PMA · Approved
ApprovedRealTime CMV Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Molecular · PAB Cytomegalovirus (Cmv) Dna Quantitative Assay
Approved on Jan 13, 2023 through premarket approval, which rests on the device’s own clinical evidence after a 24-day review.
- Decided
- Jan 13, 2023
- Review
- 24 days
- Class
- Class II
- Product code
- PAB
- Recalls
- None
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
Sources: FDA PMA database (decision fields and supplements), 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 K252481 cobas CMVscore 10.3 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
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.
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. 2023, 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 | — |
https://510kreport.com/device/P160044/S005 · printed Nov 4, 2026
Cite this page
510(k) Report. “P160044/S005: RealTime CMV Assay.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/P160044/S005
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026