Sinocare TRUE METRIX AIR, Manual

Page: 67 / 78

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Table 2：Repeatability Requirement
Table 1: Accuracy Requirement
13. Performance
1.1mmol/L～5.55mmol/L
（20mg/dL～100mg/dL）
5.55mmol/L～33.3mmol/L
（100mg/dL～600mg/dL）
Within ±0.83mmol/L（±15mg/dL）
Within ±15%
Accept Bias Test Range
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.
1.1mmol/L～5.55mmol/L
（20mg/dL～100mg/dL）
SD＜0.34mmol/L（6 mg/dL）
Precision Test Range
CV＜6%
5.55mmol/L～33.3mmol/L
（100mg/dL～600mg/dL）