Definition: A Device Which Uses A Gene Expression Profile Of A Breast Cancer Tumor, From Patients Stage I Or Stage Ii Lymph Node Negative, With A Tumor Size Of
| Device Type ID | 4921 |
| Device Name | Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer |
| Physical State | RNA Isolation Kits, Enzymes, Fluorescent Dyes, Hybridization Systems, Computer |
| Technical Method | Uses Gene Expression And Computer Algorithm That Gives Risk Of Recurrence. Gene Expression Involves Isolation Of RNA From Frozen Tumor Tissue Sections, Amplification Of RNA And Hybridization. |
| Target Area | Breast Tumor Tissue Sections |
| Regulation Description | Gene Expression Profiling Test System For Breast Cancer Prognosis. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Pathology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.6040 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NYI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4921 |
| Device | Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer |
| Product Code | NYI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Gene Expression Profiling Test System For Breast Cancer Prognosis. |
| CFR Regulation Number | 866.6040 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
AGENDIA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NANOSTRING TECHNOLOGIES INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |