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 I
| Device Type ID | 3568 |
| Device Name | Meningitis/encephalitis Pathogen Multiplex Nucleic Acid Detection System |
| 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 Description | Device To Detect And Identify Microbial Pathogen Nucleic Acids In Cerebrospinal Fluid. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.3970 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PLO |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3568 |
| Device | Meningitis/encephalitis Pathogen Multiplex Nucleic Acid Detection System |
| Product Code | PLO |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Device To Detect And Identify Microbial Pathogen Nucleic Acids In Cerebrospinal Fluid. |
| CFR Regulation Number | 866.3970 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIOMERIEUX SA | ||
GRANTED | 1 | |
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Incorrect, Inadequate Or Imprecise Result Or Readings | 5 |
False Positive Result | 3 |
False Negative Result | 2 |
Incorrect Or Inadequate Test Results | 1 |
| Total Device Problems | 11 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | BioFire Diagnostics, LLC | II | Nov-10-2018 |