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510(k) Data Aggregation

    K Number
    K972609
    Device Name
    VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM
    Manufacturer
    BIO-RAD
    Date Cleared
    1997-08-06

    (26 days)

    Product Code
    LCQ, LCB
    Regulation Number
    862.3450
    Why did this record match?
    Product Code :

    LCQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VARIANT Express Glycohemoglobin Program is intended for the separation and area percent determination of glycohemoglobin (GHb) in whole blood using boronate affinity high performance liquid chromatography (HPLC).
    Device Description
    The Bio-Rad VARIANT Express Glycohemoglobin Program is designed for use on the Bio-Rad VARIANT Express Instrument. The analytical system, consisting of instrument, software and reagent kit, provides an assay for the separation and percent determination of glycohemoglobin in whole blood. The VARIANT Express Glycohemoglobin Program is for use on the fully automated VARIANT Express analyzer. The analytical system of instrument and reagent kit provides a means of measuring a mixture of hemoglobins, each formed by the non-enzymatic attachment of circulating blood glucose to a receptive amino acid site on the hemoglobin molecule (HbAo). Attachment of glucose to hemoglobin is achieved in a two step process: formation of an unstable aldimine (Schiff base) intermediate followed by production of a stable ketoamine linkage. Formation of the Schiff base intermediate is a reversible reaction and is influenced by short-term blood glucose fluctuations. In contrast, conversion of the Schiff base intermediate to the "ketoamine" products (Total GHb) is much slower and irreversible. The percentage of total glycated hemoglobin in whole blood is dependent upon the level of sustained blood glucose and is indicative of mean blood glucose over the lifetime of red blood cells (~120 days). Thus, monitoring of total GHb levels has become a routine test for the long-term management of patients with diabetes mellitus.
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    K Number
    K955569
    Device Name
    INNOFLUOR GENTAMICIN ASSAY SYSTEM
    Manufacturer
    OXIS INTL., INC.
    Date Cleared
    1996-02-09

    (65 days)

    Product Code
    LCQ
    Regulation Number
    862.3450
    Why did this record match?
    Product Code :

    LCQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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