Roche BKV test FDA cleared on Cobas 6800/8800 systems

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Sept. 9, 2020—Roche received FDA 510(k) clearance for the Cobas BKV test on the Cobas 6800 and 8800 systems.

The Cobas BKV test is a real-time polymerase chain reaction test with dual-target technology that provides quantitative accuracy and guards against the risk of sequence variations that may be present in the BK virus. The test has robust coverage with a limit of detection of 21.5 IU/mL and an expanded linear range from 21.5 IU/mL to 1E+08 IU/mL in EDTA plasma.