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Abbott Freestyle Precision Pro

Device Name:Freestyle Precision Pro
Manufacturer:Abbott Diabetes Care Inc., 1360 South Loop Road, Alameda, CA 94502, UNITED STATES.
Measuring functions:Blood glucose, Ketones
Primary Client Use:Intended for professional use
Measurement Site:Finger
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment:

The technology used in the Abbott Freestyle Precision Pro, to measure blood glucose, has passed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.

Accuracy AssessmentRecommendationBasis
Medaval★★ RecommendationRecent clinical validation; recent protocol
MDR CriteriaProfessional usePublished evidence

Validation Publications

Brazg R, Hughes K, Martin P, Coard J, Toffaletti J, McDonnell E, Taylor E, Farrell L, Patel M, Ward J, Chen T, Alva S, Ng R. Clinical evaluation of the FreeStyle Precision Pro system. Clin Chim Acta. 2013 Jun 5;421:243-50. Epub: 2013 Mar 26. doi: 10.1016/j.cca.2013.03.021. PMID: 23537735. Available from: www.sciencedirect.com.

15197:2013 - Pass General population

CLSI:2013 - Pass General population