(393 days)
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.
§ 866.5180 Fecal calprotectin immunological test system.
(a)
Identification. A fecal calprotectin immunological test system is anin vitro diagnostic device that consists of reagents used to quantitatively measure, by immunochemical techniques, fecal calprotectin in human stool specimens. The device is intended forin vitro diagnostic use as an aid in the diagnosis of inflammatory bowel diseases (IBD), specifically Crohn's disease and ulcerative colitis, and as an aid in differentiation of IBD from irritable bowel syndrome.(b)
Classification. Class II (special controls). The special control for these devices is FDA's guidance document entitled “Class II Special Controls Guidance Document: Fecal Calprotectin Immunological Test Systems.” For the availability of this guidance document, see § 866.1(e).