Device |
fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement |
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 in the selection of patients for treatment with specific FDA approved therapeutic drugs. |
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 |
Product Code | OWE |
Premarket Review |
Division of Molecular Genetics and Pathology
(DMGP)
Division of Molecular Genetics and Pathology
(DMGP)
|
Submission Type |
PMA
|
Device Class |
3
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |