FDAnews Device Daily Bulletin

FDA UPDATES PHICAL FECAL CALPROTECTIN IMMUNOASSAY OVERVIEW

June 2, 2006
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The FDA has updated its information overview of the PhiCal fecal calprotectin immunoassay, a diagnostic test for inflammatory bowel disease.

The product is manufactured by Genova Diagnostics of Asheville, N.C., and was approved by the FDA April 26.

The PhiCal is a lab test that measures the amount of fecal calprotectin, evident in the number of white blood cells, in a patient's stool sample. High levels of fecal calprotectin may be an indication of inflammatory bowel disease (IBD). Common forms of IBD include Crohn's disease and ulcerative colitis, two chronic diseases that cause inflammation of the intestines, the agency said.

The updated information can be viewed at http://www.fda.gov/cdrh/mda/docs/k050007.html (http://www.fda.gov/cdrh/mda/docs/k050007.html).