APPY1 regulatory update

Venaxis submitted a response to FDA’s request for information related to its 510(k) application for APPY1 to aid emergency room clinicians in identifying patients at low risk for appendicitis in individuals ages 2-20 years with abdominal pain. The company said the agency requested further clarification on the test’s labeling and intended use in an emergency setting as well as analytical data.

The company is seeking concurrent de novo classification of the test. FDA’s de novo pathway is an alternative path to market for devices that are lower risk and may not require a PMA but are of a new type and would not be cleared via the 510(k) pathway. ...