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The KRONUS 21-Hydroxylase Antibody (21-OHAb) RIA Assay Kit is for the semiquantitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum. The KRONUS Steroid 21-OHAb RIA Assay may be useful as an aid in the diagnosis of autoimmune adrenal disease, whether expressed as autoimmune Addison's disease (isolated) or Addison's disease as part of the more complex autoimmune polyglandular syndrome (APS), type I or II. The assay result is to be used in conjunction with other clinical and laboratory findings and is not a substitute for functional testing required to diagnose adrenal insufficiency.

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The provided document describes a 510(k) premarket notification for a medical device, specifically the KRONUS Steroid 21-Hydroxylase Antibody (21-OHAb) RIA Assay Kit. It establishes substantial equivalence to a predicate device, but does not contain the information required to answer your specific questions about acceptance criteria and proof of performance through a study.

The document is a regulatory approval letter from the FDA, confirming that the device can be marketed. It details the device name, regulation number, regulatory class, product code, and indications for use. Key information like sample sizes, ground truth establishment, expert qualifications, and detailed study results are typically found in the submission itself, which is not provided here.

Therefore, I cannot provide the requested information based solely on the text you've given me. To answer your questions, I would need access to the actual 510(k) submission data, specifically the sections that detail the validation studies and performance data.

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