High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids
SBY · Class II — Moderate Risk (510(k) clearance required) · Pathology · 21 CFR 866.6085
Classification
FDA Product Code
SBY
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.6085
Review panel
PA
Medical specialty
Pathology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
A high throughput sequencing based tumor profiling test of circulating cell-free nucleic acids is a qualitative in vitro diagnostic test intended for next generation sequencing analysis of circulating cell-free nucleic acids from plasma samples collected from peripheral whole blood to detect mutations in a panel of targeted genes to aid in the management of previously diagnosed cancer patients by qualified health care professionals. The results of the test are not prescriptive or conclusive for use of any specific therapeutic product.