Definition: A Mass Spectrometer System Using Matrix-assisted Laser Desorption/ Ionization - Time Of Flight (MALDI-TOF) For The Identification Of Microorganisms Cultured From Human Specimens.
| Device Type ID | 3561 |
| Device Name | System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates |
| Physical State | In Vitro Diagnostic Device |
| Technical Method | Matrix-assisted Laser Desorption/ionization - Time Of Flight (MALDI-TOF) Mass Spectrometry |
| Target Area | Identification Of Microorganisms Cultured From Human Specimens |
| Regulation Description | Mass Spectrometer System For Clinical Use For The Identification Of Microorganisms. |
| 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 | 866.3361 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PEX |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3561 |
| Device | System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates |
| Product Code | PEX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Mass Spectrometer System For Clinical Use For The Identification Of Microorganisms. |
| CFR Regulation Number | 866.3361 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIOMERIEUX | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIOMERIEUX, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BRUKER DALTONICS, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BRUKER DALTONIK GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Incorrect Or Inadequate Test Results | 125 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 96 |
Grounding Malfunction | 5 |
Protective Measures Problem | 5 |
False Device Output | 1 |
Thermal Decomposition Of Device | 1 |
Output Problem | 1 |
Charred | 1 |
Overheating Of Device | 1 |
Missing Test Results | 1 |
Smoking | 1 |
| Total Device Problems | 238 |