Calprotectin Test Earns 510(k) Clearance

ALPCO has received 510(k) clearance from the FDA for its new fecal Calprotectin chemiluminescence ELISA test.

The stool test is the latest addition to the company’s Stellux product portfolio. Its accuracy enables gastroenterologists to differentiate inflammatory bowel disease (IBD) from irritable bowel syndrome (IBS).

Calprotectin is a non-invasive biomarker for identifying inflammation in the gastrointestinal tract associated with IBD. Many patients with IBD have symptoms similar to IBS which can cause a delay in receiving the correct diagnosis.