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510(k) Data Aggregation
K Number
K991439Device Name
POLLER CALIBRANTS
Manufacturer
Date Cleared
1999-12-20
(238 days)
Product Code
Regulation Number
864.5425Why 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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