Cleared Traditional

K222667 - Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx (FDA 510(k) Clearance)

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

K222667 · Vivachek Biotech (Hangzhou) Co., Ltd. · Toxicology device
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Nov 2022
Decision
65d
Days
Class 2
Risk

K222667 is an FDA 510(k) clearance for the Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx. 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 November 10, 2022 after a review of 65 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 K222667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2022
Decision Date November 10, 2022
Days to Decision 65 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
22d faster than avg
Panel avg: 87d · This submission: 65d
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
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 - 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 K222667.
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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
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