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FDA Shoots Down Clear TearLab Dry-Eye Test for 510(k) Clearance

October 12, 2018

The FDA determined that the 510(k) application for Clear TearLab’s point-of-care TearLab Discovery MMP-9 test did not pass its criteria and the agency declined to clear it.

The platform is designed to allow eyecare professionals to analyze multiple biomarkers contained in human tears with nanoliter-volume collection.

The agency said that the dry-eye test did not adequately demonstrate substantial equivalence based on the data and information provided.

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