnosis and treatment of lipid disorders.
    Device Description
    The AHDL method for the Dimension® clinical chemistry system is a homogeneous method for direct measurement of high density lipoprotein (HDL) cholesterol levels without the need for off-line pretreatment or centrifugation steps. The method is in a two-reagent format and depends on the properties of a unique detergent, which solubilizes only the HDL particles, thus releasing HDL cholesterol to react with cholesterol esterase to produce color. In addition to selectively disrupting the HDL particles, this detergent also inhibits the reaction of the cholesterol enzymes with LDL, VLDL and chylomicrons by adsorbing to their surfaces. A polyanion is contained in the first reagent to assist with complexing LDL, VLDL and chylomicrons, further enhancing the selectivity of the detergent and enzymes for HDL cholesterol.
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