Cleared Traditional

K191099 - Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel

K191099 is an FDA 510(k) clearance for Atlas Multi-Drugs Screening Test Cup, manufactured by Atlas Medical. The device is a Class 2 Toxicology device with product code DKZ cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K191099 · Atlas Medical · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2019
Decision
161d
Days
Class 2
Risk

K191099 is an FDA 510(k) clearance for the Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Atlas Medical (Amman, JO). The FDA issued a Cleared decision on October 3, 2019 after a review of 161 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 Atlas Medical devices

FDA 510(k) Submission Details - K191099

510(k) Number K191099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2019
Decision Date October 03, 2019
Days to Decision 161 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
74d slower than avg
Panel avg: 87d · This submission: 161d
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 Peers - DKZ Enzyme Immunoassay, Amphetamine

All 184
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K191099.
AllTest Multi-Drug Rapid Test Cup
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Quidel Triage® TOX Drug Screen, 94600
K200363 · Quidel Cardiovascular, Inc. · Mar 2020
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K182719 · Quidel Cardiovascular, Inc. · Jun 2019
Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine)
K182738 · Hangzhou AllTest Biotech Co., Ltd. · Mar 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