CovarsaDx® Supports FDA 510(k) Clearance for OSANG’s QuickFinder™ COVID-19/Flu Tests
CovarsaDx®, a prominent Clinical Research Organization (CRO) renowned for its expertise in the areas of in-vitro diagnostics (IVDs) and medical devices, proudly announced today that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance for the QuickFinder™ COVID-19/Flu Antigen Self-Test (Self Test) and QuickFinder™ COVID-19/Flu Antigen Pro Test (Pro Test). CovarsaDx, on behalf of test manufacturer OSANG Healthcare, conducted key studies necessary to support the clearance.
These tests provide a solution for detecting SARS-CoV-2, influenza A, and influenza B antigens without a prescription using simple nasal swab specimens and provide results within 15 minutes.
“CovarsaDx’s clinical research expertise was instrumental in designing and executing the studies needed to validate the QuickFinder™ tests, ensuring they are safe, effective, and easy-to-use diagnostic tools,” said Dan Lee, CEO of OSANG Healthcare. “Working with this dedicated team was a seamless and collaborative experience, and their commitment to quality and precision was invaluable in achieving this milestone.”
The QuickFinder™ Self Test is indicated for home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged two years or older. With clear, step-by-step instructions, users of the test can identify COVID-19 and influenza respiratory infections, from the comfort of their homes. The QuickFinder™ Pro Test will be marketed for professional use in health care settings.
“Our clinical research team specializes in creating tailored, high-quality studies that provide the data necessary to navigate regulatory pathways successfully,” said Chermaen Lindberg, president and CEO of CovarsaDx. “We are proud to have partnered with OSANG Healthcare in bringing this consumer-friendly diagnostic tool to market.”
This achievement highlights CovarsaDx’s commitment to advancing diagnostic innovation through its specialized clinical research, regulatory and quality services, offering tailored solutions to accelerate product development and regulatory approval.
For more information about CovarsaDx and their clinical research services, visit https://covarsadx.com.