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The EasyRA Glucose hexokinase (GLU-H) Reagent is for the measurement of glucose in serum 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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The provided text is a 510(k) summary for the EasyRA Glucose-Hexokinase Reagent. It is a regulatory document from the FDA, and it does not contain information about acceptance criteria, specific device performance beyond its intended use, or the details of a study with the information requested in your prompt.

Specifically, the document:

• States the device is for measuring glucose in serum using the "EasyRA chemistry analyzer" for diagnosing and treating carbohydrate metabolism disorders.
• Confirms its classification as a Class II device.
• Determines its substantial equivalence to legally marketed predicate devices.

However, it does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study details.
6. Standalone (algorithm-only) performance results.
7. Type of ground truth used.
8. Sample size for the training set.
9. How the ground truth for the training set was established.

This type of information would typically be found in a detailed study report or internal validation documents, which are not part of this 510(k) clearance letter.

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