PMA · Approved
Recalled · Class II · 2016Cobas HBV Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Molecular Systems, Inc. · MKT Hepatitis Viral B Dna Detection
Approved on Oct 14, 2015 through premarket approval, which rests on the device’s own clinical evidence after a 173-day review. It has been recalled once.
- Decided
- Oct 14, 2015
- Review
- 173 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.
P150014 has 57 supplements since 2016: 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 |
|---|---|
| 2016 | 6 |
| 2017 | 6 |
| 2018 | 10 |
| 2019 | 12 |
| 2020 | 6 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 6 |
| 2024 | 6 |
| 2025 | 3 |
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 |
|---|---|---|---|---|
| Jul 15, 2016 | Class II | Z-0110-2017 | Device Design | Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process. |
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. 2015, 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/P150014 · printed Nov 6, 2026
Cite this page
510(k) Report. “P150014: Cobas HBV Test.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P150014
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026