This is a brief overview of information related to FDA’s clearance to market this product.
Product Name: PhiCal™ Fecal Calprotectin Immunoassay
Applicant Company: Genova Diagnostics, Inc.
Applicant Address: 63 Zillicoa Street, Ashville, NC 28801
Clearance Date: April 26, 2006
Clearance Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf5/k050007.pdf
What is it? The PhiCal™ Fecal Calprotectin Immnoassay is a lab test that measures the amount of fecal calprotectin 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.
How does it work?
- A stool sample is collected from the patient and added to chemicals in the PhiCal™ Fecal Calprotectin test to separate the fecal calprotectin from other stool components.
- The separated fecal calprotectin solution is mixed with other chemicals.
- When a specific chemical is added, a color reaction is produced and is measured inside an instrument.
- The amount of color produced shows the level of fecal calprotectin in the stool sample.
- The more fecal calprotectin in the sample, the more likely the patient has inflammatory bowel disease.
When is it used? The PhiCal™ Fecal Calprotectin Immunoassay is used when a patient shows symptoms of inflammatory bowel disease, where damage to the intestines may cause white blood cells to be present in the stool sample. Other types of intestinal diseases show similar symptoms but white blood cells are not present. This lab test may help a doctor identify which intestinal disease the patient has and prescribe appropriate treatment.
What will it accomplish? The PhiCal™ Fecal Calprotectin Immunoassay may help a doctor identify whether a patient has inflammatory bowel disease, and to distinguish inflammatory bowel disease from other intestinal diseases.
When should it not be used? There are no contraindications for this device.
510(k) Decision Summary and labeling will be available at: http://www.accessdata.fda.gov/cdrh_docs/pdf5/k050007.pdf