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OcuSense submits 510(k) premarket notification for TearLab Osmolarity System

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TORONTO — Occulogix subsidiary OcuSense has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration for clearance to market its TearLab Osmolarity System and the TearLab Osmolarity Test Card in the United States, according to a press release from Occulogix.

The application included a study that evaluated the usability, safety and clinical performance of the system using tear fluid collected from 234 volunteer patients at three sites, the release said.

OcuSense expects to release data from the study at the American Academy of Ophthalmology and European Society of Ophthalmology joint meeting in November.

The TearLab Osmolarity System's "lab-on-a-chip" approach requires less than 50 nL of tear fluid to measure tear osmolarity, which eliminates the challenges that previously prevented point-of-care osmolarity testing.

The device recently obtained CE Mark Certification and is currently available for purchase in five European countries through exclusive distributor agreements. Pending 510(k) clearance, the system is available in the United States for research use only.