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The SPOTCHEM II Total Bilirubin test is intended to measure the levels of bilirubin in serum, plasma, and whole blood. Measurements of the levels of bilirubin are used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

The SPOTCHEM II Total Protein test is intended to measure total protein in serum, plasma, and whole blood. Measurements of total protein are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow, as well as other metabolic and nutritional disorders.

The SPOTCHEM II Albumin test is intended to measure the albumin concentration in serum, plasma, and whole blood. Measurements of albumin are used in the diagnosis and treatment of numerous diseases involving the liver or kidneys.

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This document is a 510(k) clearance letter from the FDA for Arkray SPOTCHEM II Total Bilirubin, Total Protein, and Albumin Tests. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information regarding acceptance criteria, study details, device performance, sample sizes, ground truth establishment, or expert involvement. These details would typically be found in the 510(k) submission itself, or in supporting documentation, which is not included in the provided snippets.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input. The document is solely a regulatory clearance for marketing the device.

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