Abbott FreeStyle Precision Neo
The technology used in the Abbott FreeStyle Precision 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.
|Medaval||★★ Recommendation||Recent clinical validation; recent protocol|
|Institute of Health Economics (CA)||General use||No evidence provided|
|MDR Criteria||Self-measurement||Published evidence|
|Consumer Reports (US)||2019-2021||Excellent|
Chen T, Robinson C, Alva S, Brannan C. Evaluation of the FreeStyle Precision Pro Blood Glucose and β-Ketone Monitoring System. Point of Care: The Journal of Near-Patient Testing & Technology. 2017 Mar;16(1):55-58 . doi: 10.1097/POC.0000000000000128.
15197:2013 - Pass General population (Note: Laboratory studies demonstrated that the system maintained accuracy in various challenging conditions that may be encountered in everyday home testing. These also demonstrated that influence conditions identified in ISO 15197:2013 (haematocrit & interfering substances) did not influence the FreeStyle Precision Neo system to such an extent that would require description of their effects in the product labelling.)
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 - Fail General population