LumiraDx submits first 510k application to FDA for COVID Ultra Test

LumiraDx announced the submission of its first 510k application to the U.S. Food and Drug Administration for the clearance of its ground-breaking 5-minute COVID Ultra Test. LumiraDx submitted a traditional 510k Dual Submission for LumiraDx SARS-CoV-2 Ag Ultra with CLIA Waiver for the commercial distribution at point of care of the LumiraDx Platform, including the LumiraDx Instrument, with the LumiraDx SARS-CoV-2 Antigen Ultra test, and the LumiraDx SARS-CoV-2 Ag Quality Control Swab Kit. This significant milestone marks a crucial step forward in continued access and expansion into the United States for the LumiraDx Platform. LumiraDx had earlier received various Emergency Use Authorizations for its SARS-CoV-2 Ag tests during the pandemic. This is the first time the LumiraDx Instrument has been submitted for 510k review and the submission underscores LumiraDx’s continued commitment to providing a complete solution that meets the highest standards of performance and safety. Once reviewed, this submission should facilitate further submissions to the FDA with focus switching from the LumiraDx Instrument to assay components.