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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.
Physical State Multiplex qualitative amplification based detection system. Should not include devices which use sequencing based detection methods.
Technical Method Uses multiplex polymerase chain reaction to amplify specific DNA variants located on the CFTR gene using non-sequencing based methods.
Target Area Human peripheral whole blood or clinical samples.
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeNUA
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
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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