| Device |
meningitis/encephalitis pathogen multiplex nucleic acid detection system |
| Regulation Description |
Device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid. |
| Definition |
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. |
| Physical State |
Meningitis/encephalitis pathogen multiplex nucleic acid detection systems are in vitro devices that consist of reagents and associated instrumentation for detection and identification of microbial nucleic acids in cerebrospinal fluid specimens. |
| Technical Method |
A qualitative in vitro diagnostic assay that detects and identifies microbial-associated nucleic acids in cerebrospinal fluid specimens. |
| Target Area |
In vitro diagnostic device |
| Regulation Medical Specialty |
Microbiology |
| Review Panel |
Microbiology |
|---|
| Product Code | PLO |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Microbiology Devices
(DMD)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
866.3970
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
