Definition: This Test Is Intended To Measure The Degree Of Similarity Between The RNA Expression Pattern In A Patient?s Fresh-frozen Tumor And The RNA Expression Patterns In A Database Of Tumor Samples For Some Common Malignant Tumor Types That Were Diagnosed Ac
| Device Type ID | 6249 |
| Device Name | Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types |
| Physical State | Gene Expression Systems, Which Include Either Microarray Systems Or Reverse-transcriptase Polymerase Chain Reaction (RT-PCR) Systems. Steps For Microarray Systems Include RNA Isolation Kits, CDNA Synthesis Kits, In Vitro Transcription Kits, Hybridiza |
| Technical Method | Uses Gene Expression And Computer Algorithm That Estimate Degree Of Similarity Between Analyzed Specimen And Examples Of Various Tumor Types Comprising A Database. Gene Expression Involves Isolation Of RNA From Frozen Tumor Tissue Sections, Amplifica |
| Target Area | Fresh Frozen Tumor Tissue Sections |
| Regulation Description | Amphetamine Test System. |
| Regulation Medical Specialty | Toxicology |
| Review Panel | Toxicology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 862.3100 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OIW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 6249 |
| Device | Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types |
| Product Code | OIW |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Amphetamine Test System. |
| CFR Regulation Number | 862.3100 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CANCER GENETICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |