Roche’s Cobas Qualitative PCR COVID-19 Test Gets 510(k) Clearance

Roche has received 510(k) clearance from the FDA for its cobas SARS-CoV-2 qualitative polymerase chain reaction (PCR) test, previously authorized for emergency use, to be used in the company’s automated cobas 6800 and cobas 8800 systems.

The molecular test uses nasal and nasopharyngeal samples from symptomatic patients who are suspected by their healthcare provider of COVID-19 infection.

The change in status from emergency authorization to 510(k) clearance was supported by additional data from analytical and clinical studies, the company said.

“Based on continuous analysis performed since the onset of the pandemic,” the tests detect all variants of the SARS-CoV-2 virus, Roche said.