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The EasyRA Glucose Trinder (GLU-T) Reagent is for the measurement of glucose in serum and plasma using the "EasyRA chemistry analyzer". Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and pancreatic islet cell carcinoma. . For in vitro diagnostic use only. The EasyRA Glucose Hexokinase (GLU-H) Reagent is for the measurement of glucose in serum and plasma using the "EasyRA chemistry analyzer". Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and pancreatic islet cell carcinoma. . For in vitro diagnostic use only.

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I apologize, but the provided text from the FDA 510(k) summary for the EasyRA Glucose-Trinder Reagent and EasyRA Glucose-Hexokinase Reagent does not contain the acceptance criteria or a study describing the device's performance against such criteria.

The 510(k) document is a premarket notification that demonstrates substantial equivalence to a legally marketed predicate device. It typically focuses on the device's intended use, technological characteristics, and comparison to a predicate. While performance data is usually submitted as part of the 510(k) application, the publicly available summary often omits detailed study results, acceptance criteria, sample sizes, and ground truth information.

Therefore, I cannot provide the requested information based on the given text. To obtain that detail, one would typically need to refer to the full 510(k) submission document, if it were publicly accessible, or the device's official labeling, instructions for use, or a peer-reviewed publication that describes the validation studies.

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