# K172287: ipsogen JAK2 RGQ PCR Kit

- Pathway: 510(k) (Traditional)
- Applicant: Qiagen, Inc.
- Decided: Jan 12, 2018 after 168 days
- Product code: PSU (Jak2 Gene Mutation Detection Test)
- Device class: 2
- Regulation: 21 CFR 866.6070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN160028 (2017). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN160028: ipsogen JAK2 RGQ PCR Kit, Qiagen, Inc. (2017) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K172287
Methodology: https://510kreport.com/methodology