Cleared Special

K200363 - Quidel Triage® TOX Drug Screen, 94600

K200363 is an FDA 510(k) clearance for Quidel Triage TOX Drug Screen, manufactured by Quidel Cardiovascular, Inc.. The device is a Class 2 Toxicology device with product code DKZ cleared through the Special 510(k) pathway after a 26-day FDA review.

K200363 · Quidel Cardiovascular, Inc. · Toxicology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2020
Decision
26d
Days
Class 2
Risk

K200363 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 March 11, 2020 after a review of 26 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K200363

510(k) Number K200363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2020
Decision Date March 11, 2020
Days to Decision 26 days
Submission Type Special
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
61d faster than avg
Panel avg: 87d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

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 224
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K200363 · Quidel Triage® TOX Drug Screen, 94600
Download PDF FDA Summary Quidel Cardiovascular…