Product code NUA

Device name: System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
Medical specialty: Immunology
Device class: 2
Regulation number: 866.5900
Review panel: PA
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
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.
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K163336	xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR	Luminex Molecular Diagnostics, Inc.	2016-12-15
K163347	xTAG Cystic Fibrosis 39 Kit v2	Luminex Molecular Diagnostics, Inc.	2016-12-15
K083845	XTAG CF60 KIT V2	Luminex Molecular Diagnostics, Inc.	2009-12-11
K083846	XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267	Luminex Molecular Diagnostics, Inc.	2009-09-01
K083294	VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST	Nanosphere, Inc.	2009-07-24
K090901	ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING TEST, ESENSOR INSTRUMENT, MODELS XT-8	Osmetech Molecular Diagnostics	2009-07-06
K063787	INPLEX CF MOLECULAR TEST	Third Wave Technologies, Inc.	2008-03-13
K062028	CYSTIC FIBROSIS GENOTYPING ASSAY, MODEL 6L20-01	Celera Diagnostics	2007-09-07
K060627	TAG-IT CYSTIC FIBROSIS KIT	Tm Bioscience Corporation	2006-06-07
K060543	ESENSOR CYSTIC FIBROSIS CARRIER DETECTION SYSTEM, MODEL ESENSOR 4800	Clinical Micro Sensors, Inc.	2006-03-28
K051435	ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYSTEM, MODEL 4800	Clinical Micro Sensors	2006-01-19
DEN050004	TAG-IT CYSTIC FIBROSIS KIT	Tm Bioscience Corporation	2005-05-09

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00840487100455	xTAG® Cystic Fibrosis Mutation Detection Kit	Luminex Molecular Diagnostics, Inc	2016-09-09
00840487100479	xTAG® Cystic Fibrosis (CFTR) 60 kit v2	Luminex Molecular Diagnostics, Inc	2016-09-09
00840487100141	xTAG® Cystic Fibrosis (CFTR) 39 kit v2	Luminex Molecular Diagnostics, Inc	2016-09-09

Related 510(k) Records#