ACON Receives FDA Marketing Clearance for The Flowflex® COVID-19 Test

ACON Receives FDA Marketing Clearance for The Flowflex® COVID-19 Test

The U.S. Food & Drug Administration (FDA) granted 510(k) marketing clearance for the ACON Flowflex® COVID-19 Antigen Home Test in November 2023. This is the very first FDA 510(k) for an over-the-counter (OTC) rapid antigen test for SARS-CoV-2, the virus which causes COVID-19. The 510(k) version of the Flowflex COVID-19 Antigen Home Test is expected to be  produced domestically in ACON Laboratories’ new manufacturing facility in San Diego, CA.

The 510(k) cleared Flowflex COVID-19 Antigen Home Test is indicated for use only by symptomatic individuals within the first six days after symptom onset of the virus. An initial negative result must be followed by retesting between 48 and 72 hours after the first test. ACON intends to start distribution of the 510(k) cleared test in 2024 and plans additional communications to the market in advance of distribution.

In October 2021, ACON received Emergency Use Authorization (EUA) for the The Flowflex COVID-19 Antigen Home Test, a simple nasal swab test, which is easily performed at home without a prescription. The test gained popularity during the Omicron variant surge as ACON manufactured and delivered hundreds of millions of tests to the market. Since then, the intended use of the EUA version of the Flowflex COVID-19 Antigen Home Test has evolved based on the collective knowledge of SARS-CoV-2 infections in a population which has been increasingly vaccinated and/or exposed to the virus. The EUA version is indicated for use by both symptomatic and asymptomatic individuals. If symptomatic, the test can be performed during the first seven days after symptom onset, when tested at least twice over three days with at least 48 hours between tests. Asymptomatic individuals can use it when testing three times over five days with at least 48 hours between tests.

The EUA for the Flowflex COVID-19 Antigen Home Test has not been revoked. ACON Laboratories will continue to supply EUA test kits to meet the public’s demand for safe and easy home testing through the upcoming cough and cold season. ACON will continue to ship, and ACON distributors can continue to distribute/sell the EUA version of Flowflex COVID-19 Antigen Home Test kits, which still include asymptomatic testing in the intended use.

Differences Between The 510(k) and EUA Versions
The only differences between the current EUA version of the Flowflex COVID-19 Antigen Home Test and the 510(k) version are the intended use and a simplified package insert inside the kit box. The product name, UPC, dimensions, kit contents, 24-month shelf-life, and steps to perform a test, remain the same.

FDA 510(k) clearance under K230828 only includes symptomatic testing based on the clinical data which was provided and reviewed. ACON has agreed to submit additional asymptomatic data to support the future addition of an asymptomatic testing claim. Until then, the EUA version may continue to be used for symptomatic and asymptomatic testing, but the 510(k) version may only be used for symptomatic testing.

When Will The 510(k) Cleared Test Production Begin?
EUA Flowflex will remain available through the upcoming cough/cold season through 2024. A firm transition date has not yet been established. A limited quantity of 510(k) Flowflex tests will be manufactured in China as ACON ramps up production at its new San Diego facility. The majority of 510(k) Flowflex delivered to the US market will be manufactured in San Diego, however China  product manufacturing will still be available to provide surge capacity tests if necessary.

Nationwide Medical Supply Inc., the leading online medical supplier and an Authorized Distributor of Flowflex® COVID 19 Antigen Home Tests, anticipates having the 510(k) cleared tests, when they become available in 2024.

“As one of the largest distributors of over-the-counter COVID Tests, we’re pleased to offer the new 510 (k) cleared tests when they are available,” commented Kevin Finley, CEO Nationwide Medical Supply Inc.

Nationwide Medical Supply Inc. is the leading PPE Provider for at-home COVID Tests, N95 Masks, and PPE Supplies and more. Founded in 2020, Nationwide Medical Supply, Inc. is committed to supplying individuals, businesses, medical facilities, and government operations with quality medical and PPE supplies at affordable prices.

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