Cleared Traditional

ARK Fentanyl Assay (K180427) - FDA 510(k) Clearance

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

K180427 · ARK Diagnostics, Inc. · Toxicology device
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Jun 2018
Decision
110d
Days
Class 2
Risk

K180427 is an FDA 510(k) clearance for the ARK Fentanyl Assay. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by ARK Diagnostics, Inc. (Fremont, US). The FDA issued a Cleared decision on June 6, 2018 after a review of 110 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3650 - 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 K180427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2018
Decision Date June 06, 2018
Days to Decision 110 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 87d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DJG Enzyme Immunoassay, Opiates
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3650
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.

Regulatory Peers - DJG Enzyme Immunoassay, Opiates

All 88
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K180427.
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K181159 · Lin-Zhi International, Inc. · Dec 2018
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K172416 · Infrared Laboratory Systems, LLC (Dba Synermed) · Apr 2018
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K173195 · Microgenics Corporation · Feb 2018
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