K163347 is an FDA 510(k) clearance for the xTAG Cystic Fibrosis 39 Kit v2. This device is classified as a System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection (Class II - Special Controls, product code NUA).
Submitted by Luminex Molecular Diagnostics, Inc. (Toronto, CA). The FDA issued a Cleared decision on December 15, 2016, 17 days after receiving the submission on November 28, 2016.
This device falls under the Medical Genetics FDA review panel. Regulated under 21 CFR 866.5900. 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..
| 510(k) Number | K163347 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | November 28, 2016 |
| Decision Date | December 15, 2016 |
| Days to Decision | 17 days |
| Submission Type | Special |
| Review Panel | Medical Genetics (MG) |
| Summary | Statement |
| Product Code | NUA — System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5900 |
| 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. |