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U.S. Department of Health and Human Services

Product Classification

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Device classifier, prognostic, recurrence risk assessment, rna gene expression, breast cancer
Regulation Description Gene expression profiling test system for breast cancer prognosis.
Definition A device which uses a gene expression profile of a breast cancer tumor, from patients stage i or stage ii lymph node negative, with a tumor size of <5.0 cm, to provide a risk assessment for distant recurrence of breast cancer.The result is indicated for use only as a prognostic marker by physicians along with a number of other factors to assess the risk of recurrence of breast cancer.
Physical State RNA isolation kits, enzymes, fluorescent dyes, hybridization systems, computer
Technical Method Uses Gene expression and computer algorithm that gives risk of recurrence. Gene expression involves isolation of RNA from frozen tumor tissue sections, amplification of RNA and hybridization.
Target Area breast tumor tissue sections
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeNYI
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.6040
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Class II Special Controls Guidance Document: Gene Expression Profiling Test System for Breast Cancer Prognosis
Third Party Review Not Third Party Eligible
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