Cleared Traditional

TruDiagnosis System

K183530 · Akonni Biosystems, Inc. · Toxicology

May 2019

Decision

156d

Days

Class 2

Risk

About This 510(k) Submission

K183530 is an FDA 510(k) clearance for the TruDiagnosis System, a Cytochrome P450 2c9 (cyp450 2c9) Drug Metabolizing Enzyme Genotyping System (Class II — Special Controls, product code ODW), submitted by Akonni Biosystems, Inc. (Frederick, US). The FDA issued a Cleared decision on May 24, 2019, 156 days after receiving the submission on December 19, 2018. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3360.

Submission Details

510(k) Number	K183530 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 19, 2018
Decision Date	May 24, 2019
Days to Decision	156 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF

Device Classification

Product Code	ODW — Cytochrome P450 2c9 (cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.3360
Definition	An In Vitro Diagnostic Assay For Use In Genotyping Cytochrome P450 2c9 (cyp450 2c9) Alleles. Information About The Cyp2c9 Genotype May Be Used As An Aid To Clinicians In Determining Therapeutic Strategy For Medications That Are Metabolized By The Cyp2c9 Gene Product.