Table 3.

Criteria Published by Different Institutions for Approval of Point-of-Care Blood Glucose Meters.

Year	Standard setting institution and their guideline document	Error margins	Specifically suggested for blood glucose meters in hospital setting
1987	ADA	Acceptable error should be <10% for 100% of glucose results between 30-400 mg/dl	No
1996	ADA	Acceptable error should be <5% for 100% of glucose results between 30-400 mg/dl	No (deemed unachievable by IFCC)
2003	ISO 15197	At ≤75 mg/dl, 95% of results should be within ± 15 mg/dl At >75 mg/dl, 95% of results should be within ± 20%	No (currently adopted by the FDA in the US and CE in Europe for hospital blood glucose meter certification)
2013	ISO 15197	At <100 mg/dl, 95% of results should be within ± 15 mg/dl At ≥100 mg/dl, 95% of results should be within ± 15% 99% of individual results within zones A and B of the consensus error grid (error grid not used in 2003 ISO criteria)	No
2013	CLSI POCT 12-A3 (its previous version had adopted the ISO 15197:2003 criteria)	At <100 mg/dl, 95% of results should be within ± 12 mg/dl At ≥100 mg/dl, 95% of results should be within ± 12.5% At ≤75 mg/dl, 98% of results should be within ± 15 mg/dl At >75 mg/dl, 98% of results should be within ± 20% Blood glucose meters should be evaluated in the populations where they intend to be used	Yes