Cleared Traditional

K242256 - QIAstat-Dx Meningitis/Encephalitis (ME) Panel (FDA 510(k) Clearance)

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

K242256 · QIAGEN GmbH · Microbiology device
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Oct 2024
Decision
90d
Days
Class 2
Risk

K242256 is an FDA 510(k) clearance for the QIAstat-Dx Meningitis/Encephalitis (ME) Panel. Classified as Meningitis/encephalitis Pathogen Multiplex Nucleic Acid Detection System (product code PLO), Class II - Special Controls.

Submitted by QIAGEN GmbH (Hilden, DE). The FDA issued a Cleared decision on October 29, 2024 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3970 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all QIAGEN GmbH devices

Submission Details

510(k) Number K242256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2024
Decision Date October 29, 2024
Days to Decision 90 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
12d faster than avg
Panel avg: 102d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PLO Meningitis/encephalitis Pathogen Multiplex Nucleic Acid Detection System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3970
Definition A Meningitis/encephalitis Pathogen Multiplex Nucleic Acid Detection System Is A Qualitative In Vitro Diagnostic Test For The Direct Detection And Identification Of Microbial-associated Nucleic Acids In Cerebrospinal Fluid. The Test Is Indicated For Individuals With Signs And Symptoms Of Meningitis Or Encephalitis And Aids In Diagnosis Of Agents Of Meningitis Or Encephalitis When Used In Conjunction With Clinical 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 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.