NUA · System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
Immunology · 21 CFR 866.5900 · Class 2
Overview
| Product Code | NUA |
|---|---|
| Device Name | System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection |
| Regulation | 21 CFR 866.5900 |
| Device Class | Class 2 |
| Review Panel | Immunology |
Identification
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.
Classification Rationale
Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: CFTR Gene Mutation Detection System.” See § 866.1(e) for the availability of this guidance document.
Special Controls
*Classification.* Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: CFTR Gene Mutation Detection System.” See § 866.1(e) for the availability of this guidance document.
Recent Cleared Devices (12 of 12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K163347 | xTAG Cystic Fibrosis 39 Kit v2 | Luminex Molecular Diagnostics, Inc. | Dec 15, 2016 | SESK |
| K163336 | xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR | Luminex Molecular Diagnostics, Inc. | Dec 15, 2016 | SESK |
| K083845 | XTAG CF60 KIT V2 | Luminex Molecular Diagnostics, Inc. | Dec 11, 2009 | SESE |
| K083846 | XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267 | Luminex Molecular Diagnostics, Inc. | Sep 1, 2009 | SESE |
| K083294 | VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST | Nanosphere, Inc. | Jul 24, 2009 | SESE |
| K090901 | ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING TEST, ESENSOR INSTRUMENT, MODELS XT-8 | Osmetech Molecular Diagnostics | Jul 6, 2009 | SESE |
| K063787 | INPLEX CF MOLECULAR TEST | Third Wave Technologies, Inc. | Mar 13, 2008 | SESE |
| K062028 | CYSTIC FIBROSIS GENOTYPING ASSAY, MODEL 6L20-01 | Celera Diagnostics | Sep 7, 2007 | SESE |
| K060627 | TAG-IT CYSTIC FIBROSIS KIT | Tm Bioscience Corporation | Jun 7, 2006 | SESE |
| K060543 | ESENSOR CYSTIC FIBROSIS CARRIER DETECTION SYSTEM, MODEL ESENSOR 4800 | Clinical Micro Sensors, Inc. | Mar 28, 2006 | SESE |
| K051435 | ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYSTEM, MODEL 4800 | Clinical Micro Sensors | Jan 19, 2006 | SESE |
| DEN050004 | TAG-IT CYSTIC FIBROSIS KIT | Tm Bioscience Corporation | May 9, 2005 | DENG |
Top Applicants
- Luminex Molecular Diagnostics, Inc. — 4 clearances
- Tm Bioscience Corporation — 2 clearances
- Celera Diagnostics — 1 clearance
- Clinical Micro Sensors — 1 clearance
- Clinical Micro Sensors, Inc. — 1 clearance
