Abbott FreeStyle Precision Neo

Description:

The Abbott FreeStyle Precision Neo is an automatic blood glucose meter. Its blood glucose measurement technology has been proven to be accurate, with a 2-star Medaval rating. Blood glucose measurements are taken from the finger. It is intended for self-measurement and home use.

Assessment:

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.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BG	Medaval	★★ Recommendation	Recent clinical validation; recent protocol
BG	Institute of Health Economics (CA)	General use	No evidence provided
BG	MDR Criteria	Self-measurement	Published evidence

	Consumer Body	Year(s)	Level	Comment
BG	Consumer Reports (US)	Latest: 2019-2022	Excellent

Validation Publications:

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