510(k) · Cleared
Clearedcobas BKV
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
Cleared on Jan 29, 2021 as substantially equivalent to K202215 (Roche Molecular Systems, Inc., 2020) after an 88-day review. Its family tree reaches back 2 generations to 2020. 1 later device descends from it.
- Decided
- Jan 29, 2021
- Review
- 88 days
- Class
- Class II
- Product code
- QLX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN200015 (2020). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backDEN200015 cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control…Roche Molecular Systems, Inc. · 2020
- 1 generation backK202215 cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control…Roche Molecular Systems, Inc. · 2020
- This deviceK203220 cobas BKVRoche Molecular Systems, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK241921 Alinity m BKVAbbott Molecular, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K241921Alinity m BKVAbbott Molecular, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K203220 | cobas BKV | Roche Molecular Systems, Inc. | 2021 | — |
| +1 | K241921 | Alinity m BKV | Abbott Molecular, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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
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 |
|---|---|---|---|
| * | K202215 | cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control KitSummary page 4…Quantitative viral nucleic acid test for transplant patient management Product Codes QLX: 21 CFR 866.3183 Predicate Devices cobas® BKV (K202215) Establishment Registration Roche Molecular Systems, Inc. (2243471) 1. DEVICE DESCRIPTION cobas® BKV (Figure 1) i… | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241921 | Alinity m BKV | 2025 | 0 |
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?
- The line of descent spans 1 year and passes through 1 company; a new generation was cleared every 5 months on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K241921 (Abbott Molecular, Inc., 2025) has gone furthest, with 0 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. 2021, 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® 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…
Read the full statement (175 words)
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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203220 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203220: cobas BKV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203220
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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