Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
PQP · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
FDA Product Code
PQP
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
—
Review panel
PA
Medical specialty
Unknown
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.