System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
The Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Gene Mutation Detection System is a molecular diagnostic device that simultaneously detects and identifies a panel of mutations and variants in the CFTR gene, used as an aid in confirmatory diagnostic testing of individuals with suspected cystic fibrosis, carrier identification, and newborn screening. It is not intended for stand-alone diagnostics, prenatal, pre-implantation, or population screening. It is an FDA Class 2 device regulated under 21 CFR 866.5900 in the Immunology specialty, reviewed by the Pathology panel, with product code NUA, requiring 510(k) clearance. It is not an implant and does not carry life-sustaining support designation.
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Basic Information
- Product Code
- NUA
- Device Class
- FDA class 2
- Regulation Number
- 866.5900
- Medical Specialty
- Immunology
- Review Panel
- PA
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K163347 | xTAG Cystic Fibrosis 39 Kit v2 | Dec 15, 2016 | Unknown | Luminex Molecular Diagnostics, Inc. |
| K163336 | xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR | Dec 15, 2016 | Unknown | Luminex Molecular Diagnostics, Inc. |
| K083845 | XTAG CF60 KIT V2 | Dec 11, 2009 | Substantially Equivalent | Luminex Molecular Diagnostics, Inc. |
| K083846 | XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267 | Sep 01, 2009 | Substantially Equivalent | Luminex Molecular Diagnostics, Inc. |
| K083294 | VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST | Jul 24, 2009 | Substantially Equivalent | Nanosphere, Inc. |
| K090901 | ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING TEST, ESENSOR INSTRUMENT, MODELS XT-8 | Jul 06, 2009 | Substantially Equivalent | Osmetech Molecular Diagnostics |
| K063787 | INPLEX CF MOLECULAR TEST | Mar 13, 2008 | Substantially Equivalent | Third Wave Technologies, Inc. |
| K062028 | CYSTIC FIBROSIS GENOTYPING ASSAY, MODEL 6L20-01 | Sep 07, 2007 | Substantially Equivalent | Celera Diagnostics |
| K060627 | TAG-IT CYSTIC FIBROSIS KIT | Jun 07, 2006 | Substantially Equivalent | Tm Bioscience Corporation |
| K060543 | ESENSOR CYSTIC FIBROSIS CARRIER DETECTION SYSTEM, MODEL ESENSOR 4800 | Mar 28, 2006 | Substantially Equivalent | Clinical Micro Sensors, Inc. |
| K051435 | ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYSTEM, MODEL 4800 | Jan 19, 2006 | Substantially Equivalent | Clinical Micro Sensors |
| DEN050004 | TAG-IT CYSTIC FIBROSIS KIT | May 09, 2005 | Unknown | Tm Bioscience Corporation |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.