Regulatory Focus™ > News Articles > FDA Clears Gastroenteritis Diagnostic Device Through De Novo Pathway

FDA Clears Gastroenteritis Diagnostic Device Through De Novo Pathway

Posted 15 January 2013 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) has announced the clearance of a new diagnostic test it says is capable of simultaneously testing a sample to identify the presence of any of 11 causes of infectious gastroenteritis.

Infectious gastroenteritis is a condition FDA explained is marked by the inflammation of the intestines and stomach, and may be caused by viruses, bacteria or parasites. Some of the most common variants include infections caused by salmonella, shigella, E. coli, campylobacter, clostridium and the norovirus. Other, sometimes less common variants include enterotoxigenic E. coli (ETEC), shiga-like toxin producing E. coli (STEC), Rotavirus A, cryptosporidium and giarda.

The device, the XTag Gastrointerestinal Pathogen Panel (GPP), manufactured by Luminex, Inc of Austin, TX, was cleared through FDA's De Novo classification process, which allows novel devices to be cleared without requiring the submission of a premarket approval (PMA) application. Previously unapproved devices or ones without an approved predicate are generally presumed to be high-risk class III medical devices until proven otherwise, and the pathway is meant to bring low-risk, innovative products to market more quickly.

In a statement, regulators praised the device, saying it could help to investigate outbreaks of gastroenteritis more quickly and with fewer required tests.

"The test could also allow clinicians and public health professionals to more quickly identify and investigate the source of potential gastroenteritis outbreaks," said Alberto Gutierrez, director of the Office of In Vitro Diagnostics (OIVD) and Radiology at the FDA's Center for Devices and Radiological Health (CDRH).

Regulators added that tests of the device showed it to be "comparable" to individual tests, and that all positive results need to be confirmed by additional testing to rule out the possibility of a false positive result.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.