DeviceClearance

Product code NTI— Clinical Toxicology

AMPLICHIP CYP450 TEST, MODEL 04381866190

Classification name
Drug Metabolizing Enzyme Genotyping Systems
Device class
Class 2
Regulation
21 CFR 862.3360
Advisory panel
Clinical Toxicology
Total cleared
11
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code NTI under 21 CFR 862.3360, via openFDA

Market context for product code NTI

FDA has cleared 11 devices under product code NTI between 2004 and 2023, filed by 7 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 NTI

Recent clearances under product code NTI

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