Glucose meter to reference method correlation [Ratio] in Serum, Plasma or Blood by calculation

Glucose correlation SerPlBld Calc-Rto

Definition

The glucose correlation is a charted value used to monitor the accuracy of glucose meter results as compared to reference method results for quality assurance purposes. According to draft guidance from the Food and Drug Administration in 2014, for point-of-care blood glucose meter devices used by healthcare providers, 99% of all values should be within 10% of the reference method for glucose concentrations > 70 mg/dL and within 7 mg/dL for glucose concentrations < 70 mg/dL.[http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm380325.pdf] For self-monitoring blood glucose meters used by patients, 95% of all results should be within 15% of the reference method result and 99% of all results should be within 20% of the reference method result across the entire claimed measuring range of the instrument. [http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm380327.pdf]

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