DeviceClearance

Product code PFS— Immunology

ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY

Classification name
System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence 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 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”

— U.S. Food and Drug Administration, device classification record for product code PFS under 21 CFR 866.5900, via openFDA

Market context for product code PFS

FDA has cleared 1 device under product code PFS, 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 PFS

Recent clearances under product code PFS

Data sourced from openFDA. This site is unofficial and independent of the FDA.