BÜHLMANN fCAL® ELISA, an in vitro diagnostic assay intended for the quantitation of calprotectin in human stool, has received 510(k) clearance from the Food and Drug Administration (FDA) and is now commercially available in the US.
Amherst, NH, 2018: BÜHLMANN Laboratories AG, is proud to announce it has received United States Food and Drug Administration (FDA) 510(k) clearance of its BÜHLMANN fCAL® ELISA. The BÜHLMANN fCAL® ELISA is an in vitro diagnostic assay intended for the quantitative measurement of fecal calprotectin in human stool. The BÜHLMANN fCAL® ELISA aids in the diagnosis of inflammatory bowel disease (IBD), specifically Crohn’s disease (CD) and ulcerative colitis (UC) and aids in the differentiation of IBD from irritable bowel syndrome (IBS) in conjunction with other laboratory and clinical findings.
Due to the high prevalence of gastrointestinal disease and challenges of current treatment pathways, the use of a non-invasive inflammation bio-marker such as calprotectin is essential in helping physicians evaluate patients in a timely manner. The use of a biomarker for patient care demands that the test be accurate and reproducible over long periods of time – one of the key characteristics of the BÜHLMANN fCAL® ELISA assay.
KT Park, MD, MS, Chair of Clinical Care and Quality, NASPGHAN and Co-Director, Stanford Children’s IBD Center at Stanford University School of Medicine stated, “Screening fecal calprotectin prior to diagnostic endoscopy is a cost-effective approach to differentiate IBS versus IBD. The growing body of research — especially in the area of IBD — will continue to inform clinical practice and reliance on noninvasive biomarkers. I am mindful of the numerous correlation and validation studies already published using the BÜHLMANN fCAL® ELISA. When considering the recent FDA clearance of BÜHLMANN’s calprotectin in the U.S., assay reliability and precision data are important considerations. And expanding the marketplace of calprotectin with high-quality assay options should enhance patient care.”
In a multi-site clinical study, the BÜHLMANN fCAL® ELISA, which has excellent precision and reproducibility, was demonstrated to be a a valuable diagnostic aid in the diagnosis of IBD and in the discrimination between IBD and IBS.