Cleared Traditional

K153596 - ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control (FDA 510(k) Clearance)

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K153596 is an FDA 510(k) clearance for the ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, .... Classified as Enzyme Immunoassay, Oxcarbazepine Metabolite (product code POX), Class II - Special Controls.

Submitted by ARK Diagnostics, Inc. (Fremont, US). The FDA issued a Cleared decision on August 9, 2016 after a review of 237 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3645 - the FDA toxicology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all ARK Diagnostics, Inc. devices

Submission Details

510(k) Number K153596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
150d slower than avg
Panel avg: 87d · This submission: 237d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code POX Enzyme Immunoassay, Oxcarbazepine Metabolite
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.