De Novo · Granted
Grantedcobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Molecular Systems, Inc. · QLX Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna
Granted on Jul 30, 2020 as a new device type through De Novo after a 150-day review. 5 later devices descend from it.
- Decided
- Jul 30, 2020
- Review
- 150 days
- Class
- Class II
- Product code
- QLX
- Recalls
- None
5 later devices descend from it, 2 citing it directly.
- This deviceDEN200015 cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control…Roche Molecular Systems, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK202215 cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control…Roche Molecular Systems, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK212778 Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit…Abbott Molecular, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK203220 cobas BKVRoche Molecular Systems, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK243489 Alinity m EBV (09N43-095)Abbott Molecular, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK241921 Alinity m BKVAbbott Molecular, Inc. · 2025
Most influential descendants
Showing 5 of 5 · See all- K202215cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control KitRoche Molecular Systems, Inc. · 2020 · cites it directly2descendants
- K212778Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085)…Abbott Molecular, Inc. · 2022 · cites it directly1descendant
- K203220cobas BKVRoche Molecular Systems, Inc. · 2021 · 2 generations on1descendant
- K243489Alinity m EBV (09N43-095)Abbott Molecular, Inc. · 2025 · 2 generations on0descendants
- K241921Alinity m BKVAbbott Molecular, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN200015 | cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit | Roche Molecular Systems, Inc. | 2020 | — |
| +1 | K202215 | cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit | Roche Molecular Systems, Inc. | 2020 | — |
| +1 | K212778 | Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No.… | Abbott Molecular, Inc. | 2022 | — |
| +2 | K203220 | cobas BKV | Roche Molecular Systems, Inc. | 2021 | — |
| +2 | K243489 | Alinity m EBV (09N43-095) | Abbott Molecular, Inc. | 2025 | — |
| +3 | K241921 | Alinity m BKV | Abbott Molecular, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 2 | 0 |
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QLX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QLX device
- #1 K243489 Alinity m EBV (09N43-095)score 10.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K202215 (Roche Molecular Systems, Inc., 2020) has gone furthest, with 2 descendants of its own.
How does its category compare?
All QLX devicesQLX Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · QLX
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QLX
Too few QLX 510(k)s in any year since 2007 to give a median.
Recalls per year · QLX
No recall names QLX since 2007.
Adverse event reports per year · QLX
2in 2025
MAUDE reports naming product code QLX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 1 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (150 words)
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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN200015 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN200015: cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN200015
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026