Meeting the New FDA Standard for Accuracy of Self-Monitoring Blood Glucose Test Systems Intended for Home Use by Lay Users
Laurence B Katz, Lorna Stewart, Danielle King, Hilary Cameron, Laurence B Katz, Lorna Stewart, Danielle King, Hilary Cameron
Abstract
The OneTouch Verio Reflect blood glucose monitor (BGM) has market clearance in several countries based in part on fulfilling the lay user and system accuracy criteria described in ISO15197:2015. However, the Food and Drug Administration (FDA) does not recognize the accuracy criteria in ISO15197 as a basis for gaining regulatory clearance for these devices. The current study evaluates the BGM using the accuracy guidelines issued by the agency for self-monitoring blood glucose test systems for over-the-counter use. Glucose results were accurate vs comparator over a wide glucose range and met lay user and glucose accuracy criteria at extreme glucose values as described in the FDA guidance.Clinicaltrials.gov NCT03851549.
Keywords: accuracy; blood glucose; blood glucose meter; blood glucose strips; self-monitoring of blood glucose.
Conflict of interest statement
Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: LK, LS, DK, and HC are full-time employees of LifeScan Global Corporation.
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Source: PubMed