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Abbott FreeStyle Insulinx

Device Name:FreeStyle Insulinx
Manufacturer:Abbott Diabetes Care Inc., 1360 South Loop Road, Alameda, CA 94502, UNITED STATES.
Measuring functions:Blood glucose
Primary Client Use:Intended for self-measurement and home use
Measurement Site:Finger
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment:

The technology used in the Abbott FreeStyle Insulinx, to measure blood glucose, is among the best rated for accuracy by Medaval Ltd. It has passed in clinical validation studies, between general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications.

Accuracy AssessmentRecommendationBasis
Medaval★★★ RecommendationRecent clinical validation; recent protocol; multiple clinical validations
TÜV Rheinland NederlandGeneral useUnpublished internal data
MDR CriteriaSelf-measurementPublished evidence

Validation Publications

Bedini JL, Wallace JF, Pardo S, Petruschke T. Performance Evaluation of Three Blood Glucose Monitoring Systems Using ISO 15197: 2013 Accuracy Criteria, Consensus and Surveillance Error Grid Analyses, and Insulin Dosing Error Modeling in a Hospital Setting. J Diabetes Sci Technol. 2016 Jan;10(1):85-92. Epub: 2015 Oct 7. doi: 10.1177/1932296815609368. PMID: 26445813. Available from: PMC4738222.

15197:2013 - Pass General population

Jendrike N, Baumstark A, Pleus S, Liebing C, Beer A, Flacke F, Haug C, Freckmann G. Evaluation of Four Blood Glucose Monitoring Systems for Self-Testing with Built-in Insulin Dose Advisor Based on ISO 15197:2013: System Accuracy and Hematocrit Influence. Diabetes Technol Ther. 2018 Apr;20(4):303-13. doi: 10.1089/dia.2017.0391. PMID: 29664706.

15197:2013 - Pass General population