Cleared Traditional

AllTest Multi-Drug Urine Test Cup (K241428) - FDA 510(k) Clearance

Also marketed or referenced as:
AllTest Multi-Drug Rapid Urine Test Cup

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

K241428 · Hangzhou AllTest Biotech Co., Ltd. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2024
Decision
28d
Days
Class 2
Risk

K241428 is an FDA 510(k) clearance for the AllTest Multi-Drug Urine Test Cup. Classified as Test, Amphetamine, Over The Counter (product code NFT), Class II - Special Controls.

Submitted by Hangzhou AllTest Biotech Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on June 17, 2024 after a review of 28 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 Hangzhou AllTest Biotech Co., Ltd. devices

Submission Details

510(k) Number K241428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2024
Decision Date June 17, 2024
Days to Decision 28 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
59d faster than avg
Panel avg: 87d · This submission: 28d
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 K241428.
Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTC
K242498 · Aicheck Biotech, Inc. · Oct 2024
AllTest Multi-Drug Urine Test Panel
K242540 · Hangzhou AllTest Biotech Co., Ltd. · Sep 2024
PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup
K242077 · Aicheck Biotech, Inc. · Aug 2024
BioSieveTM Multi-Drug Urine Test Panel
K233062 · Vivachek Biotech (Hangzhou) Co., Ltd. · Nov 2023
Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx
K222667 · Vivachek Biotech (Hangzhou) Co., Ltd. · Nov 2022
Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx
K221871 · Healstone Biotech, Inc. · Aug 2022