PMA · Approved
Recalled · Class II · 2021cobas EGFR MUTATION TEST v2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Molecular Systems, Inc. · OWD Somatic Gene Mutation Detection System
Approved on Jun 1, 2016 through premarket approval, which rests on the device’s own clinical evidence after a 175-day review. It has been recalled once.
- Decided
- Jun 1, 2016
- Review
- 175 days
- Class
- Class III
- Product code
- OWD
- Recalls
- 1
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P150047 has 2 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 | 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 OWD? 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 |
|---|---|---|---|---|
| Sep 3, 2021 | Class II | Z-0083-2022 | Under Investigation by firm | False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, may lead to inappropriate treatment |
No ancestor or descendant has a Class I recall.
How does its category compare?
All OWD devicesOWD Somatic Gene Mutation Detection System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · OWD
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWD
Too few OWD 510(k)s in any year since 2007 to give a median.
Recalls per year · OWD
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWD
3in 2025
MAUDE reports naming product code OWD, 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 | 3 | — | 0 | 0 |
| 2012 | 4 | — | 1 | 0 |
| 2013 | 10 | — | 0 | 0 |
| 2014 | 6 | — | 1 | 2 |
| 2015 | 31 | — | 0 | 1 |
| 2016 | 21 | — | 0 | 1 |
| 2017 | 17 | — | 0 | 2 |
| 2018 | 36 | — | 0 | 0 |
| 2019 | 16 | — | 0 | 0 |
| 2020 | 15 | — | 1 | 3 |
| 2021 | 13 | — | 1 | 57 |
| 2022 | 12 | — | 2 | 53 |
| 2023 | 24 | — | 0 | 15 |
| 2024 | 9 | — | 0 | 5 |
| 2025 | 8 | — | 0 | 3 |
| 2026 | 9 | — | 0 | — |
https://510kreport.com/device/P150047 · printed Nov 6, 2026
Cite this page
510(k) Report. “P150047: cobas EGFR MUTATION TEST v2.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P150047
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026