Cleared Traditional

Accurate Multi Panel Drug Urine Test Cup (K191841) - FDA 510(k) Clearance

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

K191841 · Healstone Biotech, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2019
Decision
29d
Days
Class 2
Risk

K191841 is an FDA 510(k) clearance for the Accurate Multi Panel Drug Urine Test Cup. Classified as Test, Amphetamine, Over The Counter (product code NFT), Class II - Special Controls.

Submitted by Healstone Biotech, Inc. (Vancouver, CA). The FDA issued a Cleared decision on August 7, 2019 after a review of 29 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 Healstone Biotech, Inc. devices

Submission Details

510(k) Number K191841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2019
Decision Date August 07, 2019
Days to Decision 29 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
58d faster than avg
Panel avg: 87d · This submission: 29d
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.
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 K191841.
SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card
K202453 · Safecare Biotech (Hangzhou) Co., Ltd. · Mar 2021
Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx
K202567 · Guangzhou Wondfo Biotech Co., Ltd. · Sep 2020
SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card
K201120 · Safecare Biotech (Hangzhou) Co., Ltd. · May 2020
Wondfo T-Cup Multi-Drug Urine Test Cup
K182701 · Guangzhou Wondfo Biotech Co., Ltd. · Dec 2018
BIOEASY Multi-Drug Test Cup
K182530 · Shenzhen Bioeasy Biotechnology Co., Ltd. · Nov 2018
AssureTech Panel Dip Tests, AssureTech Quick Cup Tests
K181768 · Assure Tech. (Hangzhou) Co, Ltd. · Aug 2018