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This product is to be used for the quantitative determination of glucose oxidase in human serum. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia and of pancreatic islet cell carcinoma. This reagent set is intended for in vitro diagnostic use only.

This product is to be used for the quantitative determination of hemoglobin A 1 c in human blood. The determination of hemoglobin A 1c is most commonly performed for the evaluation of glycemic control in diabetes. Hemoglobin A 1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher hemoglobin A 1c value indicates poorer glycemic control. This reagent set is intended for in vitro diagnostic use only.

This product is to be used for the quantitative determination of fructosamine in human serum. The determination of fructosamine is most commonly performed for the evaluation of glycemic control in diabetes. Fructosamine values provide an indication of glucose levels over the preceding 2-3 weeks. A higher fructosamine value indicates poorer glycemic control. This reagent set is intended for in vitro diagnostic use only.

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I am sorry, but the provided text is a 510(k) summary from the FDA, which is a regulatory document and does not contain the specific information requested about acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment. This document primarily outlines the substantial equivalence determination for the JAS Diagnostics Fructosamine, Glucose Oxidase, and Hemoglobin A1c test kits to legally marketed predicate devices.

Therefore, I cannot extract the information required to fill out the table and answer the questions.

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