NEW YORK — Biomerica said on Tuesday that it has submitted a 510(k) premarket notification for its Hp+detect Helicobacter pylori test to the US Food and Drug Administration.
The Irvine, California-based company said that the FDA could decide whether to clear the test within 90 days of receiving the notification. A CE mark filing for the test is also being prepared, Biomerica said.
Hp+detect is designed to detect the presence of H. pylori, a key cause of gastric cancer and peptic ulcers.
"We're particularly excited about this product as it has shown to be highly accurate as compared to other products in the market," Biomerica Chairman and CEO Zack Irani said in a statement. "We've also created an efficient, low-cost manufacturing process that should enable high gross margins on this product."