TearLab Corporation announced that the U.S. Food and Drug Administration (FDA) has determined that the TearLab Discovery MMP-9 test, has not met the criteria for substantial equivalence based upon data and information submitted by TearLab in its 510(k) submission. The TearLab Discovery platform is designed to enable eye care professionals to assess multiple biomarkers in human tears with nanoliter volume tear collection. The lab-on-a-chip platform allows for the measurement of tear proteins in a fully automated workflow that is consistent with the currently marketed TearLab Osmolarity System, widely being utilized by physicians in their practice. The MMP-9 test card will aid in the diagnosis of dry eye disease.