Diagnostics news: Occulogix submits 510(k) for TearLab
OccuLogix Submits 510(k) Premarket Notification for the Tearlab(TM) Osmolarity System
OccuLogix, Inc. (NASDAQ: OCCXD)(TSX: OC) announced today that its subsidiary, OcuSense, Inc., has submitted its 510(k) premarket notification to the US Food and Drug Administration (the FDA) for clearance to market the TearLab(TM) Osmolarity System and the TearLab(TM) Osmolarity Test Card in the United States.
As previously disclosed, the TearLab(TM) system recently obtained CE Marking and is currently being sold and marketed in five European countries through exclusive distributor agreements. In the United States, prior to 510(k) clearance from the FDA, the system is available for research use only.
The regulatory application included a study that validated the performance of the TearLab(TM) Osmolarity System when performed in physician office laboratories (POL) by health care professionals using human tear fluid collected from volunteer subjects. The study looked at:
- Clinical performance
The study involved three sites and enrolled 234 patients. The Company expects to release top-line data from the study at the American Academy of Ophthalmology (AAO) and European Society of Ophthalmology (SOE) 2008 Joint Meeting in November.