DeviceClearance

Product code SBY— Pathology

Oncomine Dx Express Test

Classification name
High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids
Device class
Class 2
Regulation
21 CFR 866.6085
Advisory panel
Pathology
Total cleared
2
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code SBY under 21 CFR 866.6085, via openFDA

Market context for product code SBY

FDA has cleared 2 devices under product code SBY between 2024 and 2026, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code SBY

Recent clearances under product code SBY

Data sourced from openFDA. This site is unofficial and independent of the FDA.