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Data for Study Devices vs. Predicate not within allowable ranges.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Obtain CLIA Waiver Status for the Quo-Test | 10 Days |
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Inclusion Criteria:
Exlcusion Criteria:
• Declines participation or withdraws before study completion
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From site's patient database
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| Name | Affiliation | Role |
|---|---|---|
| Tim Bailey, MD | AMCR Institute | Principal Investigator |
| Stephanie Svoboda, PharmD | Ridgeview Research | Principal Investigator |
| Michael Gardner, MD | University of Missouri-Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AMCR Institute | Escondido | California | 92026 | United States | ||
| Ridgeview Research |
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Whole Blood Venous Draw and Capillary Blood - IVD Study
| Chaska |
| Minnesota |
| 55318 |
| United States |
| University of Missouri | Columbia | Missouri | 65212 | United States |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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