510(k) · Cleared
Clearedcobas BKV, 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. · QMI Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna
Cleared on Sep 2, 2020 as substantially equivalent to DEN200015 (Roche Molecular Systems, Inc., 2020) after a 27-day review. Its family tree reaches back 1 generation to 2020. 2 later devices descend from it.
- Decided
- Sep 2, 2020
- Review
- 27 days
- Class
- Class II
- Product code
- QMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN200015 (2020). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backDEN200015 cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control…Roche Molecular Systems, Inc. · 2020
- This deviceK202215 cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control…Roche Molecular Systems, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK203220 cobas BKVRoche Molecular Systems, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK241921 Alinity m BKVAbbott Molecular, Inc. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN200015 | cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit | Roche Molecular Systems, Inc. | 2020 | — |
| 0 (this device) | K202215 | cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit | Roche Molecular Systems, Inc. | 2020 | — |
| +1 | K203220 | cobas BKV | Roche Molecular Systems, Inc. | 2021 | — |
| +2 | K241921 | Alinity m BKV | Abbott Molecular, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) 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 QMI? 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 QMI device
- #1 K241921 Alinity m BKVscore 9.7 · 3 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN200015 | cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control KitSummary page 4…Quantitative viral nucleic acid test for transplant patient management Product Codes QMI: 21 CFR 866.3183 Predicate Devices cobas® EBV (DEN200015) Establishment Registration Roche Molecular Systems, Inc. (2243471) 1. DEVICE DESCRIPTION cobas® BKV is based on ful… | 2020 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203220 | cobas BKV | 2021 | 1 |
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?
How does its category compare?
All QMI devicesQMI Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · QMI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QMI
Too few QMI 510(k)s in any year since 2007 to give a median.
Recalls per year · QMI
No recall names QMI since 2007.
Adverse event reports per year · QMI
No MAUDE report names QMI since 2007.
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 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
cobas® BKV is an in vitro nucleic acid amplification test for the quantitation of BK virus (BKV) DNA in human EDTA plasma on the cobas® 6800/8800 Systems. cobas® BKV is intended for use as an aid in the management of BKV in transplant patients. In patients undergoing monitoring of BKV, serial DNA measurements can be used to indicate the need for potential treatment changes and to assess viral response to treatment. The results from cobas® BKV are…
Read the full statement (138 words)
cobas® BKV is an in vitro nucleic acid amplification test for the quantitation of BK virus (BKV) DNA in human EDTA plasma on the cobas® 6800/8800 Systems.
cobas® BKV is intended for use as an aid in the management of BKV in transplant patients. In patients undergoing monitoring of BKV, serial DNA measurements can be used to indicate the need for potential treatment changes and to assess viral response to treatment.
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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202215 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202215: cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202215
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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