CardioGenics plans to file 510(k) application with the US Food and Drug Administration (FDA) for its QL Care Analyzer (QLCA), by collecting data from the testing at 4 hospitals in North America.
The 510K application will allow the FDA to determine whether the QLCA is equivalent to another device that is currently approved by the FDA for commercialization and with the approval CardioGenics will begin marketing the QLCA throughout the US.
The company has determined that it will use the Siemens ADVIA Centaur Analyzer and its related Troponin-I test as the reference standard for its clinical testing.
CardioGenics expects to begin enrolling patients in the comparative trial upon approval of the Institutional Review Boards, which is expected to receive by May 2011, and the trials are expected to complete in 45days.
Upon successful completion of clinical confirmation, the company will then finalize protocols and commence trials for the FDA application for approval of its QL Care Analyzer and Troponin-I test.
The final testing is expected to start during early Q3 2011 and complete two months later.