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 Fibros
| Device Type ID | 4920 |
| Device Name | System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection |
| Physical State | Multiplex Qualitative Amplification Based Detection System. Should Not Include Devices Which Use Sequencing Based Detection Methods. |
| Technical Method | Uses Multiplex Polymerase Chain Reaction To Amplify Specific DNA Variants Located On The CFTR Gene Using Non-sequencing Based Methods. |
| 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) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.5900 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NUA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4920 |
| Device | System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection |
| Product Code | NUA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Gene Mutation Detection System. |
| CFR Regulation Number | 866.5900 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
LUMINEX CORPORATION | ||
SUBSTANTIALLY EQUIVALENT - KIT | 2 | |
LUMINEX MOLECULAR DIAGNOSTICS | ||
SUBSTANTIALLY EQUIVALENT - KIT | 2 | |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Hologic, Inc | II | Apr-27-2016 |