Table 3.

Summary of Analytical Performance Evaluation of the Test Strip (ISO 15197:2003 Section 7 and ISO 15197:2013 Section 6.3)

Meter system	Reference method	Readings within specificed error limits (N = 600)		R2	Parkes consensus error grid analysis
		ISO 15197:2003 criteriaa	R2 ISO 15197:2013 criteriab
CXT/CNEZ16,33	YSI	100%	100%	0.9964	100% in zone A
CNL13,33	YSI	100%	100%	0.9961	100% in zone Ac
CNUSB14,33	YSI	100%	100%	0.9957	100% in zone A
CN15,33	YSI	100%	99.8%	0.9959	100% in zone A

^aWithin ISO 15197:2003 accuracy criteria (i.e., ≥95% of results shall fall within ±15 mg/dl or ±20% for samples with glucose concentrations < 75 and ≥75 mg/dl, respectively).

^bWithin ISO 15197:2013 accuracy criteria (i.e., ≥95% of results shall fall within ±15 mg/dl or ±15% for samples with glucose concentrations <100 and ≥100 mg/dl, respectively).

^cData on file.