FDA Grants 510(k) Marketing Clearance to Flowflex COVID-19 Antigen Home Test

The FDA has granted 510(k) marketing clearance to ACON Laboratories Inc’s Flowflex COVID-19 Antigen Home Test. The regulatory action makes Flowflex the first over-the-counter (OTC) rapid antigen test for SARS-CoV-2 to gain FDA 510(k) marketing clearance.¹

Image credit: JeromeCronenberger | stock.adobe.com

“We are pleased to receive the first FDA 510(k) for an OTC COVID antigen test, which is symbolic of ACON’s leadership position in the market. This is also the first FDA 510(k) for an OTC rapid antigen test for any infectious disease,” said Michael Lynch, ACON Laboratories Vice President of Sales and Marketing, in a press release.¹ “We believe this represents FDA’s commitment to empowering people to take greater charge of their healthcare.”

The simple nasal swab test can be performed at home without a prescription. The FDA granted Emergency Use Authorization (EUA) to the Flowflex test in October 2021.

ACON announced that the 510(k) version of the Flowflex test will be manufactured in its new 97,000 square foot manufacturing facility located in San Diego, California. The test is approved for use only by those who are symptomatic within the first six days after the onset of COVID-19 symptoms. ACON noted that an initial negative test result should be followed by retesting between 48 and 72 hours following the first test.

The company said it plans to begin distributing the 510(k) cleared test in 2024 with additional communications to the market prior to distribution.

“The entire ACON team is excited to play a leading role in bringing affordable and reliable home diagnostics for infectious diseases to the public, and hopefully this will be just the first of several such tests to be manufactured at our new state-of-the-art manufacturing facility in San Diego,” Lynch said.¹

To date, the COVID-19 pandemic has caused more than 1.1 million deaths and 6.4 million hospitalizations, according to the CDC (Table).²

Figure. COVID-19 Update for the United States. Credit: CDC.

The Flowflex COVID-19 Antigen Home Test quickly rose to prominence during the period in which the COVID-19 Omicron variant spread widely, with ACON producing hundreds of millions of tests that reached the market, the manufacturer said.

Since that time, ACON said the intended use of the EUA version of the Flowflex COVID-19 Antigen Home Test evolved based on growing data regarding SARS-CoV-2 infections across populations that had already been vaccinated and/or exposed to COVID-19. Under the EUA, the indication for the Flowflex test is for use by symptomatic and asymptomatic individuals.

For those who are symptomatic, Flowflex can be used during the first seven days following the onset of symptoms, with testing performed at least twice over three days and at least 48 hours between tests. Those who are asymptomatic can use Flowflex to test for COVID-19 three times over five days and at least 48 hours between tests.

Notably, the EUA for Flowflex COVID-19 Antigen Home Test is still in place. ACON Laboratories said it will continue supplying EUA test kits to facilitate home testing through the upcoming cough and cold season.

ACON cautions that improper use of COVID-19 antigen tests may produce false negative test results, which can lead to delayed diagnosis or inappropriate treatment for SARS-CoV-2.

References

1. ACON Receives FDA 510(k) Clearance for Flowflex® COVID-19 Test; Will be Manufactured in San Diego. ACON Laboratories Inc. News release. Published November 9, 2023. Accessed November 10, 2023. https://www.aconlabs.com/acon-receives-fda-510k-clearance-for-flowflex-covid-19-test-will-be-manufactured-in-san-diego/

2. CDC COVID Data Tracker. CDC. Webpage. Updated November 6, 2023. Accessed November 10, 2023.