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.
Study Type
OBSERVATIONAL
Enrollment
360
AMCR Institute
Escondido, California, United States
Ridgeview Research
Chaska, Minnesota, United States
University of Missouri
Columbia, Missouri, United States
The objective is to conduct reproducibility testing using duplicates of each of 3 levels of HbA1C
The objective is to conduct a method comparison between both the Quo-Test and Quo-Lab investigational devices and the reference method \[Tosoh G8 (K071132)\]. The reference method also serves as the predicate for the premarket notifications for both investigational devices. Both capillary and venous samples will be tested on the Quo-Test A1C System and Quo-Lab A1C Test, while only venous samples will be tested on the reference method.
Time frame: 10 Days
Obtain CLIA Waiver Status for the Quo-Test
Time frame: 10 Days
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