510(k) K160462
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 17, 2016
- Date Received
- February 19, 2016
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System
- Device Class
- Class II
- Regulation Number
- 866.3970
- Review Panel
- MI
- Submission Type
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.