NUA — System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection Class II
Classification Details
- Product Code
- NUA
- Device Class
- Class II
- Regulation Number
- 866.5900
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Immunology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K163347 | luminex molecular diagnostics | xTAG Cystic Fibrosis 39 Kit v2 | December 15, 2016 |
| K163336 | luminex molecular diagnostics | xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR | December 15, 2016 |
| K083845 | luminex molecular diagnostics | XTAG CF60 KIT V2 | December 11, 2009 |
| K083846 | luminex molecular diagnostics | XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I0 | September 1, 2009 |
| K083294 | nanosphere | VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST | July 24, 2009 |
| K090901 | osmetech molecular diagnostics | ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING T | July 6, 2009 |
| K063787 | third wave technologies | INPLEX CF MOLECULAR TEST | March 13, 2008 |
| K062028 | celera diagnostics | CYSTIC FIBROSIS GENOTYPING ASSAY, MODEL 6L20-01 | September 7, 2007 |
| K060627 | tm bioscience corporation | TAG-IT CYSTIC FIBROSIS KIT | June 7, 2006 |
| K060543 | clinical micro sensors | ESENSOR CYSTIC FIBROSIS CARRIER DETECTION SYSTEM, MODEL ESENSOR 4800 | March 28, 2006 |
| K051435 | clinical micro sensors | ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYST | January 19, 2006 |
| DEN050004 | tm bioscience corporation | TAG-IT CYSTIC FIBROSIS KIT | May 9, 2005 |