FDA approves first OTC rapid antigen test for COVID-19

The FDA has approved the marketing of the first OTC rapid antigen test for COVID-19, the Flowflex COVID-19 Antigen Home Test manufactured by ACON Laboratories, according to an FDA news release.1.2

The test, which originally received emergency use authorization in 2021 as a nasal swab test, is now the second at-home COVID-19 test to successfully complete the FDA’s traditional premarket review pathway, according to an agency news release. The Flowflex COVID-19 Antigen Home Test is also the first test available for children under 18 years of age.

This test is available to individuals who show symptoms of COVID-19 within 6 days of symptom onset. Teenagers ages 14 and older can use the test on their own; children ages 2 to 13 should be tested by an adult.

“This marks the latest step in our ongoing efforts to help test developers provide Americans with safe and effective COVID-19 testing options that can be administered entirely at home,” said Jeff Shuren, MD, JD, FDA center director. “Equipment and Radiological Health. “The FDA continues to actively work with test developers who wish to market their products outside of emergency use authorizations.”

“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 within 3 days, with at least 48 hours between tests. After an initial negative test, a retest should be performed within 48 to 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 for Acon Labs, which produces the test. Flexflow is also the first over-the-counter rapid antigen test for any infectious disease. “We believe this represents the FDA’s commitment to giving people more control over their health care.”

According to the manufacturer, distribution of the 510(k)-approved test will begin in 2024.

refer to
  1. FDA approves first COVID-19 home antigen test. Press Releases. U.S. Food and Drug Administration. November 9, 2023. Accessed 13 November 2023. https://www.fda.gov/news-events/press-announcements/fda-clears-first-covid-19-home-antigen-test
  2. Acon receives FDA 510(k) clearance for Flowflex COVID-19 test; to be manufactured in San Diego. Press Releases. AconLabs. November 9, 2023. Accessed 13 November 2023. https://www.aconlabs.com/acon-receives-fda-510k-clearance-for-flowflex-covid-19-test-will-be-manufactured-in-san diego/

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