Table 4.

SMBG System Accuracy Evaluation: Test Procedure Requirements Described in the FDA Draft Guidance for Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use, Published in 2014, for Method Comparison/User Evaluation and Accuracy Evaluation at Extreme Glucose Values.

	FDA
General study design
Number of test strip lots	3
Reference measurement procedure	Any method with verified metrological traceability
Evaluation of the instruction for use	Readability assessment using a computer program
Method comparison/user evaluation
Performance of measurements with the SMBG system	At least 350 intended users (at least 10% naïve to the use of SMBG systems)
Training material	Instructions for use, etc routinely provided with the system
Collection of samples for reference measurements	After the subject’s measurement with the SMBG system by medical/laboratory personnel
Sample type/number	Capillary whole blood/at least 350 each site (fingertip, forearm, palm, etc)
Glucose concentrations	• Samples shall span the measuring range of the system (minimum range of 50-400 mg/dl is required)
	• At least 10 unaltered samples <80 mg/dl
	• At least 10 unaltered samples ≥250 mg/dl
Accuracy evaluation at extreme glucose values
Performance of measurements with the SMBG system	laboratory/medical personnela
Glucose concentrations	• At least 50 capillary samples adjusted to <80 mg/dl
	• At least 50 capillary samples adjusted to >250 mg/dl
	• Samples shall cover the lower and upper limits of the claimed measuring range (minimum range of 50-400 mg/dl is required)

^aNot clearly defined but indicated (“laboratory setting”).