FDA product code PSU: Jak2 Gene Mutation Detection Test
PSU is the FDA product code for jak2 gene mutation detection test. It is a Class II device, regulated under 21 CFR 866.6070 and reviewed by the Pathology panel. FDA has cleared 1 510(k) submission under PSU. The average 510(k) review took 168 days (median 168). 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Jak2 Gene Mutation Detection Test |
| Device class | Class II |
| Regulation | 21 CFR 866.6070 |
| Review panel | PA — Pathology |
| Medical specialty | Medical Genetics |
| Premarket route | 510(k) |
510(k) clearances per year for PSU
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 168 |
Compare with all 510(k) review times · Search every PSU clearance
Top PSU applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Qiagen, Inc. | 1 | 2018-01-12 |
Most recent PSU clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K172287 | Qiagen, Inc. | ipsogen JAK2 RGQ PCR Kit | 2018-01-12 | 168 |
Recalls for PSU devices
openFDA lists no recalls for product code PSU.
Frequently asked questions
What is FDA product code PSU?
PSU is the FDA product code for jak2 gene mutation detection test. It is a Class II device, regulated under 21 CFR 866.6070 and reviewed by the Pathology panel.
What device class is PSU?
Class II, regulation 21 CFR 866.6070. Typical premarket route: 510(k).
How long does a 510(k) take for product code PSU?
Across 1 cleared submissions the average was 168 days from receipt to decision (median 168).
Which companies have the most PSU clearances?
Qiagen, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PSU
- Run a recall and safety report across every PSU manufacturer
- Watch product code PSU for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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