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
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 360
- 试验地点
- 3
- 主要终点
- The objective is to conduct reproducibility testing using duplicates of each of 3 levels of HbA1C
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
The objective is to conduct reproducibility testing using duplicates of each of 3 levels of HbA1C
时间窗: 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.
次要结局
- Obtain CLIA Waiver Status for the Quo-Test(10 Days)