Not Cleared Direct

DEN160028 - ipsogen JAK2 RGQ PCR Kit (FDA 510(k) Clearance)

Class II Pathology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN160028 · Qiagen, Inc. · Pathology device
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Mar 2017
Decision
269d
Days
Class 2
Risk

DEN160028 is an FDA 510(k) submission (not cleared) for the ipsogen JAK2 RGQ PCR Kit. Classified as Jak2 Gene Mutation Detection Test (product code PSU), Class II - Special Controls.

Submitted by Qiagen, Inc. (Germantown, US). The FDA issued a Not Cleared (DENG) decision on March 27, 2017 after a review of 269 days.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 866.6070 - the FDA pathology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. Elevated predicate reliance profile. With 269 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Qiagen, Inc. devices

Submission Details

510(k) Number DEN160028 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received July 01, 2016
Decision Date March 27, 2017
Days to Decision 269 days
Submission Type Direct
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
192d slower than avg
Panel avg: 77d · This submission: 269d
Pathway characteristics

Device Classification

Product Code PSU Jak2 Gene Mutation Detection Test
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.6070
Definition The Jak2 Gene Mutation Detection System Is A Device Used To Detect Mutations And Variants In The Jak2 Gene. It Is Intended For Use As An Adjunct To Evaluation Of Suspected Polycythemia Vera, In Conjunction With Other Clinicopathological Factors.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Pathology devices follow this clearance model.