FDA product code · Microbiology
Cytomegalovirus (Cmv) Dna Quantitative Assay
9 FDA decisions since 2012. 510(k) reviews decided 2021–2025 took a median of 88 days (half between 58 and 162). No recall names this code. The most-cited predicate is P210022, named by 1 later device.
Cytomegalovirus (CMV) DNA Quantitative Assay is an in vitro nucleic acid assay for the quantitative measurement of CMV DNA in human plasma. The assay can be used to measure CMV DNA levels serially at baseline and during the course of antiviral treatment to assess virological response to treatment. The test results must be interpreted within the context of all relevant clinical and laboratory findings.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of PAB at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
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 | — |
Planning a device in PAB? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report