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510(k) Data Aggregation

    K Number
    K991439
    Device Name
    POLLER CALIBRANTS
    Date Cleared
    1999-12-20

    (238 days)

    Product Code
    Regulation Number
    864.5425
    Why did this record match?
    Applicant Name (Manufacturer) :

    EUROPEAN CONCERTED ACTION ON ANTICOAGULATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    - A. To provide calibration of local prothrombin time systems to accord with the WHO prothrombin time (PT) standardisation scheme ("the existing device"). - B. To avoid the need for local availability of an international reference preparation (IRP) for thromboplastin. IRP are not normally available except to national control laboratories and manufacturers. . . - C. To avoid the need for the performance of the manual PT- technique required for conventional WHO calibrations. Most centres have now discarded the manual technique for automated procedures and are no longer skilled in the manual PT technique. - D. To avoid the requirement for fresh plasma donations from 60 patients stabilised on warfarin treatment required for the conventional WHO calibrations. - E. To facilitate serial calibration studies to check against drift of automated instruments or the effect of batch changes of commercial thromboplastin reagent. - F. To provide a rapid result. A PT system calibration with the Calibrants takes about half an hour whereas a conventional WHO calibration requires several days. Five days are recommended by the revised 1999 WHO protocol.
    Device Description
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