Product code SBY

Device name

High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids

Medical specialty

Pathology

Device class

2

Regulation number

866.6085

Review panel

PA

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset