PMA · Approved
Recalled · 2010Abbott Realtime HBV Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Molecular, Inc. · MKT Hepatitis Viral B Dna Detection
Approved on Aug 13, 2010 through premarket approval, which rests on the device’s own clinical evidence after a 666-day review. It has been recalled once.
- Decided
- Aug 13, 2010
- Review
- 666 days
- Class
- Class II
- Product code
- MKT
- Recalls
- 1
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P080026 has 24 supplements since 2011: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2011 | 1 |
| 2012 | 2 |
| 2013 | 7 |
| 2014 | 2 |
| 2015 | 2 |
| 2016 | 4 |
| 2017 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2025 | 2 |
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 MKT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 20, 2010 | Not classified | Z-1399-2011 | Other | Internal testing identified the potential of under filled and over filled enzyme reagent vials which may result in obtaining less than the total number of tests per kit as described on the package insert. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All MKT devicesMKT Hepatitis Viral B Dna Detection: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MKT
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MKT
Too few MKT 510(k)s in any year since 2007 to give a median.
Recalls per year · MKT
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MKT
2in 2025
MAUDE reports naming product code MKT, 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 | — | 1 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 2 | — | 2 | 5 |
| 2011 | 6 | — | 0 | 11 |
| 2012 | 9 | — | 0 | 8 |
| 2013 | 17 | — | 0 | 3 |
| 2014 | 7 | — | 0 | 2 |
| 2015 | 8 | — | 0 | 0 |
| 2016 | 16 | — | 1 | 0 |
| 2017 | 13 | — | 0 | 1 |
| 2018 | 29 | — | 0 | 1 |
| 2019 | 28 | — | 0 | 1 |
| 2020 | 14 | — | 0 | 0 |
| 2021 | 9 | — | 0 | 0 |
| 2022 | 9 | — | 2 | 2 |
| 2023 | 16 | — | 0 | 2 |
| 2024 | 18 | — | 0 | 2 |
| 2025 | 10 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/P080026 · printed Nov 6, 2026
Cite this page
510(k) Report. “P080026: Abbott Realtime HBV Assay.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P080026
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026