Cleared Traditional

K252554 - Wisdiag Multi-Drug Urine Test Cup (FDA 510(k) Clearance)

Also includes:
Wisdiag Multi-Drug Urine Home Test Cup

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

K252554 · Vivachek Biotech (Hangzhou) Co., Ltd. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2025
Decision
30d
Days
Class 2
Risk

K252554 is an FDA 510(k) clearance for the Wisdiag Multi-Drug Urine Test Cup. Classified as Test, Amphetamine, Over The Counter (product code NFT), Class II - Special Controls.

Submitted by Vivachek Biotech (Hangzhou) Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on September 12, 2025 after a review of 30 days - a notably fast clearance cycle.

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: 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 Vivachek Biotech (Hangzhou) Co., Ltd. devices

Submission Details

510(k) Number K252554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2025
Decision Date September 12, 2025
Days to Decision 30 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
57d faster than avg
Panel avg: 87d · This submission: 30d
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 Consultant

LSI International, Inc.
Jenny Xia

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 - 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 K252554.
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
SAFElife T-Cup Multi-Drug Urine Test Cup
K252550 · Guangzhou Wondfo Biotech Co., Ltd. · Nov 2025
VINScreen Urine Drug Test Cup
K252867 · Advin Biotech, Inc. · Oct 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