Cleared Traditional

ARK Fentanyl II Assay (K200197) - FDA 510(k) Clearance

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

K200197 · ARK Diagnostics, Inc. · Toxicology device
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Feb 2020
Decision
30d
Days
Class 2
Risk

K200197 is an FDA 510(k) clearance for the ARK Fentanyl II 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 February 26, 2020 after a review of 30 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all ARK Diagnostics, Inc. devices

Submission Details

510(k) Number K200197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2020
Decision Date February 26, 2020
Days to Decision 30 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
57d faster than avg
Panel avg: 87d · This submission: 30d
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 K200197.
LZI Oxycodone III Enzyme Immunoassay
K202007 · Lin-Zhi International, Inc. · Sep 2020
LZI Fentanyl II Enzyme Immunoassay
K201938 · Lin-Zhi International, Inc. · Aug 2020
LZI Tramadol Enzyme Immunoassay
K201223 · Lin-Zhi International, Inc. · Jun 2020
CEDIA Heroin Metabolite (6-AM) assay
K192943 · Microgenics Corporation · Dec 2019
Psychemedics Microplate EIA for Fentanyl in Hair
K182103 · Psychemedics Corporation · Apr 2019
ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card
K182123 · Advin Biotech, Inc. · Mar 2019