Product code PFR— Immunology
ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY
- Classification name
- System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection
- Device class
- Class 2
- Regulation
- 21 CFR 866.5900
- Advisory panel
- Immunology
- Total cleared
- 1
- First cleared
- Most recent
FDA classification 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.”
Market context for product code PFR
FDA has cleared device under product code PFR, all in 2013, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code PFR
Recent clearances under product code PFR
Data sourced from openFDA. This site is unofficial and independent of the FDA.