Cleared Traditional

K252550 - SAFElife T-Cup Multi-Drug Urine Test Cup (FDA 510(k) Clearance)

Also includes:
SAFElife T-Cup Multi-Drug Urine Test Cup Dx

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

K252550 · Guangzhou Wondfo Biotech Co., Ltd. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2025
Decision
97d
Days
Class 2
Risk

K252550 is an FDA 510(k) clearance for the SAFElife T-Cup Multi-Drug Urine Test Cup. Classified as Test, Amphetamine, Over The Counter (product code NFT), Class II - Special Controls.

Submitted by Guangzhou Wondfo Biotech Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on November 18, 2025 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3100 - 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 Wondfo Biotech Co., Ltd. devices

Submission Details

510(k) Number K252550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2025
Decision Date November 18, 2025
Days to Decision 97 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
10d slower than avg
Panel avg: 87d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NFT Test, Amphetamine, Over The Counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3100
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 - NFT Test, Amphetamine, Over The Counter

All 28
Devices cleared under the same product code (NFT) and FDA review panel - the closest regulatory comparables to K252550.
SAFElife T-Dip Multi-Drug Urine Test Panel
K260065 · Guangzhou Wondfo Biotech Co., Ltd. · Apr 2026
Webest Multi-Drug Urine Cup
K260355 · WEBEST Biotech,, LLC · Mar 2026
VINScreen Urine Drug Test Cup
K252867 · Advin Biotech, Inc. · Oct 2025
Wisdiag Multi-Drug Urine Test Cup
K252554 · Vivachek Biotech (Hangzhou) Co., Ltd. · Sep 2025
CLUNGENE Multi-Drug Test Easy Cup
K252118 · Hangzhou Clongene Biotech Co., Ltd. · Aug 2025
AssureTech Quick Cup Tests
K252259 · Assure Tech., LLC · Aug 2025