Product Classification

• Device: jak2 gene mutation detection test
• 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.
• 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
• Product Code: PSU
• Premarket Review: Division of Molecular Genetics and Pathology (DMGP); Division of Molecular Genetics and Pathology (DMGP)
• Submission Type: 510(k)
• Regulation Number: 866.6070
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

Not Third Party Eligible