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U.S. Department of Health and Human Services

Product Classification
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Device system, cystic fibrosis transmembrane conductance regulator, gene mutation detection
Regulation Description Cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection system.
Definition The cftr gene mutation detection system is a device used to simultaneously detect and identify a panel of mutations and variants in the cftr gene.It is intended as an aid in confirmatory diagnostic testing of individuals with suspected cystic fibrosis (cf), carrier identification, and newborn screening.This device is not intended for stand-alone diagnostic purposes, prenatal diagnostic, pre-implantation or population screening.
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeNUA
Submission Type 510(k)
Regulation Number 866.5900
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • CFTR Gene Mutation Detection Systems - Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document
Third Party Review Not Third Party Eligible
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