510(k) K163347
K163347 is an FDA 510(k) premarket notification submitted by Luminex Molecular Diagnostics, Inc. for the device "xTAG Cystic Fibrosis 39 Kit v2". The FDA issued a decision of Substantially Equivalent (kit) on December 15, 2016. The device falls under product code NUA (System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection), a Class II device regulated under 21 CFR 866.5900. Luminex Molecular Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- December 15, 2016
- Date Received
- November 28, 2016
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
- Device Class
- Class II
- Regulation Number
- 866.5900
- Review Panel
- PA
- Submission Type
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.