PFR — System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection Class II
Classification Details
- Product Code
- PFR
- Device Class
- Class II
- Regulation Number
- 866.5900
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Immunology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K124006 | illumina | ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY | November 19, 2013 |