LumiraDx Submits First 510(k) Application to the FDA for COVID Ultra Test

LumiraDx submits a traditional 510(k) 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 (Ag) Ultra test, and the LumiraDx SARS-CoV-2 Ag Quality Control Swab Kit.

LONDON, June 30, 2023 (GLOBE NEWSWIRE) -- LumiraDx Limited (Nasdaq: LMDX), a leading innovator in diagnostic technologies, today announced the submission of its first 510(k) application to the U.S. Food and Drug Administration (FDA) for the clearance of its ground-breaking 5-minute COVID Ultra Test. LumiraDx submitted a traditional 510(k) 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 (Ag) 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 (EUA) for its SARS-CoV-2 Ag tests during the pandemic. This is the first time the LumiraDx Instrument has been submitted for 510(k) 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.

The LumiraDx SARS-CoV-2 Ag Ultra Test is a state-of-the-art diagnostic test that leverages LumiraDx's cutting-edge technology to detect the presence of SARS-CoV-2, the virus responsible for COVID-19. Built upon a robust scientific foundation, the test demonstrates exceptional accuracy and reliability, ensuring confidence in its results. The test is already available in Europe and various international markets.

"We are thrilled to announce the submission of our first 510(k) application to the FDA for the clearance of our COVID Ultra Test," said Carol Adiletto-Francis, Global SVP, Clinical Regulatory & Quality at LumiraDx. "LumiraDx remains committed to delivering innovative diagnostic solutions that address critical healthcare needs. The submission of this first 510(k) application represents a significant milestone in the company's journey towards receiving FDA approval for the COVID Ultra Test. This also forms the foundation for additional submissions of other high performing assays on the same Platform, many of which are available in Europe and elsewhere and others which are in late stages of development.”