Cleared Traditional

K242428 - Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus (FDA 510(k) Clearance)

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

K242428 · Guangzhou Decheng Biotechnology Co., Ltd. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2025
Decision
175d
Days
Class 2
Risk

K242428 is an FDA 510(k) clearance for the Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Do.... Classified as Test, Opiates, Over The Counter (product code NGL), Class II - Special Controls.

Submitted by Guangzhou Decheng Biotechnology Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on February 6, 2025 after a review of 175 days - an extended review 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: 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 Guangzhou Decheng Biotechnology Co., Ltd. devices

Submission Details

510(k) Number K242428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2024
Decision Date February 06, 2025
Days to Decision 175 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
88d slower than avg
Panel avg: 87d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NGL Test, Opiates, Over The Counter
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 - NGL Test, Opiates, Over The Counter

All 22
Devices cleared under the same product code (NGL) and FDA review panel - the closest regulatory comparables to K242428.
Healgen Accurate Urine Drug Screen Dip Card
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Deepblue Multi-Drug Urine Test Cup
K250803 · Anhui Deepblue Medical Technological Co., Ltd. · Apr 2025
Dochek® Multi-Drug Urine Test Cup
K250067 · Guangzhou Decheng Biotechnology Co., Ltd. · Feb 2025
Healgen Accurate Muti-Drug Urine Drug Screen Cup
K243365 · Healgen Scientific, LLC · Dec 2024
ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold)
K243064 · Eterbio, Inc. · Nov 2024
CLUNGENE Fentanyl Home Test Cassette
K242802 · Hangzhou Clongene Biotech Co., Ltd. · Nov 2024