# K991439: Poller Calibrants

- Pathway: 510(k) (Traditional)
- Applicant: European Concerted Action on Anticoagulation
- Decided: Dec 20, 1999 after 238 days
- Product code: GGN (Plasma, Coagulation Control)
- Device class: 2
- Regulation: 21 CFR 864.5425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for 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 systém 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.

Source page: https://510kreport.com/device/K991439
Methodology: https://510kreport.com/methodology