510(k) K190219
K190219 is an FDA 510(k) premarket notification submitted by Diasorin Molecular, LLC for the device "Simplexa VZV Direct, Simplexa VZV Positive Control Pack". The FDA issued a decision of Substantially Equivalent on May 13, 2019. 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. Diasorin Molecular, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 13, 2019
- Date Received
- February 4, 2019
- Clearance Type
- Traditional
- 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.