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Multi-functional Monitoring Series

Safe AQ UG

Bi-functional blood glucose and uric acid monitoring system;  Automatic strips ejection; ISO15197 2013 approved;  Smart code for uric acid test

Overview

      The Safe AQ UG Blood Glucose and Uric Acid Monitoring System is designed for the quantitative measurement of glucose and uric acid in fresh capillary whole blood samples and in venous whole blood samples. The Safe AQ UG Blood Glucose and Uric Acid Monitoring System is for use outside the body only (in vitro diagnostic use) for self-testing and professional use as an aid in the management of diabetes and hyperuricemia (HUA).

Specification
Test FunctionBlood GlucoseUric Acid
Test methodFAD-GDHOxidized Ferrocene Derivative
Sample typePeripheral capillary whole blood/venous whole bloodPeripheral capillary whole  blood/venous whole blood
Blood sample
0.6µl3µl
Test range20-600mg/dL
 (1.1-33.3mmol/L)
3.0-20.0mg/dL
(181-1188 µmol/L)
Test time5s25s
Memory500 sets100 sets
Strip validity24 months12 months
◆ Blood glucose user performance evaluation:
Results for glucose concentrations<100 mg/dL (<5.55mmol/l)
Within ± 5mg/dL
(within ± 0.28mmol/l)
Within ± 10mg/dL
(within ± 0.56mmol/l)
Within ± 15mg/dL
(within ± 0.83mmol/l)
50%(14/28)85.71% (24/28)100% (28/28)
                Results for glucose concentrations ≥ 100 mg/dL (≥5.55mmol/l)
Within ± 5%
Within ± 10%
Within ± 15%
55.56%(40/72)90.28%(65/72)97.22%(70/72)
◆ Uric acid user performance evaluation:
Results for uric acid concentrations < 297μmol/L (5.0 mg/ dL)
Within ± 14.9μmol/L
(Within ± 0.3 mg/ dL)
Within ± 29.7μmol/L
(Within ± 0.5 mg/ dL)
Within ± 59.4μmol/L
(Within ± 1.0 mg/ dL)
40.0%(6/15)60.0% (9/15)100% (15/15)
                Results for uric acid concentrations≥ 297μmol/L (5.0 mg/ dL)
Within ± 5%
57.6%(49/85)
Within ± 10%
94.1%(80/85)
Within ± 15%
100%(85/85)





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