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510(k) Data Aggregation

    K Number
    K091741
    Device Name
    TINA-QUANT CERULOPLASMIN
    Manufacturer
    Roche Diagnostics
    Date Cleared
    2010-03-18

    (275 days)

    Product Code
    CHN
    Regulation Number
    866.5210
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    Product Code :

    CHN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Immunoturbidimetric assay for the quantitative in vitro determination of ceruloplasmin in human serum and plasma on Roche automated clinical chemistry analyzers. Measurements obtained by this device aid in the diagnosis of copper metabolism disorders.
    Device Description
    The Tina-quant Ceruloplasmin assay employs an immunoturbidimetric test in which anti-ceruloplasmin antibodies react with antigen in the sample to form antigen/antibody complexes which, following agglutination can be determined turbidimetrically.
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    K Number
    K063655
    Device Name
    DIMENSION VISTA; CER FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, PROTEIN 1 CONTROL HIGH
    Manufacturer
    DADE BEHRING, INC.
    Date Cleared
    2007-02-15

    (69 days)

    Product Code
    CHN, JIX, JJY
    Regulation Number
    866.5210
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    Product Code :

    CHN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dimension Vista™ CER Flex® reagent cartridge: The CER method is an in vitro diagnostic test for the quantitative determination of Ceruloplasmin in human serum, heparinized plasma or EDTA plasma on the Dimension Vista System. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorders. Dimension Vista™ Protein 1 Calibrator: PROT1 CAL is an in vitro diagnostic product for the calibration of the C3 Complement (C3), C4 Complement (C4), Ceruloplasmin (CER), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM) and Prealbumin (PREALB) methods on the Dimension Vista® System. Dimension Vista" Protein 1 Control L, M and H: PROT1 CON L, M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of C3 Complement (C3), C4 Complement (C4), ceruloplasmin (CER), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB) on the Dimension Vista® System.
    Device Description
    Dimension Vista™ CER Flex® reagent cartridge: 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™ Protein 1 Calibrator: Protein 1 Calibrator is a multi-analyte, liquid, human serum based product containing C3 complement, C4 complement, ceruloplasmin (CER), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB). Dimension Vista™ Protein 1 Control L, M and H: Protein 1 Control L, M and H are multi-analyte, liquid, human serum based products containing C3 complement, C4 complement, ceruloplasmin (CER), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB).
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    K Number
    K062114
    Device Name
    CERULOPLASMIN, MODEL 2055953
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Date Cleared
    2007-01-31

    (191 days)

    Product Code
    CHN
    Regulation Number
    866.5210
    Why did this record match?
    Product Code :

    CHN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    COBAS INTEGRA Ceruloplasmin: Ceruloplasmin Indications For Use: COBAS INTEGRA: In vitro test for the quantitative immunological determination of ceruloplasmin in human serum and plasma on COBAS INTEGRA systems. Measurements of Ceruloplasmin aid in the diagnosis of copper metabolism disorders. Roche/Hitachi cobas c systems: In vitro test for the quantitative determination of ceruloplasmin in human serum and plasma on Roche/Hitachi cobas c systems. Measurements of Ceruloplasmin aid in the diagnosis of copper metabolism disorders.
    Device Description
    The COBAS INTEGRA Ceruloplasmin cassette (CERU) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA SYSTEMS for the quantitative immunological determination of human ceruloplasmin in serum and plasma. The calibrator and control were cleared via K954992. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorders. The test principle is an immunoturbidimetric assay. The calibrator is Serumproteins T Standard and the recommended control material is the Serumproteins T Control.
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