Definition: A Multiplex Genotying Test System Intended For The Qualitative Detection And Identification Of Specific Thrombophilia Related Gene Mutations From Genomic DNA By Genomic Amplification And Mass Spectrometry. It Is Intended As An Aid In Diagnosis Of Pat
| Device Type ID | 4908 |
| Device Name | System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations |
| Physical State | A Qualitative Multiplex Amplification-based Genotyping Test System. Should Not Include Any Devices Other Than Mass Spectrometry-based Detection Systems. |
| Technical Method | The Assay Uses Multiplex Polymerase Chain Reaction And Allele Specific Single Base Primer Extension Reactions To Amplify And Detect Specific Mutations Located In The Factor V And Prothrombin Genes. Genotyped Products Are Resolved According To Mass By |
| Target Area | Human Peripheral Whole Blood Or Other Clinical Samples. |
| Regulation Description | Factor V Leiden DNA Mutation Detection Systems. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Pathology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 864.7280 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PHJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4908 |
| Device | System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations |
| Product Code | PHJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Factor V Leiden DNA Mutation Detection Systems. |
| CFR Regulation Number | 864.7280 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
SEQUENOM, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |