Reproducibility and Method Comparison Studies of the Quo-Test™ A1C System and the Quo-Lab A1C Test and CLIA Waiver Study of the Quo-Test™ A1C System
Status: | Terminated |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | April 2013 |
End Date: | April 2014 |
Reproducibility and Method Comparison of the Quo-Test™ A1C System and the Quo-Lab A1C Test and CLIA Waiver of the Quo-Test™ A1C System
The Quo-Test A1C Analyzer and Reagent Test System (Quo-Test A1C System) are intended for the
in-vitro quantitative determination of glycated hemoglobin in whole blood samples obtained
from fingerstick or venous samples for point-of-care testing. The Quo-Test A1C System is
indicated in the management and treatment of diabetes and for monitoring long term glycemic
control by diabetics. It is for multiple patient use. Only auto-disabling, single use
lancing devices should be used with this system.
in-vitro quantitative determination of glycated hemoglobin in whole blood samples obtained
from fingerstick or venous samples for point-of-care testing. The Quo-Test A1C System is
indicated in the management and treatment of diabetes and for monitoring long term glycemic
control by diabetics. It is for multiple patient use. Only auto-disabling, single use
lancing devices should be used with this system.
Inclusion Criteria:
- Aged 18 years or over
- Able to read English
- Read, understood and signed the Informed Consent Form
- Agrees to participate and does not withdraw\
- Either healthy (without diabetes) or has Type 1 or Type 2 diabetes
Exlcusion Criteria:
• Declines participation or withdraws before study completion
We found this trial at
3
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University of Missouri T he University of Missouri was founded in 1839 in Columbia, Mo.,...
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