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FDA Declines to Clear TearLab Dry-Eye Test

NEW YORK (360Dx) – TearLab announced late on Wednesday that the US Food and Drug Administration has determined its point-of-care TearLab Discovery MMP-9 test failed to meet the criteria for substantial equivalence based on data and information in its 510(k) submission.

In order to get 510(k) clearance for a device, a company must show it is substantially equivalent to a similar device previously cleared by the FDA for marketing.

The TearLab Discovery lab-on-a-chip platform is designed to enable eye-care professionals to assess multiple biomarkers in human tears with nanoliter-volume collection. It allows for the measurement of tear proteins in a fully automated workflow that is consistent with its TearLab Osmolarity System, which is on the market and being used by physicians, the firm said. Its MMP-9 test card will aid in the diagnosis of dry-eye disease.

The firm previously announced it had submitted a 510(k) application to the FDA that covers its TearLab Discovery platform along with the test card, which measures the inflammatory biomarker MMP-9. TearLab Discovery received CE marking for the test in July 2017.

"We are working diligently to compile the additional information necessary to achieve a 510(k) clearance," TearLab's CEO Seph Jensen, said in a statement. "We understand the FDA's position and are encouraged by the clear guidance they have provided."

He said that the company will continue to work with the agency to provide additional data for a new regulatory filing for the test.

The Escondido, California-based firm said previously that it will file a CLIA waiver with the FDA if it receives 510(k) clearance for the system, which would allow it to be used at the point of care. Its MMP-9 predicate device and the current TearLab osmolarity test have existing CLIA waivers to allow POC testing.