First OTC Rapid Antigen Test for COVID-19 Cleared By FDA
The test is also the first OTC rapid antigen test cleared for any infectious disease.
The FDA has cleared for marketing the first OTC rapid antigen test for COVID-19, the Flowflex COVID-19 Antigen Home Test, manufactured by ACON Laboratories, according to an agency news release.1,2
The test was initially granted emergency use authorization in 2021 as a nasal swab test, and is now the second at-home COVID-19 test to successfully complete the traditional FDA premarket review pathway, according to an agency news release. The Flowflex COVID-19 Antigen Home Test is also the first indicated for use in children under age 18.
The test is intended for use by individuals demonstrating COVID-19 symptoms, within 6 days of symptom onset. Adolescents aged 14 years and older may use the test themselves; children between 2 and 13 years of age should be tested by an adult.
“This marks the latest step forward in our efforts to help test developers provide Americans with continued options for safe and effective COVID-19 tests that can be performed entirely at home,” said Jeff Shuren, MD, JD, director of the FDA Center for Devices and Radiological Health. “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,” Shuren added.
The test should be used at least twice over a 3-day period, with at least 48 hours between tests. An initial negative test should be followed by retesting between 48 and 72 hours of the first test.
“We are pleased to receive the first FDA 510(k) for an OTC COVID-19 antigen test,” said Michael Lynch, vice president of sales and marketing at Acon Labs, which manufactures the test. Flexflow is also the first OTC rapid antigen test for any infectious disease. “We believe this represents the FDA’s commitment to empowering people to take greater charge of their health care.”
According to the manufacturer, distribution of the 510(k) cleared test will begin in 2024.
References
FDA clears first COVID-19 home antigen test. News release. FDA. November 9, 2023. Accessed November 13, 2023. https://www.fda.gov/news-events/press-announcements/fda-clears-first-covid-19-home-antigen-test
Acon receives FDA 510(k) clearance for Flowflex COVID-19 test; will be manufactured in San Diego. News release. Acon Labs. November 9, 2023. Accessed November 13, 2023. https://www.aconlabs.com/acon-receives-fda-510k-clearance-for-flowflex-covid-19-test-will-be-manufactured-in-san-diego/
