510(k) DEN150013
DEN150013 is an FDA 510(k) premarket notification submitted by Biofire Diagnostics, LLC for the device "FilmArray Meningitis/Encephalitis(ME) Panel". The FDA issued a decision of De Novo Granted on October 8, 2015. The device falls under product code PLO (Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System), a Class II device regulated under 21 CFR 866.3970. Biofire Diagnostics, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- October 8, 2015
- Date Received
- April 9, 2015
- Clearance Type
- Direct
- 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.