FDA Meeting: Clinical Accuracy Requirements for Point of Care Blood Glucose Meters

Prevalence and predictors of diabetes and cardiometabolic risk among construction workers in Ireland: The Construction Workers Health Trust screening study

“…quality control performance and sample volume). 35 –37 To minimise the latter, practise nurses in our study were trained and competent in the use of the HemoCue. Although the benefit of POC testing is the immediate analytical information it provides, our study indicates that confirmation by laboratory glucose analysis on venous plasma should remain the standard on which clinical decisions are made.…”

A Milestone in Point of Care Capillary Blood Glucose Monitoring of Critically Ill Hospitalized Patients

“…In 2010, the FDA held a public meeting titled “Clinical Accuracy Requirements for Point of Care Blood Glucose Meters.” The purpose of the public meeting was to discuss the clinical accuracy requirements of blood glucose meters and other topics related to their use in POC settings. 8 The ideas discussed there became the basis for a 2014 draft guidance on Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use.…”

Regulatory Controversies Surround Blood Glucose Monitoring Devices

“…1 The meeting's goals are to: (1) raise public awareness about the accuracy and clinical use of BG meters; (2) obtain public input about the accuracy and clinical use of BG meters; and (3) work toward identifying solutions. The meeting's three sessions will cover: (1) clinical accuracy requirements for BG meters; (2) BG meter performance, interferences, and limitations; and (3) tight glycemic control, especially in the hospital setting.…”