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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, variant gene sequence detection
Regulation Description Cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection system.
Definition The CFTR gene variant detection system is used to sequence specified regions of the CFTR gene to detect gene variants. It is intended as an aid in confirmatory diagnostic testing of individuals with suspected cystic fibrosis (CF), those with atypical or non-classic presentation of CF, or when other mutation panels have failed to identify both causative mutations. It is not intended for screening (carrier, newborn, population, or pre-implantation), prenatal diagnostic, or used for stand-alone diagnostic purposes
Physical State Multiplex qualitative amplification with DNA sequencing detection methods. Should not include devices using non-sequencing based detection methods.
Technical Method Uses multiplex polymerase chain reaction to amplify and sequence specific regions of the CFTR gene with DNA sequencing based detection method. Variants are identified by comparison to a specified reference sequence.
Target Area Human peripheral whole blood or clinical samples
Regulation Medical Specialty Immunology
Review Panel Pathology
Product CodePFS
Premarket Review Division of Molecular Genetics and Pathology (DMGP)
Division of Molecular Genetics and Pathology (DMGP)
Submission Type 510(k)
Regulation Number 866.5900
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible