K083845 is an FDA 510(k) clearance for the XTAG CF60 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, Ontario, CA). The FDA issued a Cleared decision on December 11, 2009, 352 days after receiving the submission on December 24, 2008.
This device falls under the Pathology 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 | K083845 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 24, 2008 |
| Decision Date | December 11, 2009 |
| Days to Decision | 352 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | Summary PDF |
| 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. |