Diabetes
Conditions
Keywords
Type I Diabetes, Type II Diabetes, HbA1C
Brief summary
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.
Interventions
None listed
Sponsors
Quotient Diagnostics Limited
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The objective is to conduct reproducibility testing using duplicates of each of 3 levels of HbA1C | 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
| Measure | Time frame |
|---|---|
| Obtain CLIA Waiver Status for the Quo-Test | 10 Days |
Countries
United States
Outcome results
None listed