Cleared Traditional

QIAstat-Dx Meningitis/Encephalitis (ME) Panel

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

About This 510(k) Submission

K242256 is an FDA 510(k) clearance for the QIAstat-Dx Meningitis/Encephalitis (ME) Panel, a Meningitis/encephalitis Pathogen Multiplex Nucleic Acid Detection System (Class II — Special Controls, product code PLO), submitted by QIAGEN GmbH (Hiden, DE). The FDA issued a Cleared decision on October 29, 2024, 90 days after receiving the submission on July 31, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3970.

Submission Details

510(k) Number K242256 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code PLO — Meningitis/encephalitis Pathogen Multiplex Nucleic Acid Detection System
Device Class Class II — 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.