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510(k) Data Aggregation

    K Number
    K143691
    Device Name
    LDLC3 LDL-Cholesterol Gen.3
    Manufacturer
    Roche Diagnostics Operations (RDO)
    Date Cleared
    2015-01-28

    (35 days)

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

    LBR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LDL-Cholesterol Gen. 3 assay is an in-vitro test for the quantitative determination of LDL-cholesterol in human serum and plasma on Roche/Hitachi cobas c systems. 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 LDL-Cholesterol Gen. 3 assay is a homogeneous enzyme colorimetric assay which provides the quantitative measurement of LDL-cholesterol in human serum and plasma. Reagents are packaged in a cassette labeled with their instrument positioning R1 (Reagent 1) and R2 (Reagent 2). R1 contains Bis-trisb) buffer: 20.1 mmol/L, pH 7.0; 4-aminoantipyrine:0.98 mmol/L; ascorbic oxidase (AOD, Acremonium spec.): ≥ 66.7 µkat/L; peroxidase (recombinant from Basidiomycetes): ≥ 166.7 µkat/L; BSA: 4.0 g/L; preservative R2 contains MOPSC) buffer: 20.1 mmol/L, pH 7.0; EMSE: 2.16 mmol/L, cholesterol esterase (Pseudomonas spec.): ≥ 33.3 µkat/L; cholesterol oxidase (recombinant from E.coli)): ≥ 31.7 µkat/L; peroxidase (recombinant from Basidiomycetes): ≥ 333.3 µkat/L; BSA: 4.0 g/L; detergents; preservative
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    K Number
    K072523
    Device Name
    DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS
    Manufacturer
    GENERAL ATOMICS
    Date Cleared
    2008-01-22

    (137 days)

    Product Code
    LBR, JJX
    Regulation Number
    862.1475
    Why did this record match?
    Product Code :

    LBR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Diazyme LDL-Cholesterol Assay is intended for the in vitro quantitative determination of Low Density Lipoprotein Cholesterol in human serum or plasma. The reagents can assist in the diagnosis and treatment of patients at risk of developing coronary heart disease. Elevated LDL cholesterol is the primary target of cholesterol-lowering therapy.
    Device Description
    The assay is based on a modified polyvinyl sulfonic acid (PVS) and polyethylene-glycol methyl ether (PEGME) coupled classic precipitation method with the improvements in using optimized quantities of PVS/PEGME and selected detergents. LDL, VLDL. and chylomicron (CM) react with PVS and PEGME and the reaction results in inaccessibility of LDL, VLDL and CM by cholesterol oxidase (CHOD) and cholesterol esterase (CHER), whereas HDL reacts with the enzymes. Addition of R2 containing a specific detergent releases LDL from the PVS/PEGME complex. The released LDL reacts with the enzymes to produce H2O2 which is quantified by the Trinder reaction.
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    K Number
    K050823
    Device Name
    DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR
    Manufacturer
    TECO DIAGNOSTICS
    Date Cleared
    2005-07-26

    (117 days)

    Product Code
    LBR, JIS
    Regulation Number
    862.1475
    Why did this record match?
    Product Code :

    LBR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Teco Direct HDL/LDL Calibrator is used for the calibration of Teco Diagnostics' Direct HDL and Direct LDL Cholesterol Reagent Set in serum or plasma and with Teco Direct HDL Cholesterol Reagent for the quantitative determination of high density lipoprotein cholesterol (HDL-C) in human serum or plasma. HDL quantitative determination is used in identifying patients who are at a higher risk for coronary heart diseases. Low HDL cholesterol levels are associated with an increased risk. This reagent set is intended for in vitro diagnostic use only.
    Device Description
    Direct HDL Cholesterol Reagent and Direct HDL/LDL Calibrator
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    K Number
    K023784
    Device Name
    RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER
    Manufacturer
    HEMAGEN DIAGNOSTICS, INC.
    Date Cleared
    2002-12-24

    (42 days)

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

    LBR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Raichem Cholesterol Rapid Liquid Reagent may be used with the CANTROL® HDL Cholesterol Precipitating Reagent Tubes to separate and determine HDL cholesterol in serum or EDTA plasma on the Cobas Mira chemistry systems. High-density lipoprotein measurement in conjunction with other lipid determinations has been shown to be useful in assessing the risk of coronary artery disease. For In Vitro Diagnostic Use Only.
    Device Description
    Not Found
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    K Number
    K012593
    Device Name
    VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2
    Manufacturer
    Ortho-Clinical Diagnostics, Inc.
    Date Cleared
    2001-08-30

    (20 days)

