PMA · Approved
Recalled · Class II · 2020Oncomine Dx Target Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Life Technologies Corporation · PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
Approved on Jun 22, 2017 through premarket approval, which rests on the device’s own clinical evidence after a 248-day review. It has been recalled 6 times.
- Decided
- Jun 22, 2017
- Review
- 248 days
- Class
- Class III
- Product code
- PQP
- Recalls
- 6
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P160045 has 44 supplements since 2017: 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 |
|---|---|
| 2017 | 3 |
| 2018 | 6 |
| 2019 | 5 |
| 2020 | 6 |
| 2021 | 4 |
| 2022 | 5 |
| 2023 | 7 |
| 2024 | 4 |
| 2025 | 3 |
| 2026 | 1 |
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 PQP? 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 |
|---|---|---|---|---|
| Mar 16, 2020 | Class II | Z-1705-2020 | Incorrect or no expiration date | Extended Expiration Date prior to clearance |
| Mar 16, 2020 | Class II | Z-1706-2020 | Incorrect or no expiration date | Extended Expiration Date prior to clearance |
| Mar 16, 2020 | Class II | Z-1707-2020 | Incorrect or no expiration date | Extended Expiration Date prior to clearance |
| Mar 16, 2020 | Class II | Z-1704-2020 | Incorrect or no expiration date | Extended Expiration Date prior to clearance |
| Feb 8, 2018 | Class II | Z-1480-2018 | Process control | The lower concentration of the RNA panel could cause a NO CALL or FALSE NEGATIVE for the reporting of ROS1 fusion. If a physician relies on a false negative result, crizotinib could be improperly excluded from the patient's treatment… |
| Dec 4, 2017 | Class II | Z-1279-2018 | Device Design | The Oncomine Dx Target Test may report erroneous results when used off-label for samples other than non-small cell lung cancer (NSCLC) tumor specimens. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All PQP devicesPQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · PQP
37so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · PQP
Too few PQP 510(k)s in any year since 2007 to give a median.
Recalls per year · PQP
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PQP
2in 2023
MAUDE reports naming product code PQP, 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 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 6 | — | 0 | 1 |
| 2018 | 15 | — | 1 | 1 |
| 2019 | 21 | — | 1 | 0 |
| 2020 | 25 | — | 0 | 1 |
| 2021 | 17 | — | 0 | 1 |
| 2022 | 33 | — | 2 | 1 |
| 2023 | 34 | — | 0 | 2 |
| 2024 | 34 | — | 0 | 0 |
| 2025 | 21 | — | 0 | 0 |
| 2026 | 37 | — | 3 | — |
https://510kreport.com/device/P160045 · printed Nov 6, 2026
Cite this page
510(k) Report. “P160045: Oncomine Dx Target Test.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P160045
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026