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510(k) Data Aggregation

    K Number
    K060677
    Device Name
    N LATEX CDT
    Manufacturer
    DADE BEHRING, INC.
    Date Cleared
    2006-08-25

    (164 days)

    Product Code
    NAO, CLA
    Regulation Number
    862.1360
    Why did this record match?
    Product Code :

    NAO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    In vitro diagnostic for the quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum by means of particle-enhanced immunonephelometry using the BN™ II and BN ProSpec® System. The N Latex CDT assay must be run concurrently with the N Antisera to Human Transferrin assay so that the result can be expressed as a relative ratio, i.e., %CDT of the total transferrin. The calculation of %CDT can be used as a tool to identify possible chronic heavy alcohol consumption.
    Device Description
    The CDT in the sample competes with CDT-coated polystyrene particles for the bond to specific monoclonal antibodies against human CDT, which are likewise bound to polystyrene particles. In the presence of CDT in the sample, there is no or little aggregation of the polystyrene particles. In the absence of CDT in the sample, the polystyrene particles aggregate. The higher the CDT content in the assay, the lower the scattered light signal. The evaluation is performed by comparison with a standard of known concentration.
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    K Number
    K001943
    Device Name
    CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAY
    Manufacturer
    SANGUI BIOTECH, INC.
    Date Cleared
    2000-08-23

    (58 days)

    Product Code
    NAO
    Regulation Number
    862.1360
    Why did this record match?
    Product Code :

    NAO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K992502
    Device Name
    AXIS %CDT TURBIDIMETRIC IMMUNOASSAY
    Manufacturer
    AXIS
    Date Cleared
    1999-12-21

    (148 days)

    Product Code
    NAO
    Regulation Number
    862.1360
    Why did this record match?
    Product Code :

    NAO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Axis ® %CDT Turbidimetric Immunoassay (TIA) is intended for the quantitative measurement of carbohydrate deficient transferrin (CDT) in human serum, as a tool to identify possible chronic heavy alcohol consumption. The Axis ® %CDT Turbidimetric Immunoassay is designed for the quantitative determination of carbohydrate deficient transferrin (CDT) in human serum.
    Device Description
    The Axis® %CDT is a heterogeneous immunoassay with column separation followed by turbidimetric measurement. Serum transferrin in the sample is saturated with Fe ". The mixture is applied to an ion-exchange column. Due to the different amounts of sialic residues on transferrin, the isoforms carry different charges and are separated in the column. The CDT isoforms are eluted. The CDT content of the collected eluate is determined by turbidimetric measurement. The eluted CDT isoforms form immune complexes with anti-transferrin antibodies. Total transferrin content of the sample is determined separately, using the same anti- transferrin antibodies. The measurements are evaluated using a calibration curve, and the Axis® %CDT value is calculated.
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