Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System
FDA product code PLO · Class II (moderate risk) · 21 CFR 866.3970 · 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 conjunction with clinical and other laboratory findings.
3510(k) clearances
0PMA approvals
2recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242256 | QIAstat-Dx Meningitis/Encephalitis (ME) PanelPLO · Traditional | QIAGEN GmbH | 10/29/2024SE |
| K190219 | Simplexa VZV Direct, Simplexa VZV Positive Control PackPLO · Traditional | Diasorin Molecular, LLC | 05/13/2019SE |
| K160462 | FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray TorchPLO · Special | Biofire Diagnostics, LLC | 03/17/2016SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2548-2020 Class II | MOL3650 Simplexa VZV Direct - Product Usage: is intended for use on the LIAISON MDX…Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of… | DiaSorin Molecular LLC | 05/12/2020Terminated |
| Z-0446-2019 Class II | -Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray Meningitis/Encephalitis (ME) Panel REF…Firm identified an issue in the manufacturing process which might contribute to elevated rates of false… | BioFire Diagnostics, LLC | 09/10/2018Terminated |