Definition: A Droplet Digital PCR System Is An In Vitro Diagnostic Amplification And Detection Test System That Is Intended For The Amplification, Detection (qualitative And Quantitative), And Analysis Of Nucleic Acid Samples, Isolated From Clinical Specimens, W
| Device Type ID | 658 |
| Device Name | Droplet Digital Pcr System |
| Physical State | The System May Consist Of Separate Components Used For Specific Purposes (e.g., Droplet Generator And Droplet Reader), Associated Software, And Consumables. Should Not Include Real-time Thermocyclers Or Massively Parallel Or High-throughput Sequencer |
| Technical Method | The Nucleic Acid Molecules Partitioned Into The Individual Droplets Are Amplified Using Real-time PCR Methods, Labeled With Fluorescently Labeled Probes Or Other Fluorescent Labeling Means, And The Result Of Each Droplet Reaction Is Counted And Quant |
| Target Area | Nucleic Acids Isolated From Human Clinical Specimens |
| 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)
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| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 862.2570 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PHG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |