FDA grants 510(k) approval for COVID-19 test from BioFire Defense

Nov. 8, 2021

The U.S. Food and Drug Administration (FDA) said it has granted De Novo 510(k) approval for a COVID-19 test from BioFire Defense.

Unlike an emergency use authorization (EUA), the 510(k) designation allows the company to market the test after the COVID-19 public health emergency is over.

The BioFire COVID-19 Test 2 is a molecular diagnostic test that detects SARS-CoV-2 in nasopharyngeal swab samples, where the sample is taken from deep inside the nose, reaching the back of the throat. The test is for people with symptoms who are suspected of having COVID-19 by their healthcare provider, the FDA said.

In March 2021, The FDA had granted the first marketing authorization for a COVID-19 test using the De Novo pathway for the BioFire Respiratory Panel 2.1 (RP2.1). The BioFire RP2.1, which was developed by BioFire Diagnostics, is for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infections, including COVID-19.

BioFire Defense and BioFire Diagnostics are sister companies and subsidiaries of bioMerieux.

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