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U.S. Department of Health and Human Services

Product Classification

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Device rt-pcr multigene expression test, sentinel lymph node, cancer metastasis detection
Definition A gene expression test for detection of cancer metastasisis an in vitro diagnostic test performed on tissue of interest from patients previously diagnosed with cancer. Results from the test can be used to guide the intra-operative or post-operative decision to remove additional tissue. Post-operative histological evaluation of permanent sections of the tissue specimen, in accordance with usual diagnostic practice and using an appropriate histological sampling scheme, is required.
Physical State Test consists of reagents, instrumentation, software and instructions needed to perform the test method.
Technical Method In vitro replication, amplification and detection of mRNA representing the product of one or multiple genes from a cancerous tissue of interest.
Target Area Human tissue from known cancer patients, removed during biopsy procedures for detection of cancer metastases.
Review Panel Immunology
Product CodeOCB
Premarket Review Division of Immunology and Hematology Devices (DIHD)
Division of Immunology and Hematology Devices (DIHD)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible