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U.S. Department of Health and Human Services

Product Classification
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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 CodeOWE
Premarket Review Office of In Vitro Diagnostics (OHT7)
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
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