Cleared Traditional

ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control

K153596 · ARK Diagnostics, Inc. · Toxicology
Aug 2016
Decision
237d
Days
Class 2
Risk

About This 510(k) Submission

K153596 is an FDA 510(k) clearance for the ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control, a Enzyme Immunoassay, Oxcarbazepine Metabolite (Class II — Special Controls, product code POX), submitted by ARK Diagnostics, Inc. (Fremont, US). The FDA issued a Cleared decision on August 9, 2016, 237 days after receiving the submission on December 16, 2015. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3645.

Submission Details

510(k) Number K153596 FDA.gov
FDA Decision Cleared SESE
Date Received December 16, 2015
Decision Date August 09, 2016
Days to Decision 237 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code POX — Enzyme Immunoassay, Oxcarbazepine Metabolite
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3645
Definition An Oxcarbazepine Metabolite Assay Is An Enzyme Immunoassay Intended For The Quantitative Determination Of Oxcarbazepine Metabolite In Human Serum. The Measurements Obtained Are Used In Monitoring Levels Of Oxcarbazepine Metabolite To Help Ensure Appropriate Therapy.