Cleared Special

K013408 - AT HOME DRUG TEST, MODEL 9079 (FDA 510(k) Clearance)

Class II Toxicology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K013408 · Phamatech, Inc. · Toxicology device
Dec 2001
Decision
52d
Days
Class 2
Risk

K013408 is an FDA 510(k) clearance for the AT HOME DRUG TEST, MODEL 9079. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Phamatech, Inc. (San Diego, US). The FDA issued a Cleared decision on December 6, 2001 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3650 - 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.

Submission Details

510(k) Number K013408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2001
Decision Date December 06, 2001
Days to Decision 52 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 146d · This submission: 52d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DJG Enzyme Immunoassay, Opiates
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3650
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 - DJG Enzyme Immunoassay, Opiates

All 25
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