Cleared Traditional

K182280 - ARK Tramadol Assay

K182280 is an FDA 510(k) clearance for ARK Tramadol Assay, manufactured by ARK Diagnostics, Inc.. The device is a Class 2 Toxicology device with product code DJG cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K182280 · ARK Diagnostics, Inc. · Toxicology device
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Dec 2018
Decision
110d
Days
Class 2
Risk

K182280 is an FDA 510(k) clearance for the ARK Tramadol 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 December 10, 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

FDA 510(k) Submission Details - K182280

510(k) Number K182280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2018
Decision Date December 10, 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.

DJG Device Classification - Class 2, Special Controls

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 149
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