Cleared Traditional

K241741 - SAFElife™ Fentanyl Urine Home Test (Cassette) (FDA 510(k) Clearance)

Also includes:
SAFElife™ Fentanyl (FTY) Urine Test Cassette SAFElife™ T-Dip Fentanyl Urine Home Test (Dip Card) SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel

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

K241741 · Guangzhou Wondfo Biotech Co., Ltd. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2024
Decision
29d
Days
Class 2
Risk

K241741 is an FDA 510(k) clearance for the SAFElife™ Fentanyl Urine Home Test (Cassette). Classified as Test, Opiates, Over The Counter (product code NGL), Class II - Special Controls.

Submitted by Guangzhou Wondfo Biotech Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on July 16, 2024 after a review of 29 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 Guangzhou Wondfo Biotech Co., Ltd. devices

Submission Details

510(k) Number K241741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2024
Decision Date July 16, 2024
Days to Decision 29 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
58d faster than avg
Panel avg: 87d · This submission: 29d
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 Consultant

LSI International, Inc.
Joe Shia

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K241741.
Healgen Accurate Urine Drug Screen Dip Card
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Deepblue Multi-Drug Urine Test Cup
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Dochek® Multi-Drug Urine Test Cup
K250067 · Guangzhou Decheng Biotechnology Co., Ltd. · Feb 2025
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
K242428 · 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