Drug Metabolizing Enzyme Genotyping Systems

NTI is the FDA product code for Drug Metabolizing Enzyme Genotyping Systems, a class II device type, regulated under 21 CFR 862.3360. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold 11 510(k) clearances under this code, the most recent dated 2023-03-21, and 4 recalls.