510(k) K132750
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 19, 2013
- Date Received
- September 3, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection
- Device Class
- Class II
- Regulation Number
- 866.5900
- Review Panel
- PA
- Submission Type
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