Definition: The CFTR Gene Variant Detection System Is Used To Sequence Specified Regions Of The CFTR Gene To Detect Gene Variants. It Is Intended As An Aid In Confirmatory Diagnostic Testing Of Individuals With Suspected Cystic Fibrosis (CF), Those With Atypical
| Device Type ID | 4924 |
| Device Name | System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection |
| Physical State | Multiplex Qualitative Amplification With DNA Sequencing Detection Methods. Should Not Include Devices Using Non-sequencing Based Detection Methods. |
| Technical Method | Uses Multiplex Polymerase Chain Reaction To Amplify And Sequence Specific Regions Of The CFTR Gene With DNA Sequencing Based Detection Method. Variants Are Identified By Comparison To A Specified Reference Sequence. |
| Target Area | Human Peripheral Whole Blood Or Clinical Samples |
| Regulation Description | Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Gene Mutation Detection System. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Pathology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
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| Submission Type | 510(k) |
| CFR Regulation Number | 866.5900 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PFS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |