Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
The Next Generation Sequencing Oncology Panel, Somatic or Germline Variant Detection System is a molecular diagnostic device used for the qualitative detection of germline or somatic variants in one or more cancer-related genes from DNA or RNA isolated from human clinical specimens, supporting oncology diagnosis and treatment decisions. It is classified as FDA Class 3, requiring Premarket Approval (PMA), reflecting the high risk of the device given its use in guiding cancer care. The device is reviewed by the Pathology panel. Product code PQP; no regulation number assigned; not an implant and not life-sustaining.
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Basic Information
- Product Code
- PQP
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- PA
- Submission Type
- 2
Device Characteristics
Definition
A next generation sequencing (NGS) oncology panel is a device used for the qualitative detection of germline or somatic variants in one or more cancer-related genes. The device is intended to be used on DNA or RNA isolated from human clinical specimens.
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.