Cleared Traditional

K242428 - Dochek Fentanyl Urine Test Strip

K242428 is an FDA 510(k) clearance for Dochek Fentanyl Urine Test Strip, manufactured by Guangzhou Decheng Biotechnology Co., Ltd.. The device is a Class 2 Toxicology device with product code NGL cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K242428 · Guangzhou Decheng Biotechnology Co., Ltd. · Toxicology device
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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

FDA 510(k) Submission Details - K242428

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.

NGL Device Classification - Class 2, Special Controls

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 20
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
K253567 · Healgen Scientific, LLC · Dec 2025
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