Cleared Special

QIAstat-Dx Respiratory Panel Mini (K242353) - FDA 510(k) Clearance

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

K242353 · QIAGEN GmbH · Microbiology device
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Optimized for regulatory review, auditing and printing
Oct 2024
Decision
78d
Days
Class 2
Risk

K242353 is an FDA 510(k) clearance for the QIAstat-Dx Respiratory Panel Mini. Classified as Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents (product code QOF), Class II - Special Controls.

Submitted by QIAGEN GmbH (Hilden, DE). The FDA issued a Cleared decision on October 25, 2024 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3981 - the FDA microbiology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all QIAGEN GmbH devices

Submission Details

510(k) Number K242353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2024
Decision Date October 25, 2024
Days to Decision 78 days
Submission Type Special
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
24d faster than avg
Panel avg: 102d · This submission: 78d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code QOF Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3981
Definition A Device To Detect And Identify Nucleic Acid Targets In Respiratory Specimens From Microbial Agents That Cause The Sars-cov-2 Respiratory Infection And Other Microbial Agents When In A Multi-target Test Is An In Vitro Diagnostic Device Intended For The Detection And Identification Of Sars-cov-2 And Other Microbial Agents When In A Multi-target Test In Human Clinical Respiratory Specimens From Patients Suspected Of Respiratory Infection Who Are At Risk For Exposure Or Who May Have Been Exposed To These Agents. The Device Is Intended To Aid In The Diagnosis Of Respiratory Infection In Conjunction With Other Clinical, Epidemiologic, And Laboratory Data Or Other Risk 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 Microbiology devices follow this clearance model.

Regulatory Consultant

Qiagen
Melissa Mahall

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 - QOF Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents

All 30
Devices cleared under the same product code (QOF) and FDA review panel - the closest regulatory comparables to K242353.
Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel
K241806 · Life Technologies Corporation · Jan 2025
DASH® SARS-CoV-2 & Flu A/B Test
K241652 · Nuclein, LLC · Dec 2024
Panther Fusion SARS-CoV-2/Flu A/B/RSV assay
K242465 · Hologic, Inc. · Nov 2024
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
K241240 · Hologic, Inc. · Jul 2024
BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini
K241194 · Biofire Diagnostics, LLC · May 2024
QIAstat-Dx® Respiratory Panel Plus
K233100 · QIAGEN GmbH · May 2024