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Table 1 Difference distribution for glucose concentration < 100 mg/dL (5.55
mmol/L)
Difference within
±5mg/dL
Difference within
±10mg/dL
Difference within
±15mg/dL
Table 2 Difference distribution for glucose concentration ≥ 100 mg/dL (5.55
mmol/L)
Difference within
±5mg/dL
Difference within
±10mg/dL
Difference within
±15mg/dL
Precision
In both intermediate precision and repeatability tests, the standard deviation (SD)
is within 5 mg/dL (0.28 mmol/L) for each glucose concentration < 100 mg/dL
(5.55 mmol/L) and the coefficient of variation (CV) is less than 5% for each
glucose concentration ≥ 100 mg/dL (5.55 mmol/L).