NUA

12 FDA 510(k) clearances · Product code

FDA profile

Official device name

System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection

Device class

Class II (moderate risk)

Regulation

21 CFR 866.5900

Medical specialty

Immunology

FDA definition

The cftr gene mutation detection system is a device used to simultaneously detect and identify a panel of mutations and variants in the cftr gene. It is intended as an aid in confirmatory diagnostic testing of individuals with suspected cystic fibrosis (cf), carrier identification, and newborn screening. This device is not intended for stand-alone diagnostic purposes, prenatal diagnostic, pre-implantation or population screening.

Adverse events (MAUDE)

2006: 4
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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