OccuLogix Submits Premarket Notification for Tearlab Osmolarity System
OccuLogix, a provider of ophthalmic devices, has announced that its subsidiary, OcuSense has submitted its 510(k) premarket notification to the FDA for clearance to market the TearLab osmolarity system and the TearLab osmolarity test card in the US.
The regulatory application included a study that validated the performance of the TearLab osmolarity system when performed in physician office laboratories by health care professionals using human tear fluid collected from volunteer subjects.
Eric Donsky, CEO of OccuLogix, said: “We are pleased to reach this significant milestone. We are looking forward to the FDA review of our submission and the opportunity to provide eye care practitioners with the ability to use quantitative physiological data at the point of care with the TearLab osmolarity system.”
Benjamin Sullivan, chief scientific officer of OccuLogix, said: “The TearLab system has been shown to eliminate the effects of evaporation and sample transfers on nanoliter osmolarity measurements. The TearLab system allows lab technicians to obtain the quantitative measurement of tear osmolarity, and the speed of the test lets it integrate seamlessly into the clinical workflow.”