(238 days)
- 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.
Not Found
This document is a 510(k) clearance letter from the FDA for "Poller Calibrants," a device used for prothrombin time systems standardization. The letter itself does not contain detailed information about the acceptance criteria and the comprehensive study that proves the device meets those criteria. The provided text is regulatory correspondence granting marketing clearance based on substantial equivalence to a predicate device.
Therefore, I cannot provide the requested information about acceptance criteria and the study details based solely on the provided text. The document refers to the "indications for use stated in the enclosure," which is not fully included, and does not provide specifics on performance studies or validation data.
To answer your request, I would need access to the actual 510(k) submission (K991439) for the "Poller Calibrants," which would typically contain the detailed study plan, acceptance criteria, results, and other technical documentation.
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.