Micro Total Analysis Instrument System
Device Code: 2867
Product Code(s):
OUE Definition: A Micro Total Analysis Instrument System Is A Clinical Multiplex Instrument Intended To Measure And Sort Signals Generated By Fluorescently-labeled Immune Complexes From A Clinical Sample On A Microcapillary Chip. Signals May Be Quantified Using Lase
Device Classification Information
| Device Type ID | 2867 |
| Device Name | Micro Total Analysis Instrument System |
| Physical State | Should Not Include Microarray Systems Or Standard Immunoelectrophoresis Systems. |
| Technical Method | A Micro Total Analysis Instrument System Is An Automated Instrument For Clinical Multiplex Test Systems Which Uses Electrokinetic Mixing And Isotachophoresis On A Microfluidic Chip To Create Immune Complexes Between Target Analyte(s) From A Clinical |
| Target Area | N/A |
| Regulation Description | Instrumentation For Clinical Multiplex Test Systems. |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Immunology |
| 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 | OUE |
| 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 | 2867 |
| Device | Micro Total Analysis Instrument System |
| Product Code | OUE |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Instrumentation For Clinical Multiplex Test Systems. |
| CFR Regulation Number | 862.2570 [🔎] |
| Recalls |
|---|
| Manufacturer | Recall Class | Date Posted |
| 1 | Leica Microsystems, Inc. | II | Jun-07-2014 |
TPLC Last Update: 2019-04-02 20:20:18