    Product Code
    LBR, JIS
    Regulation Number
    862.1475
    Why did this record match?
    Product Code :

    LBR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For in vitro diagnostic use only. The VITROS Magnetic HDL-Cholesterol Reagent and VITROS CHOL Slides quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma. VITROS Calibrator Kit 2 For in vitro diagnostic use only. VITROS Calibrator Kit 2 is intended for use in calibration of the VITROS Chemistry Systems for the quantitative measurement of CHOL, Cl-, ECO2, HDLC, K+, Na+, and TRIG.
    Device Description
    The VITROS Chemistry Products Magnetic HDL-Cholesterol Reagent and VITROS CHOL Slides (modified) and VITROS Chemistry Products Calibrator Kit 2
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    K Number
    K992029
    Device Name
    ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS
    Manufacturer
    ELAN DIAGNOSTICS
    Date Cleared
    1999-08-12

    (57 days)

    Product Code
    LBR, JIS
    Regulation Number
    862.1475
    Why did this record match?
    Product Code :

    LBR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ATAC Direct HDL Cholesterol Reagent Kit and the ATAC HDL-C Calibrator are intended for the quantitative determination of high density lipoprotein cholesterol in serum on the ATAC 6000 Chemistry Analyzer. HDL-cholesterol results are used in the diagnosis and treatment of lipid disorders and various liver and renal diseases, and as a tool to assess the risk of developing and managing the progression of cardiovascular disease.
    Device Description
    The ATAC Direct HDL Cholesterol Reagent determines HDL-cholesterol through the enzymatic action of cholesterol esterase, cholesterol oxidase and peroxidase after the selective removal non-HDL sources of cholesterol. The resulting increase in absorbance at 578 nm is proportional to the HDL cholesterol concentration in the sample.
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    K Number
    K992002
    Device Name
    AUTOHDL CHOLESTEROL REAGENT SET
    Manufacturer
    POINTE SCIENTIFIC, INC.
    Date Cleared
    1999-08-05

    (51 days)

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

    LBR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of high density lipoprotein (HDL) cholesterol in serum or plasma. HDL cholesterol is recognized as a useful tool in identifying patients who are at a higher risk for coronary heart disease. Low HDL cholesterol levels are associated with an increased risk. This reagent set is intended for in vitro diagnostic use only.
    Device Description
    Not Found
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    K Number
    K991789
    Device Name
    ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS
    Manufacturer
    ELAN HOLDINGS, INC.
    Date Cleared
    1999-07-09

    (45 days)

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

    LBR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ATAC-PAK Direct HDL Cholesterol Reagent Kit, the ATAC HDL-C Calibrator and the ATAC 8000 Random Access Chemistry System are intended for use as a system for the quantitative determination of high density in serum. HDL-cholesterol results are used in the diagnosis and treatment of lipid disorders, atherosclerosis and various liver and renal diseases, and as a tool to assess the risk of developing and managing the progression of cardiovascular disease. This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.
    Device Description
    The ATAC-PAK Direct HDL Cholesterol Reagent Kit, the ATAC HDL-C Calibrator and the ATAC 8000 Random Access Chemistry System are used as a system for the quantitative analysis of high density lipoprotein cholesterol (HDL-C) in serum. HDL-cholesterol results are used in the diagnosis and treatment of lipid disorders and various liver and renal diseases, and as a tool to assess the risk of developing and managing the progression of cardiovascular disease. The ATAC-PAK Direct HDL Cholesterol Reagent determines HDL-cholesterol through the enzymatic action of cholesterol esterase, cholesterol oxidase and peroxidase after the selective removal non-HDL sources of cholesterol. The resulting increase in absorbance at 578 nm is proportional to the HDL cholesterol concentration in the sample.
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    K Number
    K990247
    Device Name
    MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470
    Manufacturer
    POLYMER TECHNOLOGY SYSTEMS, INC.
    Date Cleared
    1999-05-28

    (122 days)

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

    LBR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MTM BioScanner HDL Test Strip is intended for the in-vitro-diagnostic quantitation of HDL Cholesterol in whole blood when used with the MTM BioScanner 1000. This system is intended to be used to assist the healthcare professional in screening for decreased levels of HDL Cholesterol as a risk factor in coronary artery disease.
    Device Description
    Not Found
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    K Number
    K984303
    Device Name
    VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT
    Manufacturer
    Ortho-Clinical Diagnostics, Inc.
    Date Cleared
    1999-01-28

    (57 days)

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

    LBR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For in vitro diagnostic use only. The VITROS Magnetic HDL reagent and VITROS Cholesterol slides quantitatively measure HDL-cholesterol (HDLC) in serum and plasma.
    Device Description
    Not Found
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