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
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ClinicalTrials.gov Identifier: NCT01829061
(Data for Study Devices vs. Predicate not within allowable ranges.)
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.
The objective is to conduct reproducibility testing using duplicates of each of 3 levels of HbA1C [ Time Frame: 10 Days ]
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.
Secondary Outcome Measures
Obtain CLIA Waiver Status for the Quo-Test [ Time Frame: 10 Days ]
Biospecimen Retention: Samples Without DNA
Whole Blood Venous Draw and Capillary Blood - IVD Study
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
From site's patient database
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
• Declines participation or withdraws before study completion