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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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The ALPCO Calprotectin Chemiluminescence ELISA is an in vitro diagnostic chemiluminescent assay intended for the quantitative measurement of fecal calprotectin, a neutrophilic protein that is a marker of intestinal mucosal inflammation, in human stool. The ALPCO Calprotectin Chemiluminescence ELISA is intended for in vitro diagnostic use as an aid in the 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.

The ALPCO Easy Stool Extraction Device is intended for use in the preparation of human stool specimens for testing in the ALPCO Calprotectin Chemiluminescence ELISA.

The ALPCO Calprotectin Chemiluminescence ELISA is performed on stool samples, collected without preservatives. After an extraction procedure of the stool sample, using either the manual weighing or Easy Extraction Device procedure, the test allows the selective measurement of calprotectin-antigen by sandwich ELISA. A monoclonal capture antibody (mAb) highly specific to the calprotectin heterodimeric and polymeric complexes, respectively, is coated onto the microtiter plate. Calibrators, controls and specimen extracts are incubated. After a washing step, a biotinylated secondary monoclonal detection antibody detects the calprotectin molecules bound to the antibody coated onto the plate. After incubation and a further washing step, a Streptavidin-Horseradish Peroxidase Enzyme conjugate binds to the available biotin on the immobilized secondary antibody. A chemiluminescent substrate is added and read when the substrate glows as a result of its oxidation with the enzyme. The signal is then read on a chemiluminescent plate reader.

Here's an analysis of the acceptance criteria and study detailed in the provided text for the ALPCO Calprotectin Chemiluminescence ELISA and ALPCO Easy Stool Extraction Device:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" for all performance aspects in a unified table. However, based on the narrative, acceptance implies successful demonstration of performance within established guidelines (e.g., CLSI standards) and acceptable ranges. Here's a table summarizing the performance evaluation and implied acceptance:

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