Mass Spectrometer For Clinical Multiplex Test Systems
Device Code: 647
Product Code(s):
OTA Definition: A Mass Spectrometer For Clinical Multiplex Test Systems Is A Device That Is Intended To Measure And Sort Multiple Signals Generated By An Assay From A Clinical Sample. The Generated Signals Are Produced By Ionizing The Compound Or Biological Material
Device Classification Information
| Device Type ID | 647 |
| Device Name | Mass Spectrometer For Clinical Multiplex Test Systems |
| Physical State | Mass Spectrometer |
| Technical Method | Multiplex Mass Spectrometer. The Device May Integrate Sample Preprocessing/work Station, Liquid Or Gas Chromatography, Raw Data Storage Mechanisms And Other Essential Hardware And Software Components Along With The Basic Modules Of A Mass Spectrometr |
| Target Area | IVD |
| Regulation Description | Instrumentation For Clinical Multiplex Test Systems. |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 862.2570 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OTA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 647 |
| Device | Mass Spectrometer For Clinical Multiplex Test Systems |
| Product Code | OTA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Instrumentation For Clinical Multiplex Test Systems. |
| CFR Regulation Number | 862.2570 [🔎] |
TPLC Last Update: 2019-04-02 19:38:04