Owner’s Manual
AutoCode
®
Blood Glucose Meter
70
2. The accuracy requirements for the blood glucose
monitoring system—meters and test strips—as stated
in ISO 15197 are:
Ninety-ve percent (95%) of the individual glucose
results shall fall within ±15 mg/dL (0.83 mmol/L)
of the results of the manufacturer’s measurement
procedure at glucose concentrations < 75 mg/
dL (< 4.2 mmol/L) and within ± 20% at glucose
concentrations ≥ 75 mg/dL ( ≥ 4.2 mmol/L).
How does this answer the FAQ?
The accuracy of the system is determined by a clinical
study using 100 blood samples at interval glucose con
-
centrations ranging from < 50 mg/ dL to over 400 mg/
dL measured using both the manufacturer’s meter and
a clinical blood glucose analyzer for comparison (refer-
ence measurement).
Example
If the manufacturer’s reference measurement is
70 mg/dL this means that the meter measurements
are considered accurate if they fall within ± 15 mg/dL
of 70 mg/dL (from 55 mg/dL to 85 mg/dL).
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