QIAstat-Dx Meningitis/Encephalitis (ME) Panel

FDA 510(k) K242256 · QIAGEN GmbH

Substantially Equivalent

510(k) numberK242256

Submission

Device name
QIAstat-Dx Meningitis/Encephalitis (ME) Panel
Applicant
QIAGEN GmbH
Hilden, DE
Received
July 31, 2024
Decision date
October 29, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PLO – Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3970
Specialty
Microbiology

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…

Other 510(k)s with product code PLO

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K190219Simplexa VZV Direct, Simplexa VZV Positive Control PackPLO · Traditional Diasorin Molecular, LLC05/13/2019SE
K160462FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray TorchPLO · Special Biofire Diagnostics, LLC03/17/2016SE

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Questions and answers

When was QIAstat-Dx Meningitis/Encephalitis (ME) Panel cleared by the FDA?

QIAstat-Dx Meningitis/Encephalitis (ME) Panel (K242256) received a 510(k) decision of Substantially Equivalent on October 29, 2024, 90 days after the submission was received.

What is the product code of K242256?

The FDA product code is PLO – Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System, a Class II (moderate risk) device regulated under 21 CFR 866.3970.