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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, mutations & variants panel sequencing detection
Definition The CFTR gene mutation detection system is used to simultaneously detect and identify a specified panel of mutations and variants in the CFTR gene using sequencing methods. It is intended for carrier screening, as an aid in confirmatory diagnostic testing of individuals with suspected cystic fibrosis (CF), and as an initial test to aid in the diagnosis of individuals with suspected CF. It is not intended for stand-alone diagnostic purposes, prenatal diagnostic, or pre-implantation screening.
Physical State Multiplex qualitative amplification based test system. The device may include a use for newborn screening. Should not include devices using non-sequencing based detection methods.
Technical Method The assay uses multiplex polymerase chain reaction to amplify and identify a specific panel of DNA variants located on the CFTR gene with DNA sequencing based detection methods. 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 CodePFR
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