FDA Product Code PLO: Meningitis/encephalitis Pathogen Multiplex Nucleic Acid Detection System
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.
Leading manufacturers include QIAGEN GmbH.
FDA 510(k) Cleared Meningitis/encephalitis Pathogen Multiplex Nucleic Acid Detection System Devices (Product Code PLO)
About Product Code PLO - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code PLO since 2015, with 3 receiving FDA clearance (average review time: 99 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for PLO submissions have been consistent, averaging 90 days recently vs 102 days historically.
PLO devices are reviewed by the Microbiology panel. Browse all Microbiology devices →