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 Te
| Device Type ID | 4923 |
| Device Name | System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection |
| 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 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 | PFR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |