A Device to Detect and Identify Microbial Pathogen Nucleic Acids in Cerebrospinal Fluid is a diagnostic tool designed to amplify and identify microbial DNA or RNA directly from cerebrospinal fluid (CSF) specimens. This device is crucial for the rapid and accurate identification of pathogens causing conditions like meningitis or encephalitis, enabling timely clinical intervention.

Intended Use of Device to Detect and Identify Microbial Pathogen Nucleic Acids in Cerebrospinal Fluid

A Device to Detect and Identify Microbial Pathogen Nucleic Acids In Cerebrospinal Fluid is a qualitative in vitro device intended for the detection and identification of microbial-associated nucleic acid sequences from patients suspected of meningitis or encephalitis. A device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid is intended to aid in the diagnosis of meningitis or encephalitis when used in conjunction with clinical signs and symptoms and other clinical and laboratory findings.

Intended Use

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.

Device Description

Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection Systems are in vitro diagnostic devices consisting of reagents and associated instrumentation for the qualitative detection and identification of microbial-associated nucleic acids in cerebrospinal fluid specimens.

The system uses Multiplex Nucleic Acid Amplification Test (NAAT) that utilizes automated sample processing, amplification, and detection to identify a panel of bacterial, viral, and/or fungal pathogen targets directly from CSF specimens.

Key Components

• Disposable Test Cartridge/Panel
• Analyzer Instrument
• Software
• Internal Controls.
• External Controls

It is used with cerebrospinal fluid (CSF) specimens. The results are interpreted by the analyzer and displayed on the screen, with detected analytes shown in red, non-detected analytes in green, and invalid ones in gray.

The system uses single-test cartridges with pre-packaged reagents to perform sample preparation, nucleic acid amplification, and detection. All steps occur within the cartridge, minimizing user exposure to chemicals. The system performs real-time multiplex PCR, detecting fluorescence to identify target analytes.

Performance Testing (Analytical Non-Clinical) for Device to Detect and Identify Microbial Pathogen Nucleic Acids in Cerebrospinal Fluid

• Precision (Repeatability and Reproducibility)
• Limit of Detection
• Analytical Reactivity (Inclusivity)
• Analytical Specificity (Exclusivity)
• Interfering Substances
• Microbial Interference
• Competitive Inhibition
• Carryover
• Sample Stability
• Matrix Equivalency
• Software verification and validation

Clinical Testing

 No Guidance available for 510k submission