SBY

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

Product code

SBY

Device name

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

Device class

Class 2

21 CFR

21 CFR 866.6085

Medical specialty

Pathology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-08-01.