Performance of the GLUCOCARD® VitalTM Blood Glucose Monitoring System Compared to FDA 2016 Guidance Accuracy Criteria

Presentation Number: SUN 616
Date of Presentation: April 2nd, 2017

Julie Walker*, Patricia Gill, Danielle Maher and John Gleisner
ARKRAY USA, Minneapolis, MN


Background: Blood Glucose Monitoring Systems (BGMS) are important tools used in the management of diabetes mellitus. In order to prevent potential micro and macrovascular complications due to uncontrolled blood glucose levels, the systems must provide accurate readings. 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 GLUCOCARD® VitalTMBGMS performance compared to accuracy boundaries set by the 2016 FDA Guidance for Self-Monitoring Blood Glucose Test Systems for OTC Use.

Methods: Three lots of test strips were evaluated at the ARKRAY Factory in Minneapolis, MN. Blood samples were drawn from the fingertip of confirmed diabetics (n=180) by laboratory professionals. 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: 97.8% of the combined results for three lots of GLUCOCARD® VitalTMBGMS (176/180) fell within the ±15% of reference and 100.0% (180/180) were within ±20% of reference. Overall bias was -2.4% and correlation coefficient (r) = 0.98. In addition, the individual results for all three lots fell within FDA’s accuracy boundaries (95.0%, 96.3% and 100.0% respectively were within 15% of the reference and 100.0% within 20%).

Conclusion: The GLUCOCARD® VitalTM BGMS performed within the accuracy boundaries of the FDA’s 2016 Guidance, Self-Monitoring Blood Glucose Test Systems for OTC Use. The study also showed that the GLUCOCARD® VitalTM system had consistent lot-to-lot performance.


Disclosure: JW: , ARKRAY USA. PG: , ARKRAY USA. DM: Employee, ARKRAY USA. JG: Employee, ARKRAY USA.