Y330 Blood Glucose Test Strips
• Model: Y330 (50-count pack)
• Test Method: Glucose Oxidase
• Compatible Glucose Meter: Yuwell 582
• Sample Type: Fresh capillary whole blood from the fingertip
• Sample Volume: 1.0 μL
• Intended Users: People with diabetes and general users
• Storage Temperature: 4°C–30°C
• Storage Humidity: 10%–85% RH
• Operating Environment: 5°C–40°C; 10%–85% RH
• Clinical Sample Size: 120 cases
• Self-test sample size: 100 cases
• HCT range: 30%–60%
• Accuracy standard: Complies with EN ISO 15197:2015
• Consensus Error Grid (CEG): 100% of data falls within Zone A
• Correlation coefficient (R): 0.9942–0.9948
• No reports of adverse events or device defects
“Yuwell Blood Glucose Test Strips” are used for the quantitative measurement of glucose concentration in fresh capillary whole blood from the fingertip and ,
are designed for use with the Yuwell 582 blood glucose meter.
The product utilizes the glucose oxidase (GOD) detection principle and is suitable for daily blood glucose monitoring by people with diabetes as well as blood glucose testing in medical institutions.
Clinical studies were conducted at the Second Affiliated Hospital of Nanjing Medical University,
and the results showed that the product meets the accuracy requirements for blood glucose monitoring systems specified in EN ISO 15197:2015.
Study report: Clinical performance study report (Eng)