PFS — System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection Class II
FDA product code PFS covers "System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection", a Class II medical device regulated under 21 CFR 866.5900. Submissions are reviewed by the Immunology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- PFS
- Device Class
- Class II
- Regulation Number
- 866.5900
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Immunology
- Implant
- No
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
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K132750 | illumina | ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY | November 19, 2013 |