Cleared Traditional

K252550 - SAFElife T-Cup Multi-Drug Urine Test Cup

Also marketed or referenced as:
SAFElife T-Cup Multi-Drug Urine Test Cup Dx

K252550 is an FDA 510(k) clearance for SAFElife T-Cup Multi-Drug Urine Test Cup, manufactured by Guangzhou Wondfo Biotech Co., Ltd.. The device is a Class 2 Toxicology device with product code NFT cleared through the Traditional 510(k) pathway after a 97-day FDA review.

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

FDA 510(k) Submission Details - K252550

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.

NFT Device Classification - Class 2, Special Controls

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 30
Devices cleared under the same product code (NFT) and FDA review panel - the closest regulatory comparables to K252550.
BioSieve Multi-Drug Urine Test Panel
K261280 · Vivachek Biotech (Hangzhou) Co., Ltd. · May 2026
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