# DEN200015: cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit

- Pathway: De Novo (Direct)
- Applicant: Roche Molecular Systems, Inc.
- Decided: Jul 30, 2020 after 150 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
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K202215: cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit (2020), 2 descendants of its own
- K212778: Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075) (2022), 1 descendant of its own
- K203220: cobas BKV (2021), 1 descendant of its own
- K243489: Alinity m EBV (09N43-095) (2025), 0 descendants of its own
- K241921: Alinity m BKV (2025), 0 descendants of its own

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

Source page: https://510kreport.com/device/DEN200015
Methodology: https://510kreport.com/methodology