TearLab Corp. said the U.S. Food and Drug Administration rejected its TearLab Discovery MMP-9 test, which helps diagnose dry eye disease.
The FDA said the data in San Diego-based TearLab's 510(k) submission has not met the criteria for substantial equivalence.
"We will continue working with the FDA to provide additional data for a new MMP-9 submission and remain committed to securing its 510(k) clearance," TearLab CEO Seph Jensen said in a news release.