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510(k) Data Aggregation

    K Number
    K000661
    Device Name
    RANDOX PREALBUMIN
    Manufacturer
    RANDOX LABORATORIES, LTD.
    Date Cleared
    2000-04-13

    (45 days)

    Product Code
    JZJ
    Regulation Number
    866.5060
    Why did this record match?
    Product Code :

    JZJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K972638
    Device Name
    TINA-QUANT PREALBUMIN
    Manufacturer
    BOEHRINGER MANNHEIM CORP.
    Date Cleared
    1998-01-09

    (178 days)

    Product Code
    JZJ
    Regulation Number
    866.5060
    Why did this record match?
    Product Code :

    JZJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Immunoturbidometric assay for the quantitative in-vitro determination of Prealbumin. Immunological latex agglutination test for the in vitro quantitative determination of prealbumin in human serum and plasma. Measurement of prealbumin levels in serum may aid in the assessment of the patient's nutritional status.
    Device Description
    The Prealbumin determination is based upon turbidimetric immunoinhibition (TINIA) using a serum or plasma blood sample. The sample containing Prealbumin is transferred into a TRIS buffer solution (R₁ reagent). In the second step, an aliquot of solution of polyclonal anti-human Prealbumin antibodies (R₂ reagent) is added to mixture of the first step. The antibody binds to the Prealbumin in the sample to form "aggregates" such that the amount of aggregate formed is proportionate to the amount of Prealbumin present in the sample. The resulting agglutination complex is measured turbidimetrically whereby increased turbidity is reflected through an increase in optical density. Therefore, the amount of Prealbumin in the sample is directly proportional to the amount of turbidity formed.
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