Definition: The Anaplastic Lymphoma Kinase (ALK) Antibody Is A Qualitative Immunohistochemical Antibody Intended To Identify ALK Protein Expression In Human Clinical Tissue Specimens. The ALK Antibody Is Indicated As An Aid In Identifying Patients Eligible For T
| Device Type ID | 5049 |
| Device Name | Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase |
| Physical State | The Device Includes A Monoclonal Primary Antibody And Accessory Reagents, Including Secondary Antibodies, Buffers, Substrates, And Counterstains. The Device May Be Intended For Manual Or Automated Staining Methods. |
| Technical Method | The Test Uses A Primary Monoclonal Antibody To Detect The Presence Of Expressed Antigen Protein In Fixed Tissue Specimens. Antibody-antigen Complexes Are Visualized Using An Enzyme Conjugated Primary Or Secondary Antibody To Catalyze A Color-producin |
| Target Area | Human Clinical Tissue Specimens. |
| 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 | PKW |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5049 |
| Device | Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase |
| Product Code | PKW |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Incorrect Or Inadequate Test Results | 2 |
None | 1 |
| Total Device Problems | 3 |