Cleared Traditional

K172287 - ipsogen JAK2 RGQ PCR Kit (FDA 510(k) Clearance)

Class II Pathology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K172287 · Qiagen, Inc. · Pathology device
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Jan 2018
Decision
168d
Days
Class 2
Risk

K172287 is an FDA 510(k) clearance 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 Cleared decision on January 12, 2018 after a review of 168 days - an extended review cycle.

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 establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Pathology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K172287 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2017
Decision Date January 12, 2018
Days to Decision 168 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 77d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.