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U.S. Department of Health and Human Services

Product Classification

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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 CodePSU
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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible