Cleared Traditional

K254032 - QIAstat-Dx Gastrointestinal Panel 2 (FDA 510(k) Clearance)

Also includes:
QIAstat-Dx GI Panel 2 Mini B&V QIAstat-Dx GI Panel 2 Mini B

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

K254032 · QIAGEN GmbH · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2026
Decision
83d
Days
Class 2
Risk

K254032 is an FDA 510(k) clearance for the QIAstat-Dx Gastrointestinal Panel 2. Classified as Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System (product code PCH), Class II - Special Controls.

Submitted by QIAGEN GmbH (Hilden, DE). The FDA issued a Cleared decision on March 9, 2026 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3990 - the FDA microbiology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all QIAGEN GmbH devices

Submission Details

510(k) Number K254032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2025
Decision Date March 09, 2026
Days to Decision 83 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 102d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3990
Definition A Gastrointestinal Pathogen Panel Multiplex Nucleic Acid Assay Is A Qualitative In Vitro Diagnostic Device Intended To Simultaneously Detect And Identify Multiple Gastrointestinal Microbial Nucleic Acids Extracted From Human Stool Specimens. The Detection And Identification Of A Specific Gastrointestinal Microbial Nucleic Acid From Individuals Exhibiting Signs And/or Symptoms Of Gastrointestinal Infection Aids In The Diagnosis Of Gastrointestinal Infection When Used In Conjunction With Clinical Evaluation And Other Laboratory Findings.
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 Microbiology devices follow this clearance model.

Regulatory Consultant

STAT-Dx Life, S.L. (A QIAGEN Company)
Sonia Pablo

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System

All 36
Devices cleared under the same product code (PCH) and FDA review panel - the closest regulatory comparables to K254032.
Xpert GI Panel
K251721 · Cepheid · Jan 2026
QIAstat-Dx Gastrointestinal Panel 2
K252329 · QIAGEN GmbH · Oct 2025
Panther Fusion GI Bacterial Assay
K251868 · Hologic · Sep 2025
Panther Fusion GI Expanded Bacterial Assay
K251993 · Hologic, Inc. · Sep 2025
QIAstat-Dx GI Panel 2 Mini B
K250324 · QIAGEN GmbH · Feb 2025
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid
K243885 · Biofire Diagnostics, LLC · Jan 2025