FDA: TearLab ’ s Discovery MMP-9 test 510(k) fails to meet substantial equivalence

TearLab Corp. (OTC:TEAR) said this week that the FDA ruled that the company’s 510(k) submission for its TearLab Discovery MMP-9 test, designed to measure an inflammatory biomarker found in tears, did not meet criteria for substantial equivalence. The San Diego-based company’s TearLab Discovery lab-on-a-chip platform is intended to analyze multiple biomarkers in human tears with nanoliter volume tear collection. The MMP-9 test is intended to aid in the diagnosis of dry eye disease, the company added. Read the whole story on our sister site, Drug Delivery Business News  The post FDA: TearLab’s Discovery MMP-9 test 510(k) fails to meet substantial equivalence appeared first on MassDevice.
Source: Mass Device - Category: Medical Devices Authors: Tags: 510(k) Clinical Trials Diagnostics Food & Drug Administration (FDA) Regulatory/Compliance Tearlab Corp. Source Type: news