23
10. Performance
Accuracy and repeatability criteria for this product is
refer to national standard GB/T19634-2005 In vitro diagnostic
test systems -General technical requirements for blood-glu-
cose monitoring systems for self-testing and International
standard EN ISO 15197:2015 In vitro diagnostic test systems
—Requirements for blood-glucose monitoring systems for
self-testing in managing diabetes mellitus.
Accuracy requirement: ≥95% of test result bias shall
meet table 1 requirement.
Repeatability requirement: test result shall meet table 2
requirement.
Table 1: Accuracy Requirement
1.10mmol/L～5.55mmol/L
（20mg/dL～100mg/dL）
5.55mmol/L～33.30mmol/L
（100mg/dL～600mg/dL）
Within ±0.83mmol/L（±15mg/dL）
Within ±15%
Accept Bias
Test Range
WARNING!
Out of range -
Low results <
1.1 mmol/L
WARNING! Retest
with new test strip. If
result is still “Lo”
(Low) contact doctor
or healthcare
professional
immediately.
Display
Reason
Action
