December 2022—Roche announced plans for the U.S. launch of the Cobas 5800 system, a compact, fully-automated molecular instrument that aims to offer a flexible PCR testing solution to help clinicians diagnose infectious diseases.
The Cobas 5800 system, a class II–exempt medical device, allows labs to test multiple assays simultaneously, delivers up to 144 results in an eight-hour shift, and has a walkaway time of up to eight hours. The workflow encompasses sample transfer and preparation, amplification and detection, result calculation, and delivery to the laboratory information system.
Roche received FDA premarket approval for the Cobas HIV-1 assay, the first in the Cobas x800 family of assays available for use on the Cobas 5800 system. The system and assay will be commercially available in the fourth quarter of this year.
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