FDA Clears ACON's OTC, Home COVID-19 Antigen Test
By Sam Brusco, Associate Editor | 11.10.23
The Flowflex test is the second home COVID-19 test to complete the traditional FDA premarket review pathway.
The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the first over-the-counter (OTC) antigen test for COVID-19.
ACON Laboratories’ Flowflex COVID-19 antigen home test was originally authorized for emergency use in 2021 and is now the second home COVID-19 test to complete the traditional FDA premarket review pathway, as well as the first indicated for use in children under 18.
“This marks the latest step forward in our efforts to help test developers provide Americans with continued options for safe and effective COVID tests that can be performed entirely at home,” Jeff Shuren, MD, J.D., director of the FDA’s Center for Devices and Radiological Health, told the press. “The FDA continues to proactively work with test developers that desire to market their products beyond emergency use authorities. This is part of the FDA’s broader effort to advance the development and availability of at-home tests for a variety of medical conditions to expand patient access to testing.”
The Flowflex test is a visually-read test cleared for OTC home use for symptomatic people within six days of the onset of symptoms. It’s cleared for self-testing for people 14 and up, or adults testing people age two and older.
Citing an FDA-reviewed study, the agency said the Flowflex test correctly identified 89.8% of positive and 99.3% of negative samples in individuals with signs and symptoms of upper respiratory infection.
ACON Laboratories’ Flowflex COVID-19 antigen home test was originally authorized for emergency use in 2021 and is now the second home COVID-19 test to complete the traditional FDA premarket review pathway, as well as the first indicated for use in children under 18.
“This marks the latest step forward in our efforts to help test developers provide Americans with continued options for safe and effective COVID tests that can be performed entirely at home,” Jeff Shuren, MD, J.D., director of the FDA’s Center for Devices and Radiological Health, told the press. “The FDA continues to proactively work with test developers that desire to market their products beyond emergency use authorities. This is part of the FDA’s broader effort to advance the development and availability of at-home tests for a variety of medical conditions to expand patient access to testing.”
The Flowflex test is a visually-read test cleared for OTC home use for symptomatic people within six days of the onset of symptoms. It’s cleared for self-testing for people 14 and up, or adults testing people age two and older.
Citing an FDA-reviewed study, the agency said the Flowflex test correctly identified 89.8% of positive and 99.3% of negative samples in individuals with signs and symptoms of upper respiratory infection.
