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The KRONUS Acetylcholine Receptor Antibody (AChRAb) Assay Kit is for the quantitative or qualitative determination of acetylcholine receptor antibody in human serum. The KRONUS Acetylcholine Receptor Antibody(AChRAb) kit is useful as an aid in the differential diagnosis of Myasthenia Gravis.

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The provided K042248 document is a 510(k) clearance letter from the FDA for the Kronus I125 Acetylcholine Receptor Antibody Kit. This document does not contain the detailed study information, acceptance criteria, or performance data that would be used to prove the device meets acceptance criteria.

FDA 510(k) clearance letters primarily state that the device is substantially equivalent to a legally marketed predicate device and outline the regulatory classification and general controls. They typically do not include the raw data, study design, or performance metrics from the studies submitted in the 510(k) application itself.

Therefore, based solely on the provided text, I cannot extract the information required to populate the requested table and answer the study-related questions.

To answer your request, I would need access to the full 510(k) submission document or a summary of the performance data that was provided to the FDA by Kronus Market Development Associates.

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