Cleared Abbreviated

Genomadix Cube CYP2C19 System

K220026 · Genomadix, Inc. · Toxicology

Mar 2023

Decision

440d

Days

Class 2

Risk

About This 510(k) Submission

K220026 is an FDA 510(k) clearance for the Genomadix Cube CYP2C19 System, a Drug Metabolizing Enzyme Genotyping Systems (Class II — Special Controls, product code NTI), submitted by Genomadix, Inc. (Kanata (Ottawa), CA). The FDA issued a Cleared decision on March 21, 2023, 440 days after receiving the submission on January 5, 2022. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3360.

Submission Details

510(k) Number	K220026 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 05, 2022
Decision Date	March 21, 2023
Days to Decision	440 days
Submission Type	Abbreviated
Review Panel	Toxicology (TX)
Summary	Summary PDF

Device Classification

Product Code	NTI — Drug Metabolizing Enzyme Genotyping Systems
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.3360
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.