NEW YORK – South Korean diagnostic firm Osang Healthcare has confirmed it received 510(k) clearance from the US Food and Drug Administration for two COVID-19 and influenza combination antigen tests.
The QuickFinder COVID-19/Flu Antigen Self-Test and the QuickFinder COVID-19/Flu Antigen Pro Test detect SARS-CoV-2, influenza A, and influenza B in swab specimens and provide results within 15 minutes. Clinical research organization CovarsaDx conducted studies to support the FDA clearance, the CRO said in a statement.
The self-test is intended for home use by people 14 years or older testing themselves or by adults testing patients ages 2 to 13. The pro test is intended for professional use in healthcare settings.
The self-test received Emergency Use Authorization from the FDA in April.