Cleared Traditional

SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card (K201120) - FDA 510(k) Clearance

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

K201120 · Safecare Biotech (Hangzhou) Co., Ltd. · Toxicology device
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Optimized for regulatory review, auditing and printing
May 2020
Decision
30d
Days
Class 2
Risk

K201120 is an FDA 510(k) clearance for the SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card. Classified as Test, Amphetamine, Over The Counter (product code NFT), Class II - Special Controls.

Submitted by Safecare Biotech (Hangzhou) Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on May 27, 2020 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 Safecare Biotech (Hangzhou) Co., Ltd. devices

Submission Details

510(k) Number K201120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2020
Decision Date May 27, 2020
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
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 K201120.
HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup Rx
K220685 · Qingdao Hightop Biotech Co., Ltd. · May 2022
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
Accurate Multi Panel Drug Urine Test Cup
K191841 · Healstone Biotech, Inc. · Aug 2019
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