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FDA Clears Bühlmann Fecal Calprotectin Extraction Device

NEW YORK – Bühlmann Laboratories announced on Wednesday its Calex Cap fecal extraction device has received 510(k) clearance from the US Food and Drug Administration to be used with its fecal calprotectin test.

The device is compatible with total laboratory automation solutions and is fully automated. The Calex Cap keeps stool extracts stable for 3.5 days at 2 to 8 degrees Celsius. It's the only stool extraction device suitable for safe air and land transportation according to IATA 650 regulations, the company said in a statement.

Bühlmann's calprotectin test, the Fcal Turbo, is an in vitro diagnostic assay that measures fecal calprotectin, a protein that signifies intestinal mucosal inflammation. It can help clinicians diagnose Crohn's disease and ulcerative colitis and differentiate between inflammatory bowel disease and inflammatory bowel syndrome.

The Switzerland-based company also offers the FDA-cleared Fcal Elisa calprotectin test, along with the Quantum Blue Fcal test, which is for research use only in the US, and the IBDoc home test, which is not available in the US. Bühlmann is preparing to launch its Fpela Turbo test for fecal pancreatic elastase.