NTI

Drug Metabolizing Enzyme Genotyping Systems

Product code

NTI

Device name

Drug Metabolizing Enzyme Genotyping Systems

Device class

Class 2

21 CFR

21 CFR 862.3360

Medical specialty

Clinical Toxicology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

11 (all years; only the last 3 years are listed here)

FDA classification definition

Intended to identify the presence or absence of human genotypic markers encoding drug metaboizing enzymes using dna originating from clinical samples. This type of assay can be used as an aid determining treatment choice and individualizing treatment dose for therapeutics that are metabolized primarily by the specific enzyme tested by the system.

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