510(k) · Cleared
Clearedipsogen 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
Cleared on Jan 12, 2018 as substantially equivalent to DEN160028 (Qiagen, Inc., 2017) after a 168-day review. Its family tree reaches back 1 generation to 2017.
- Decided
- Jan 12, 2018
- Review
- 168 days
- Class
- Class II
- Product code
- PSU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN160028 (2017). No later device cites it as a predicate yet.
- Root · 1 generation backDEN160028 ipsogen JAK2 RGQ PCR KitQiagen, Inc. · 2017
- This deviceK172287 ipsogen JAK2 RGQ PCR KitQiagen, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN160028 | ipsogen JAK2 RGQ PCR Kit | Qiagen, Inc. | 2017 | — |
| 0 (this device) | K172287 | ipsogen JAK2 RGQ PCR Kit | Qiagen, Inc. | 2018 | — |
Sources: FDA 510(k) 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
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN160028 | ipsogen JAK2 RGQ PCR KitSummary page 4…uct Code: PSU Predicate Device Manufacturer Product Name 510(k) No. QIAGEN GmbH ipsogen® JAK2 RGQ PCR Kit DEN160028 July 28, 2017 QIAGEN ipsogen® JAK2 RGQ PCR Kit CONFIDENTIAL 510(k) Premarket Not… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
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. 2018, 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 Myeloproliferative Neoplasm in conjunction with other clinicopathological factors.
This test does not detect less common JAK2 mutations associated with Myeloproliferative Neoplasm including mutations in exon 12 and is not intended for stand-alone diagnosis of Myeloproliferative Neoplasm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172287 · printed Nov 5, 2026
Cite this page
510(k) Report. “K172287: ipsogen JAK2 RGQ PCR Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K172287
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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