Definition: A DNA-based Test For Minimal Residual Disease Is An In Vitro Diagnostic Device That Identifies And Quantifies Specific Nucleic Acid Sequences Isolated From Human Specimens To Estimate The Percentage Of Cells That Harbor The Specific Sequence(s). The
| Device Type ID | 5032 |
| Device Name | Dna-based Test For Minimal Residual Disease For Hematologic Malignancies |
| Physical State | Test Consists Of Reagents, Instrumentation, Software And Instructions Needed To Perform The Test Method. Should Not Include Devices Intended To Measure Or Quantify Circulating Or Cell-free Nucleic Acid Sequences Isolated From Human Plasma Specimens. |
| Technical Method | This Test Uses Polymerase Chain Reaction And/or Sequencing-based Methods To Quantify Specific Nucleic Acid Sequences For The Purpose Of Measuring Minimal Residual Disease. The Test May Utilize Other Technologies And/or Quantification Methods |
| Target Area | Human Bone Marrow Aspirate And Peripheral Blood. Excludes Circulating DNA In Plasma. |
| Regulation Medical Specialty | Pathology |
| Review Panel | Pathology |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.6100 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QDC |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |