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

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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.


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
sites
Columbia, Missouri 65211
(573) 882-2121
University of Missouri T he University of Missouri was founded in 1839 in Columbia, Mo.,...
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Columbia, MO
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3000 Hundertmark
Chaska, Minnesota 55318
952-556-2686
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Chaska, MN
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Escondido, California 92026
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Escondido, CA
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