OraSure files 510(k) for drugs-of-abuse diagnostic:
This article was originally published in Clinica
Executive Summary
OraSure Technologies has filed a 510(k) application with the US FDA for permission to market its point-of-care oral fluid drugs-of-abuse diagnostic system. The UPlink reader has been submitted to the agency together with assays for detecting cocaine, opiates and amphetamines. The Bethlehem, Pennsylvania company plans to submit two additional tests - for marijuana and phencyclidine - within the next two months. The UPlink system is also being developed for gastrointestinal and respiratory infectious disease testing under an agreement with Meridian Diagnostics.