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BioFire submits FilmArray GI panel to FDA for 510(k) clearance

BioFire Diagnostics has submitted the FilmArray Gastrointestinal (GI) Panel to the US Food and Drug Administration (FDA) for 510(k) clearance, following successful completion of a clinical study that included more than 1,500 prospective samples.

According to the company, the study was conducted at several hospital-based clinical laboratories in the US.

The comprehensive 23-target panel tests for common bacteria, viruses and parasites that cause infectious diarrhea. The test is performed in about an hour directly from stool in transport media.

BioFire plans to launch the GI panel in the second half of 2014 in both the US and Europe.

Despite advances in food safety, sanitation and medical treatment, infectious gastroenteritis remains a significant problem in industrialized countries among all age groups.

In the US, around 76 million cases of foodborne disease – resulting in 325,000 hospitalizations and 5,000 deaths – are estimated to occur each year.

BioFire Diagnostics CEO Randy Rasmussen said the company is thrilled to submit its GI Panel to the FDA and believe that this panel will deliver the rapid, comprehensive results that its customers need to aid in timely diagnosis of infectious diarrhea.

"This submission highlights our continued work to expand the menu of tests for our FilmArray platform," Rasmussen added.

Additionally, BioFire has initiated studies for its Meningitis Panel, with FDA submission expected in 2015.