FED BGM-II Manual page 8

V. V. V. V. Test Test Test Performance Performance Performance of of of of Blood
Test Performance
Test Test Strip Strip
Test Test Strip Strip
1. Test time
Test time of Blood Glucometer in each case is 10 seconds.
2. Test range
Test range of Blood Glucometer is 1.1mmol/L～33.3mmol/L
3. Measurement repeatability of Blood Glucometer and Blood Glucose Test
Strip
Precision of the repeated test results of Blood Glucometer and Blood
Glucose Test Strip should comply with the requirements in Table 1.
Test Range
＜5.5mmol/L（<100mg/dL）
≥5.5 mmol/L（≥100 mg/dL）
4. System accuracy of Blood Glucometer and Blood Glucose Test Strip
For Blood Glucometer and Blood Glucose Test Strip, 95% of the deviation of
the test results should comply with the requirements in Table 2:
Test Range
≤4.2mmol／L(<75mg／dL)
＞4.2mmol／L(>75mg／dL)
Blood Blood Glucometer Glucometer
Blood Glucometer Glucometer and
Table 1 Repeatability
Standard deviation SD＜0.42 mmol/L（ <7.7 mg/dL）
Coefficient of variation CV＜7.5%
Table 2 Accuracy
Allowable deviation
Not more than ±0.83mmol／L(±15mg／dL)
Not more than ±20％
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and and Blood Blood Glucose Glucose
and Blood Blood Glucose Glucose
Precision