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# Roche BKV Test Cleared by FDA
- URL: https://www.fdaweb.com/roche-bkv-test-cleared-by-fda/
- Published: 2020-09-09T12:00:00.000Z
- Updated: 2026-09-14T16:28:05.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147615

FDA has cleared a Roche 510(k) for the cobas BKV Test and its use on the cobas 6800 and 8800 Systems. The test is intended to provide standardized, high-quality results that can help healthcare professionals better assess the risk of complications caused by the BK virus in transplant patients and identify effective treatment options, the company says. The BK virus is part of the polyomavirus family that can cause severe transplant-associated complications. Infection often occurs early in life and then it remains inactive until it reactivates in immunocompromised patients such as transplant recipients, Roche says.

The BKV Test is a polymerase chain reaction viral load test has been calibrated to a World Health Organization international standard, according to the company. It was previously granted an FDA breakthrough device designation.