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The KRONUS Blocking AChRAb RIA Assay Kit is for the semi-quantitative determination of blocking antibodies to the acetylcholine receptor in human serum. The KRONUS Blocking AChRAb Assay is useful as an aid in the diagnosis of myasthenia gravis (MG).

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The provided text is an FDA 510(k) clearance letter for the KRONUS I123 Acetylcholine Receptor Blocking Antibody Kit (KRONUS Blocking AChRAb RIA Assay Kit). This document focuses on the regulatory approval process and includes the device’s indications for use. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested table and information based directly on the given text.

The information you are requesting, such as acceptance criteria and detailed study results, would typically be found in the manufacturer's 510(k) submission document itself, or potentially in a more comprehensive summary document provided by the FDA, but not in the clearance letter.

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