5 Evaluation Studies for Prescription POC Monitors This metric is expected to be used by the FDA to assess the performance of cleared blood glucose monitors. An error grid developed by the Diabetes Technology Society in cooperation with the FDA, the American Diabetes Association (ADA), The Endocrine Society (TES), and the Association for Advancement of Medical Instrumentation (AAMI), known as the Surveillance Error Grid, was released this year and is discussed in more detail below. Error grids permit a data set to be defined on the basis of the percentage of data points that fall into each zone of risk. Outcomes can range from appropriate treatment to slightly inadequate treatments requiring no corrections to serious errors causing life-threatening outcomes, with many gradations in between. A set of risk zones is superimposed on the graph such that each zone represents a likely clinical outcome resulting from inaccuracy in the measured glucose values. A blood glucose error grid is a graph that plots blood glucose monitor values on the y-axis and reference blood glucose values on the x-axis. Clinical accuracy is a qualitative metric for describing the clinical outcome of making a treatment decision using the result of a measurement from a device being assessed. Analytical accuracy is a quantitative method for describing how closely the result of a measurement by a device compares with a measurement by a reference method for this assay. 7-2013 (E) Standardīlood glucose monitor performance can be described by analytical accuracy or clinical accuracy. The previous standard, which the FDA used for clearance of both OTC and prescription POC devices was the 2003 International Organization for Standardization (ISO) standard that required 95% of the measured glucose values to fall within ± 15 mg/dl of the average measured values of the reference measurement procedure at glucose concentrations < 75 mg/dl or within ± 20% at glucose concentrations ≥ 75 mg/dl. The proposed prescription POC blood glucose monitor guidance specifies that, to demonstrate that a blood glucose monitoring system is sufficiently accurate to be used safely by HCPs, the manufacturer should demonstrate that 99% of all values are within a range of ± 10% of the reference method for glucose concentrations > 70 mg/dl and within ± 7 mg/dl at glucose concentrations 70 mg/dl or ± 15 mg/dl for samples < 70 mg/dl.
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