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510(k) Data Aggregation

    K Number
    K072977
    Device Name
    DIAZYME APOLIPOPROTEIN A-1 ASSAY
    Manufacturer
    GENERAL ATOMICS
    Date Cleared
    2008-07-16

    (268 days)

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

    MSJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Diazyme Apolipoprotein A-I Assay is intended for the in vitro quantitative determination of apolipoprotein A-I (apo A-I) in serum. It can be used as an aid for assessing the risk of coronary artery disease. For in vitro Diagnostic use. Calibrator: For calibration of the Diazyme Apolipoprotein A-I Assay in serum. For in vitro Diagnostic Use. Controls: To monitor the performance of Diazyme Apolipoprotein A-I Assay in serum. For in vitro Diagnostic Use.
    Device Description
    This method is based on the reaction of a sample containing human Apo A-I and specific antiserum to form an insoluble complex which can be measured turbidimetrically at 340nm. By constructing a standard curve from the absorbance of standards the concentration of Apo A-1 can be determined.
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    K Number
    K073488
    Device Name
    DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX
    Manufacturer
    DIAZYME LABORATORIES
    Date Cleared
    2008-03-07

    (137 days)

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

    MSJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Diazyme Apolipoprotein B Assay is intended for the quantitative determination of apolipoprotein B (apo B) in serum. It can be used as an aid for assessing the risk of coronary artery disease. For in vitro Diagnostic use.
    Device Description
    Not Found
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    K Number
    K061377
    Device Name
    APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS
    Manufacturer
    POINTE SCIENTIFIC, INC.
    Date Cleared
    2007-03-28

    (315 days)

    Product Code
    MSJ, JIT
    Regulation Number
    862.1475
    Why did this record match?
    Product Code :

    MSJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These products are to be used for the quantitative determination of apolipoprotein A1 and apolipoprotein B in human serum by immunoturbidimetric analysis. The determination of apolipoprotein A1 and apolipoprotein B are commonly performed as an aid in the assessment of individuals who are at risk for developing coronary artery disease.
    Device Description
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    K Number
    K063608
    Device Name
    DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH
    Manufacturer
    DADE BEHRING, INC.
    Date Cleared
    2007-02-23

    (81 days)

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

    MSJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dimension Vista" APOAI Flex® reagent cartridge: The APOAI method is an in vitro diagnostic test for the quantitative determination of apolipoprotein A-1 in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Measurements of apolipoprotein A-I aid in the diagnosis and treatment of lipid disorders, various liver and renal diseases and in the assessment of risk for atherosclerosis and cardiovascular disease. Dimension Vista™ APOB Flex® reagent cartridge: The APOB method is an in vitro diagnostic test for the quantitative determination of apolipoprotein B in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Measurements of apolipoprotien B aid in the diagnosis and treatment of lipid disorders, various liver and renal diseases and in the assessment of risk for atherosclerosis and cardiovascular disease. Dimension Vista" Apolipoprotein Calibrator: The APO CAL is an in vitro diagnostic product for the calibration of the apolipoprotein A-I (APOAI) and apolipoprotein B (APOB) methods on the Dimension Vista® System. Dimension Vista™ Apolipoprotein Control: APO CON is an assayed intralaboratory quality control for assessment of precision and analytical bias in determination of apolipoprotein A-I (APOAI) and apolipoprotein B (APOB) on the Dimension Vista® System.
    Device Description
    Dimension Vista™ APOAI and APOB Flex® reagent cartridges: Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration. Dimension Vista" Apolipoprotein Calibrator: APO CAL is a multi-analyte, lyophilized, human serum based product containing apolipoprotein A-I and apolipoprotein B. Dimension Vista™ Apolipoprotein Control: APO CON is a multi-analyte, lyophilized, human serum based product containing apolipoprotein A-I and apolipoprotein B.
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    K Number
    K992662
    Device Name
    8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
    Manufacturer
    BAYER CORP.
    Date Cleared
    2000-02-15

    (190 days)

    Product Code
    MSJ, CFN, DCN, JNM, KHS
    Regulation Number
    862.1475
    Why did this record match?
    Product Code :

    MSJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bayer ADVIA 1650 Apolipoprotein A-1 (APO-A) assay is an in vitro diagnostic method intended to measure Apolipoprotein A-1 concentration in human serum and plasma on an Advia 1650 Chemistry System. Measurements are used to aid in the assessment of risk for arteriosclerosis and coronary artery disease. The Bayer ADVIA 1650 Apolipoprotein B (APO-B) assay is an in vitro diagnostic method intended to measure Apolipoprotein B concentration in human serum and plasma on an Advia 1650 Chemistry System. Measurements are used to aid in the assessment of risk for arteriosclerosis and coronary artery disease. The Bayer ADVIA 1650 Carbon Dioxide (CO2) assay is an in vitro fliagnostic method intended to measure Carbon Dioxide concentration in human serum and plasma on an Advia 1650 Chemistry System. Measurements obtained using this method assist in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. The Bayer ADVIA 1650 C-Reactive Protein (CRP) assay is an in vitro diagnostic method intended to measure C-Reactive Protein concentration in human serum and plasma on an Advia 1650 Chemistry System. Measurements are used to aid in the evaluation of the amount of injury to body tissues. This test is useful in following the progress of rheumatic fever, rheumatoid arthritis, myocardial infarction, and malignancies. The Bayer ADVIA 1650 Immunoglobulin A (IGA) assay is an in vitro diagnostic method intended to measure Immunoglobulin A (IGA) concentration in human serum and plasma on an Advia 1650 Chemistry System. Measurements are used to aid in the diagnosis of abnormal protein metabolism and the body's inability to resist infectious agents. The Bayer ADVIA 1650 Immunoglobulin G (IGG) assay is an in vitro diagnostic method intended to measure Immunoglobulin G (IGG) concentration in human serum and plasma on an Advia 1650 Chemistry System. Measurements are used to aid in the diagnosis of abnormal protein metabolism and the body's inability to resist infectious agents. The Bayer ADVIA 1650 Immunoglobulin M (IGM) assay is an in vitro diagnostic method intended to measure Immunoglobulin M (IGM) concentration in human serum and plasma on an Advia 1650 Chemistry System. Measurements are used to aid in the diagnosis of abnormal protein metabolism and the body's inability to resist infectious agents. The Bayer ADVIA 1650 Transferrin (TFR) assay is an in vitro diagnostic device intended to measure Transferrin concentration in human serum and plasma on an Advia 1650 Chemistry System. Such measurements are used to aid in the diagnosis of malnutrition, chronic infection, acute hepatitis, polycythemia, pernicious anemia, and red blood cell disorders, such as iron deficiency anemia.
    Device Description
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    K Number
    K970314
    Device Name
    SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS
    Manufacturer
    BECKMAN INSTRUMENTS, INC.
    Date Cleared
    1997-04-21

    (87 days)

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

    MSJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SYNCHRON LX Systems Apolipoprotein A-1 (ApoA) reagent, when used in conjunction with SYNCHRON Systems APO CAL, is intended for the quantitative determination of human apolipoprotein A-1 in serum or plasma. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON LX™20 Clinical System. The SYNCHRON LX Systems Apolipoprotein B (ApoB) reagent, when used in conjunction with SYNCHRON Systems APO CAL, is intended for the quantitative determination of human apolipoprotein B in serum or plasma. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON LX™20 Clinical System.
    Device Description
    The SYNCHRON LX™ Systems Apolipoprotein ApoA and ApoB Reagents in conjunction with SYNCHRON Systems APO CAL, are intended for use on Beckman's SYNCHRON LX Clinical Systems.
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    K Number
    K964010
    Device Name
    IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN B REAGENT
    Manufacturer
    BECKMAN INSTRUMENTS, INC.
    Date Cleared
    1997-02-10

    (126 days)

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

    MSJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IMMAGE Immunochemistry System Apoliooprotein A-1 (APA) and B (APB) Reagents, in conjunction with Beckman Apolipoprotein Calibrator (APO Cal), are intended for use in the quantitative determination of apolipoprotein A-1 and B in human serum samples by nephelometric immunoassay. These assays are designed for use with the IMMAGE Immunochemistry System.
    Device Description
    The IMMAGE System Apolipoprotein A-1 (APA) and B (APB) Reagents are designed for optimal performance on the IMMAGE Immunochemistry System. They are intended for use in the quantitative determination of apolipoprotein A-1 and B concentrations in human serum samples.
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