Meeting the New FDA Standard for Accuracy of Self-Monitoring Blood Glucose Test Systems Intended for Home Use by Lay Users.
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ABSTRACT:
SUBMITTER: Katz LB
PROVIDER: S-EPMC7753858 | biostudies-literature | 2020 Sep
REPOSITORIES: biostudies-literature
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Meeting the New FDA Standard for Accuracy of Self-Monitoring Blood Glucose Test Systems Intended for Home Use by Lay Users.
Katz Laurence B LB Stewart Lorna L King Danielle D Cameron Hilary H
Journal of diabetes science and technology 20200214 5
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 ove ...[more]
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