Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System
The Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System (product code PLO) is a Class 2 microbiology device that qualitatively detects and identifies microbial-associated nucleic acids in cerebrospinal fluid, regulated under 866.3970. It is indicated for individuals with signs and symptoms of meningitis or encephalitis and aids in diagnosis when used in conjunction with clinical and other laboratory findings. The device requires 510(k) clearance and is not an implant or life-sustaining device.
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Basic Information
- Product Code
- PLO
- Device Class
- FDA class 2
- Regulation Number
- 866.3970
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K242256 | QIAstat-Dx Meningitis/Encephalitis (ME) Panel | Oct 29, 2024 | Substantially Equivalent | QIAGEN GmbH |
| K190219 | Simplexa VZV Direct, Simplexa VZV Positive Control Pack | May 13, 2019 | Substantially Equivalent | Diasorin Molecular, LLC |
| K160462 | FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch | Mar 17, 2016 | Substantially Equivalent | Biofire Diagnostics, LLC |
| DEN150013 | FilmArray Meningitis/Encephalitis(ME) Panel | Oct 08, 2015 | Unknown | Biofire Diagnostics, LLC |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.