Definition: The JAK2 Gene Mutation Detection System Is A Device Used To Detect Mutations And Variants In The JAK2 Gene. It Is Intended For Use As An Adjunct To Evaluation Of Suspected Polycythemia Vera, In Conjunction With Other Clinicopathological Factors.
| Device Type ID | 4928 |
| Device Name | Jak2 Gene Mutation Detection Test |
| Physical State | The Test Utilizes A Multiplex Qualitative Amplification Based Detection System. It May Also Utilize Other Technologies And/or Quantification Methods. |
| Technical Method | The Test Is A Quantitative Real Time PCR That Uses Specific Primers And Probes For Selective Amplification Of Mutant And Wild Type Alleles For Detection Of Gene Mutations. |
| Target Area | Human Peripheral Whole Blood. |
| Regulation Medical Specialty | Molecular Genetics |
| Review Panel | Pathology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.6070 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PSU |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4928 |
| Device | Jak2 Gene Mutation Detection Test |
| Product Code | PSU |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 866.6070 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
QIAGEN, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |