BÜHLMANN CALEX® Cap, a single use tube intended for the preparation of human stool samples to be used with the BÜHLMANN fCAL® turbo, has received 510(k) clearance from the Food and Drug Administration (FDA) and is now commercially available in the US.
Amherst NH, 2019: BÜHLMANN Laboratories AG, is proud to announce it received United States Food and Drug Administration (FDA) 510(k) clearance of a fecal extraction device for use in conjunction with the automated calprotectin test, BÜHLMANN fCAL® turbo. The BÜHLMANN fCAL® turbo is an in vitro diagnostic assay intended for the quantitative measurement of fecal calprotectin, a neutrophilic protein that is a marker of intestinal mucosal inflammation, in human stool. The BÜHLMANN fCAL® turbo 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.
The fecal extraction device provides excellent correlation to the traditional manual weighing method and offers efficient, convenient and hygienic extraction of stool samples. The optimized stool sample dilution yields maximum extraction efficiency while delivering extract stability for 3.5 days at 2-8°C. Its unique design makes CALEX® Cap compatible with Total Laboratory Automation (TLA) solutions, minimizing the complexity of sample processing thus significantly reducing hands-on time. Combined with BÜHLMANN fCAL®turbo, CALEX® Cap revolutionizes calprotectin pre-analytics and enables workflow optimization through full automation. CALEX® Cap fecal extraction device is the first and only stool extraction device suitable for safe air and land transportation according to IATA 650 (UN3373) regulations.
Doug Olson, CEO of BUHLMANN Diagnostics Corp commented, “We are very excited to launch this unique, reliable fecal extraction device to help meet the increasing demand on laboratories for calprotectin testing. This clearance comes at a great time as we prepare for the launch of the BÜHLMANN fPELA® turbo, a turbidimetric assay for fecal pancreatic elastase. The CALEX® Cap will help to improve the efficiency of extraction, streamline workflow, and together with BÜHLMANN fCAL® turbo and BÜHLMANN fPELA® turbo, transform analysis of stool samples in clinical routines.”
Visit www.buhlmannlabs.com to learn more about this fecal extraction device.
About BÜHLMANN Calprotectin Product Line
The calprotectin portfolio consists of the BÜHLMANN fCAL® ELISA (FDA 510(k) cleared), BÜHLMANN fCAL® turbo (FDA 510(k) cleared) for testing on most clinical chemistry analyzers, Quantum Blue® fCAL Rapid Test (RUO in the US), and IBDoc®, the first and only Health Canada Licensed home-testing application for fecal calprotectin in IBD patients (IBDoc® not available for sale in the US).
About BÜHLMANN Laboratories AG
Founded in 1976, BÜHLMANN Laboratories AG has continued to focus on growing a product portfolio of in vitro diagnostics and research markets. BÜHLMANN is known for outstanding product quality, providing excellent after-sales services, and delivering remarkable scientific innovations. BÜHLMANN offers the broadest range of calprotectin products as well as a selection of unique, high-quality assays such as the BÜHLMANN Flow CAST® product group for Basophil Activation Testing, the BÜHLMANN GanglioCombi™ products for neuroimmunology, and a variety of Melatonin Assays.
About BUHLMANN Diagnostics Corp (BDC)
BUHLMANN Diagnostics Corp (BDC) is the North American affiliate of BÜHLMANN Laboratories AG, the worldwide provider of ELISA kits, RIA kits, lateral flow and flow cytometry assays. Located in Southern New Hampshire, BDC has a highly experienced team who represent a breadth of experience in serving both clinical and basic science research laboratories.