De Novo · Granted
Grantedipsogen JAK2 RGQ PCR Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Qiagen, Inc. · PSU Jak2 Gene Mutation Detection Test
Granted on Mar 27, 2017 as a new device type through De Novo after a 269-day review. 1 later device descends from it.
- Decided
- Mar 27, 2017
- Review
- 269 days
- Class
- Class II
- Product code
- PSU
- Recalls
- None
1 later device descends from it, 1 citing it directly.
- This deviceDEN160028 ipsogen JAK2 RGQ PCR KitQiagen, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK172287 ipsogen JAK2 RGQ PCR KitQiagen, Inc. · 2018
Most influential descendants
Showing 1 of 1 · See all- K172287ipsogen JAK2 RGQ PCR KitQiagen, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN160028 | ipsogen JAK2 RGQ PCR Kit | Qiagen, Inc. | 2017 | — |
| +1 | K172287 | ipsogen JAK2 RGQ PCR Kit | Qiagen, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PSU? 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?
De Novo decisions do not claim a predicate device.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172287 | ipsogen JAK2 RGQ PCR Kit | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K172287 (Qiagen, Inc., 2018) has gone furthest, with 0 descendants of its own.
How does its category compare?
All PSU devicesPSU Jak2 Gene Mutation Detection Test: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · PSU
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · PSU
Too few PSU 510(k)s in any year since 2007 to give a median.
Recalls per year · PSU
No recall names PSU since 2007.
Adverse event reports per year · PSU
1in 2018
MAUDE reports naming product code PSU, 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 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ipsogen JAK2 RGQ PCR Kit is a qualitative in vitro diagnostic test for the detection of the JAK2 V617F/G1849T allele in genomic DNA extracted from EDTA whole blood. The ipsogen JAK2 RGQ PCR Kit is a real time PCR test performed on the QIAGEN Rotor-Gene Q MDx instrument. The test is intended for use as an adjunct to evaluation of suspected Polycythemia Vera, in conjunction with other clinicopathological factors.
This test does not detect less common mutations associated with Polycythemia Vera including mutations in exon 12 and is not intended for stand-alone diagnosis of Polycythemia Vera.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN160028 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN160028: ipsogen JAK2 RGQ PCR Kit.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN160028
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026