Roche receives FDA clearance for COVID-19 PCR test for use on cobas 6800/8800 Systems
Roche announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the cobas SARS-CoV-2 Qualitative PCR test for use on the fully automated cobas 6800 and cobas 8800 Systems. This standalone test is intended for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19 disease, in nasal and nasopharyngeal samples from symptomatic patients who are suspected of having COVID-19 as determined by their healthcare provider.
The cobas SARS-CoV-2 Qualitative test has been available in the U.S. under Emergency Use Authorization (EUA) since March 2020 and was the first commercial molecular test to receive this status. The FDA clearance is based on a comprehensive package submitted to the agency, including analytical and clinical studies.
