PMA · Approved
Recalled · Class II · 2022therascreen FGFR RGQ RT-PCR Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
QIAGEN GmbH · OWD Somatic Gene Mutation Detection System
Approved on Apr 12, 2019 through premarket approval, which rests on the device’s own clinical evidence after a 155-day review. It has been recalled 4 times.
- Decided
- Apr 12, 2019
- Review
- 155 days
- Class
- Class III
- Product code
- OWD
- Recalls
- 4
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P180043 has 9 supplements since 2020: 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 |
|---|---|
| 2020 | 2 |
| 2021 | 1 |
| 2023 | 2 |
| 2024 | 2 |
| 2025 | 1 |
| 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 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 |
|---|---|---|---|---|
| Jul 20, 2022 | Class II | Z-1652-2022 | Under Investigation by firm | Increased occurrence rate of false positive results, lead to a false positive sample result that could subsequently be incorrectly reported from the laboratory. A false positive result could lead to the risk of the patient being exposed… |
| Jul 20, 2022 | Class II | Z-1651-2022 | Under Investigation by firm | Increased occurrence rate of false positive results, lead to a false positive sample result that could subsequently be incorrectly reported from the laboratory. A false positive result could lead to the risk of the patient being exposed… |
| Jul 20, 2022 | Class II | Z-1650-2022 | Under Investigation by firm | Increased occurrence rate of false positive results, lead to a false positive sample result that could subsequently be incorrectly reported from the laboratory. A false positive result could lead to the risk of the patient being exposed… |
| May 6, 2019 | Class II | Z-1891-2019 | Under Investigation by firm | The deparaffinization solution contains a contaminant, which leads to reduced lysis efficiency of the affected lot, resulting in significantly reduced yields and less sensitive downstream applications. |
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. 2019, 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/P180043 · printed Nov 6, 2026
Cite this page
510(k) Report. “P180043: therascreen FGFR RGQ RT-PCR Kit.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P180043
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026