Cleared Traditional

Quidel Triage TOX Drug Screen, 94600 (K182719) - FDA 510(k) Clearance

Also marketed or referenced as:
Quidel Triage® MeterPro

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

K182719 · Quidel Cardiovascular, Inc. · Toxicology device
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Jun 2019
Decision
264d
Days
Class 2
Risk

K182719 is an FDA 510(k) clearance for the Quidel Triage TOX Drug Screen, 94600. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Quidel Cardiovascular, Inc. (San Diego, US). The FDA issued a Cleared decision on June 19, 2019 after a review of 264 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 Quidel Cardiovascular, Inc. devices

Submission Details

510(k) Number K182719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2018
Decision Date June 19, 2019
Days to Decision 264 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
177d slower than avg
Panel avg: 87d · This submission: 264d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 224
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K182719.
DRI Ecstasy Plus Assay
K240670 · Microgenics Corporation · Oct 2024
AllTest Multi-Drug Rapid Test Cup
K233019 · Hangzhou AllTest Biotech Co., Ltd. · Dec 2023
Xenta Drug Screen Cup, Xenta Drug Screen Dipcard
K231137 · Xenta Biomedical Science Co., Ltd. · May 2023
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
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