Performance of the GLUCOCARD® Shine XL Blood Glucose Monitoring System Compared with FDA 2016 Guidance Accuracy Criteria

Abstract

Background: Blood Glucose Monitoring Systems (BGMS) are important tools used in the management of diabetes mellitus. Accurate BGMS readings are needed to prevent potential micro and macrovascular complications due to uncontrolled blood glucose levels. The FDA’s 2016 Guidance, “Self-Monitoring Blood Glucose Test Systems for Over-the-Counter (OTC) Use”, is FDA’s recommendation for measuring the accuracy of OTC BGMS. The accuracy boundaries of the guidance require that 95% of all results fall within ±15% of reference and 99% within ±20% of reference. Purpose: This study evaluated the GLUCOCARD® Shine XL BGMS performance against the accuracy boundaries set by the FDA’s 2016 Guidance. Methods: Three lots of test strips were evaluated in a side-by-side comparison at the ARKRAY Factory in Minneapolis, Minnesota. Blood samples were drawn from the fingertip of people with diabetes (n=180) by trained laboratory professionals between November and December 2017. Reference values were obtained using the YSI Model 2300 Analyzer. Data was evaluated against the accuracy boundaries of the FDA’s 2016 Guidance for Self-Monitoring Blood Glucose Test Systems for OTC Use. Results: 98.3% (177/180) of the combined results for the three lots of GLUCOCARD® Shine XL BGMS fell within the ±15% of reference and 99.4% (179/180) were within ±20% of reference. Overall bias was 2.2% and the correlation coefficient was 0.99 (r). Conclusion: The GLUCOCARD® Shine XL BGMS performed within the accuracy boundaries of the FDA’s 2016 Guidance, Self-Monitoring Blood Glucose Test Systems for OTC Use. Disclosure J. Walker: Employee; Self; Arkray, Inc. P. Gill: Employee; Self; Arkray, Inc. D. Maher: Employee; Self; Arkray, Inc. J.M. Gleisner: Employee; Self; Arkray, Inc..