NTI · Class II · 21 CFR 862.3360

FDA Product Code NTI: Drug Metabolizing Enzyme Genotyping Systems

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.

Leading manufacturers include Luminex Molecular Diagnostics, Inc. and Genomadix, Inc..

11
Total
10
Cleared
166d
Avg days
2004
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Drug Metabolizing Enzyme Genotyping Systems Devices (Product Code NTI)

11 devices
1–11 of 11
Cleared Mar 21, 2023
Genomadix Cube CYP2C19 System
K220026
Genomadix, Inc.
Toxicology · 440d
Cleared Aug 11, 2017
xTAG CYP2D6 Kit v3
K170492
Luminex Molecular Diagnostics, Inc.
Toxicology · 175d

About Product Code NTI - Regulatory Context

510(k) Submission Activity

11 total 510(k) submissions under product code NTI since 2004, with 10 receiving FDA clearance (average review time: 166 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

NTI devices are reviewed by the Toxicology panel. Browse all Toxicology devices →