# K203220: cobas BKV

- Pathway: 510(k) (Traditional)
- Applicant: Roche Molecular Systems, Inc.
- Decided: Jan 29, 2021 after 88 days
- Product code: QLX (Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna)
- Device class: 2
- Regulation: 21 CFR 866.3183
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN200015 (2020). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202215: cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit, Roche Molecular Systems, Inc. (2020) Summary page 4.

## Most influential descendants
- K241921: Alinity m BKV (2025), 0 descendants of its own

## Indications for use
cobas® BKV is an in vitro nucleic acid amplification test for the quantitation of BK virus (BKV) DNA in human EDTA plasma and urine stabilized in cobas® PCR Media on the cobas® 6800/8800 Systems. In EDTA plasma, cobas® BKV is intended for use as an aid in the management of BKV in transplant patients. In patients undergoing monitoring of BKV in EDTA plasma, serial DNA measurements can be used to indicate the need for potential treatment changes and to assess viral response to treatment. In urine stabilized in cobas® PCR Media, cobas® BKV is intended for use as an aid in the management of BKV in transplant patients. The results from cobas® BKV are intended to be read and analyzed by a qualified licensed healthcare professional in conjunction with clinical signs and symptoms and relevant laboratory findings. Test results must not be the sole basis for patient management decisions. cobas® BKV is not intended for use as a screening test for blood or blood products or human cells, tissues, and cellular and tissue-based products (HCT/Ps).

Source page: https://510kreport.com/device/K203220
Methodology: https://510kreport.com/methodology