510(k) · Cleared
Clearedcobas CMV
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Molecular Systems, Inc. · PAB Cytomegalovirus (Cmv) Dna Quantitative Assay
Cleared on Nov 3, 2025 as substantially equivalent to P160041 (Roche Molecular Systems, Inc., 2017) after an 88-day review. Its family tree reaches back 1 generation to 2017.
- Decided
- Nov 3, 2025
- Review
- 88 days
- Class
- Class II
- Product code
- PAB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to P160041 (2017). No later device cites it as a predicate yet.
- Root · 1 generation backP160041 Cobas CMVRoche Molecular Systems, Inc. · 2017
- This deviceK252481 cobas CMVRoche Molecular Systems, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P160041 | Cobas CMV | Roche Molecular Systems, Inc. | 2017 | — |
| 0 (this device) | K252481 | cobas CMV | Roche Molecular Systems, Inc. | 2025 | — |
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 PAB? 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 PAB device
- #1 K243485 Alinity m CMVscore 9.6 · 1 generation · 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 |
|---|---|---|---|
| * | P160041 | Cobas CMVSummary page 7…t to significant characteristics of the identified predicate device, cobas® CMV Quantitative nucleic acid test for use on the cobas® 5800/6800/8800 systems (cobas® CMV) (P160041). Page 3 Table… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
How does its category compare?
All PAB devicesPAB Cytomegalovirus (Cmv) Dna Quantitative Assay: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · PAB
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PAB
88in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PAB
No recall names PAB since 2007.
Adverse event reports per year · PAB
4in 2025
MAUDE reports naming product code PAB, 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 | 3 | — | 0 | 0 |
| 2013 | 10 | — | 0 | 0 |
| 2014 | 4 | — | 0 | 1 |
| 2015 | 8 | — | 0 | 2 |
| 2016 | 7 | — | 0 | 1 |
| 2017 | 13 | — | 0 | 1 |
| 2018 | 24 | — | 0 | 2 |
| 2019 | 21 | — | 0 | 1 |
| 2020 | 8 | — | 0 | 0 |
| 2021 | 4 | — | 0 | 0 |
| 2022 | 9 | — | 0 | 1 |
| 2023 | 14 | — | 0 | 3 |
| 2024 | 16 | — | 0 | 2 |
| 2025 | 3 | 88 | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
cobas CMV is an in vitro nucleic acid amplification test for the quantitation of cytomegalovirus (CMV) DNA in human EDTA plasma.
cobas CMV is intended for use as an aid in the management of CMV in solid organ transplant patients and in hematopoietic stem cell transplant patients. In patients receiving anti-CMV therapy, serial DNA measurements can be used to assess viral response to treatment.
The results from cobas CMV must be interpreted within the context of all relevant clinical and laboratory findings.
cobas CMV is not intended for use as a screening test for blood or blood products.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252481 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252481: cobas CMV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252481
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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