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Abbott FreeStyle Optium Neo

Device Name:Freestyle Optium Neo
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 Optium Neo, 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 CriteriaSelf-measurementPublished evidence
 
Consumer BodyVersionQuartileComment
Choice (Australia)2019A 

Validation Publications

Freckmann G, Jendrike N, Baumstark A, Pleus S, Liebing C, Haug C. User Performance Evaluation of Four Blood Glucose Monitoring Systems Applying ISO 15197:2013 Accuracy Criteria and Calculation of Insulin Dosing Errors. Diabetes Ther. 2018 Apr;9(2):683-97. Epub: 2018 Mar 3. doi: 10.1007/s13300-018-0392-6. PMID: 29502304. Available from: PMC6104257.

15197:2013 - Pass General population

Tentolouris A, Eleftheriadou I, Grigoropoulou P, Nikoloudi M, Siami E, Tsilimigras DI, Tentolouris N. Accuracy and Usability Evaluation of Six Commercially Available Blood Glucose Monitoring Systems Journal of Clinical and Diagnostic Research. 2018 Jun;12(6):OC10-OC14. doi: 10.7860/JCDR/2018/34055.11671. Available from: www.jcdr.net.

Ad Hoc protocol General population (Note: Tested in criteria resembling ISO 15197:2013.)