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The ALPCO Calprotectin Immunoturbidimetric Assay is an in-vitro diagnostic assay used for the quantitative measurement of human fecal calprotectin in human stool. The ALPCO Calprotectin Immunoturbidimetric Assay is intended for in-vitro diagnostic use as an aid in diagnosis of inflammatory bowel disease (IBD), specifically Crohn's disease (CD) and ulcerative colitis (UC), and as an aid in the differentiation of IBD from irritable bowel syndrome (IBS) in conjunction with other clinical and laboratory findings.

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I am sorry to inform you that the provided text does not contain detailed information about the acceptance criteria, specific study results, sample sizes for test and training sets, expert qualifications, or adjudication methods for the ALPCO Calprotectin Immunoturbidimetric Assay.

The text is primarily a 510(k) clearance letter from the FDA, confirming that the device is substantially equivalent to a legally marketed predicate device. It outlines the regulatory classification, general controls, and indications for use. While it states the intended use of the assay, it does not provide the specifics of the performance study that would establish achievement of acceptance criteria.

Therefore, I cannot generate the requested table and detailed description based on the provided input. To answer your questions, I would need a different document, likely a '510(k) Summary' or the full '510(k) Premarket Notification' submission, which typically contains the detailed performance data.

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