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- Subpart B—Biological StainsCFR Sub-Part
- Subpart C—Cell And Tissue Culture ProductsCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart E—Immunology Laboratory Equipment and ReagentsCFR Sub-Part
- Subpart E—Specimen Preparation ReagentsCFR Sub-Part
- Subpart F—Automated and Semi-Automated Hematology DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- DEPLambda, Peroxidase, Antigen, Antiserum, Control2Product Code
- DEYIgm, Peroxidase, Antigen, Antiserum, Control2Product Code
- DFDKappa, Peroxidase, Antigen, Antiserum, Control2Product Code
- DGHIgd, Peroxidase, Antigen, Antiserum, Control2Product Code
- DAAIgg, Peroxidase, Antigen, Antiserum, Control2Product Code
- DGOIge, Peroxidase, Antigen, Antiserum, Control2Product Code
- DHFD/Km-1, Antigen, Antiserum, Control1Product Code
- LYECytokeratins2Product Code
- NUASystem, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection2Product Code
- PFRSystem, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection2Product Code
- PFSSystem, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection2Product Code
- PKBAutosomal Recessive Carrier Screening Gene Mutation Detection System2Product Code
- Subpart G—Tumor Associated Antigen immunological Test SystemsCFR Sub-Part
- Subpart H—Hematology Kits and PackagesCFR Sub-Part
- Subpart J—Products Used In Establishments That Manufacture Blood and Blood ProductsCFR Sub-Part
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System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection
- Page Type
- Product Code
- Definition
- The CFTR gene mutation detection system is used to simultaneously detect and identify a specified panel of mutations and variants in the CFTR gene using sequencing methods. It is intended for carrier screening, as an aid in confirmatory diagnostic testing of individuals with suspected cystic fibrosis (CF), and as an initial test to aid in the diagnosis of individuals with suspected CF. It is not intended for stand-alone diagnostic purposes, prenatal diagnostic, or pre-implantation screening.
- Physical State
- Multiplex qualitative amplification based test system. The device may include a use for newborn screening. Should not include devices using non-sequencing based detection methods.
- Technical Method
- The assay uses multiplex polymerase chain reaction to amplify and identify a specific panel of DNA variants located on the CFTR gene with DNA sequencing based detection methods. Variants are identified by comparison to a specified reference sequence.
- Target Area
- Human peripheral whole blood or clinical samples
- Regulation Medical Specialty
- Immunology
- Review Panel
- Pathology
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 866.5900
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 866.5900 Cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection system
§ 866.5900 Cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection system.
(a) 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.
(b) 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.
[70 FR 61738, Oct. 26, 2005]