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FDA Clears First Over-the-Counter Antigen Test for COVID-19
FDA clears 1st OTC antigen test for COVID-19 by ACON Labs. Safe, accurate, and indicated for children. Expanding access to at-home testing. #COVID19 #FDA
The U.S. Food and Drug Administration (FDA) has taken a significant step in expanding access to COVID-19 testing by clearing the marketing of the first over-the-counter (OTC) antigen test. ACON Laboratories’ Flowflex COVID-19 Antigen Home Test, previously authorized for emergency use, has now undergone a traditional FDA premarket review pathway and is the second home COVID-19 test to receive such clearance. Notably, it is also the first test indicated for use in children under 18. This development aligns with the FDA’s commitment to advancing at-home testing options for various medical conditions, thus enhancing patient access to testing.
Advancing Access to At-Home Testing:
Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, highlighted the significance of this achievement, stating, “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.” The FDA’s proactive collaboration with test developers seeking to market their products beyond emergency use authorization underscores their commitment to expanding patient access to testing and supporting the development of at-home tests for various medical conditions.
Flowflex COVID-19 Antigen Home Test:
The Flowflex COVID-19 Antigen Home Test is an OTC test designed for symptomatic individuals within six days of symptom onset. It is cleared for use by individuals aged 14 years or older testing themselves or adults testing individuals aged two years or older. In an FDA-reviewed study, this test demonstrated impressive accuracy, correctly identifying 89.8% of positive and 99.3% of negative samples in individuals displaying signs and symptoms of upper respiratory infection.
Testing Guidelines:
Similar to antigen tests authorized for emergency use, the Flowflex COVID-19 Antigen Home Test should be used at least twice over a three-day period, with a minimum of 48 hours between tests. This means that if a symptomatic individual initially receives a negative test result, they should be re-tested once between 48 and 72 hours after the first test using an antigen test for COVID-19 or follow up with a molecular COVID-19 test.
510(k) Premarket Review Pathway:
The FDA reviewed the ACON Flowflex COVID-19 Antigen Home Test through the 510(k) premarket review pathway. The 510(k) is a submission made to the FDA to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This detailed review process ensures the safety and effectiveness of the test and provides confidence to consumers who choose to utilize it.
The FDA’s clearance of the Flowflex COVID-19 Antigen Home Test as the first over-the-counter antigen test for COVID-19 represents a significant milestone in expanding access to testing. This advancement allows individuals, including children, to conveniently and accurately test for COVID-19 from the comfort of their homes. With the ongoing commitment of organizations like the FDA and test developers, we can continue to develop and enhance at-home testing options, ultimately helping to control the spread of COVID-19 and improve public health.
About the FDA:
The FDA, as an agency within the U.S. Department of Health and Human Services, plays a vital role in assuring the safety, effectiveness, and security of various healthcare products and regulating industries that impact public health. From drugs and vaccines to medical devices and food safety, the FDA is dedicated to protecting and promoting the well-being of the American public.
Source: FDA
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