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FDA to issue waiver for TearLab Osmolarity System

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SAN DIEGO — The U.S. Food and Drug Administration has granted TearLab Corporation a waiver of Clinical Laboratory Improvement Amendment standards, allowing unfettered clinical access to the company's TearLab Osmolarity System, according to a news release from the company.

The waiver will be issued after the company submits labeling information deemed acceptable by the FDA, the release said.

"This marks the achievement of our third and final major milestone," Elias Vamvakas, TearLab's chief executive officer, said in the release. "We believe that in order for the TearLab Osmolarity System to become widely adopted, it is essential that it be accessible at the point of care. Now, with the CLIA waiver obstacle overcome, this groundbreaking test is free to start growing to its potential."

The TearLab Osmolarity System requires less than 50 nL of tear fluid to measure tear osmolarity, facilitating osmolarity testing at the point of care. The system can yield conclusive results in less than 30 seconds, according to the release.