Cleared Traditional

K182738 - Single and Multi-Drug Rapid Test Panel ...

K182738 is an FDA 510(k) clearance for Single and Multi-Drug Rapid Test Panel ..., manufactured by Hangzhou AllTest Biotech Co., Ltd.. The device is a Class 2 Toxicology device with product code DKZ cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K182738 · Hangzhou AllTest Biotech Co., Ltd. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2019
Decision
180d
Days
Class 2
Risk

K182738 is an FDA 510(k) clearance for the Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and .... Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Hangzhou AllTest Biotech Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on March 27, 2019 after a review of 180 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hangzhou AllTest Biotech Co., Ltd. devices

FDA 510(k) Submission Details - K182738

510(k) Number K182738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2018
Decision Date March 27, 2019
Days to Decision 180 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
93d slower than avg
Panel avg: 87d · This submission: 180d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DKZ Device Classification - Class 2, Special Controls

Product Code DKZ Enzyme Immunoassay, Amphetamine
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

Ivdd Regulatory Consultant
Feng-Yu Lee

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 - DKZ Enzyme Immunoassay, Amphetamine

All 140
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K182738.
Quidel Triage® TOX Drug Screen, 94600
K200363 · Quidel Cardiovascular, Inc. · Mar 2020
Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel
K191099 · Atlas Medical · Oct 2019
Quidel Triage TOX Drug Screen, 94600
K182719 · Quidel Cardiovascular, Inc. · Jun 2019
BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use
K180879 · Shanghai Venture Bio-Tech Co., Ltd. · Dec 2018
QuickScreen Pro Multi Drug Screening Test, Model 9395Z
K181945 · Phamatech, Inc. · Oct 2018
INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)
K173303 · Alfa Scientific Designs, Inc. · Feb 2018