# DEN160028: ipsogen JAK2 RGQ PCR Kit

- Pathway: De Novo (Direct)
- Applicant: Qiagen, Inc.
- Decided: Mar 27, 2017 after 269 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K172287: ipsogen JAK2 RGQ PCR Kit (2018), 0 descendants of its own

## 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 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.

Source page: https://510kreport.com/device/DEN160028
Methodology: https://510kreport.com/methodology