PLO — Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System Class II
Classification Details
- Product Code
- PLO
- Device Class
- Class II
- Regulation Number
- 866.3970
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K242256 | qiagen | QIAstat-Dx Meningitis/Encephalitis (ME) Panel | October 29, 2024 |
| K190219 | diasorin molecular | Simplexa VZV Direct, Simplexa VZV Positive Control Pack | May 13, 2019 |
| K160462 | biofire diagnostics | FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch | March 17, 2016 |
| DEN150013 | biofire diagnostics | FilmArray Meningitis/Encephalitis(ME) Panel | October 8, 2015 |