Definition: Anaplastic Lymphoma Kinase (ALK) Fluorescence In Situ Hybridization (FISH) Kit Is To Detect Rearrangements Involving The ALK Gene In Formalin-fixed, Paraffin-embedded (FFPE) Non-small Cell Lung Cancer (NSCLC) Tissue Specimens. It Is Indicated To Aid
| Device Type ID | 5043 |
| Device Name | Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement |
| Physical State | Probe And Accessory Assay Kits Contains Pre-treatment Solution, ALK Dual Color Break Apart Probe Mix, Buffers, Counter Stain, And Fluorescence Mounting Medium |
| Technical Method | Fluorescence In Situ Hybridization. |
| Target Area | Formalin-fixed, Paraffin-embedded Human Non-small Cell Lung Cancer Tissue Specimen |
| Review Panel | Pathology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | OWE |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5043 |
| Device | Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement |
| Product Code | OWE |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Device Damaged Prior To Use | 2 |
False Negative Result | 1 |
| Total Device Problems | 3 |