PFR — System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection Class II

FDA Device Classification

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-NumberApplicantDevice NameDate
K124006illuminaILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAYNovember 19, 2013