Not Cleared Direct

DEN160033 - ARK Voriconazole II Assay Test System (FDA 510(k) Clearance)

Class II Toxicology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN160033 · ARK Diagnostics, Inc. · Toxicology device
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May 2017
Decision
294d
Days
Class 2
Risk

DEN160033 is an FDA 510(k) submission (not cleared) for the ARK Voriconazole II Assay Test System. Classified as Voriconazole Test System (product code PUJ), Class II - Special Controls.

Submitted by ARK Diagnostics, Inc. (Fremont, US). The FDA issued a Not Cleared (DENG) decision on May 5, 2017 after a review of 294 days.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3970 - the FDA toxicology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. Elevated predicate reliance profile. With 294 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all ARK Diagnostics, Inc. devices

Submission Details

510(k) Number DEN160033 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received July 15, 2016
Decision Date May 05, 2017
Days to Decision 294 days
Submission Type Direct
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
207d slower than avg
Panel avg: 87d · This submission: 294d
Pathway characteristics

Device Classification

Product Code PUJ Voriconazole Test System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3970
Definition A Voriconazole Test System Is A Device Intended To Measure Voriconazole In Human Serum. Measurements Obtained By This Device Are Used In Monitoring Levels Of Voriconazole To 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.