DeviceClearance

Product code PSU— Medical Genetics

ipsogen JAK2 RGQ PCR Kit

Classification name
Jak2 Gene Mutation Detection Test
Device class
Class 2
Regulation
21 CFR 866.6070
Advisory panel
Medical Genetics
Total cleared
2
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code PSU under 21 CFR 866.6070, via openFDA

Market context for product code PSU

FDA has cleared 2 devices under product code PSU between 2017 and 2018, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PSU

Recent clearances under product code PSU

Data sourced from openFDA. This site is unofficial and independent of the FDA.