NEW YORK (360Dx) – TearLab today announced it has submitted a 510(k) application to the US Food and Drug Administration for its TearLab Discovery Platform, an in vitro diagnostic testing system for ophthalmic conditions.
The submission also covers a test card measuring the inflammatory biomarker MMP-9, TearLab said, adding the TearLab Discovery platform will be able to perform its current FDA-cleared tear osmolarity test.
The company said 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. The firm noted that its MMP-9 predicate device and the current TearLab osmolarity test have existing CLIA Waivers to allow POC testing. In the meantime, it will continue to build the clinical data package for the commercial launch of the TearLab Discovery Platform, pending possible FDA clearance and CLIA waiver.
TearLab Discovery, a lab-on-a-chip platform received CE marking in July. It allows for the evaluation of multiple biomarkers in human tears with a single nanoliter volume tear collection.