Cleared Special

K994220 - AT HOME DRUG TEST

K994220 is the FDA 510(k) clearance for AT HOME DRUG TEST by Phamatech. It is a Class 2 Toxicology device (product code LDJ) cleared through the Special 510(k) pathway after a 15-day FDA review.

K994220 · Phamatech · Toxicology device
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Optimized for regulatory review, auditing and printing
Dec 1999
Decision
15d
Days
Class 2
Risk

K994220 is an FDA 510(k) clearance for the AT HOME DRUG TEST, MODEL 9078. Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Phamatech (San Diego, US). The FDA issued a Cleared decision on December 30, 1999 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3870 - 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.

View all Phamatech devices

Submission Details

510(k) Number K994220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1999
Decision Date December 30, 1999
Days to Decision 15 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
72d faster than avg
Panel avg: 87d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LDJ Enzyme Immunoassay, Cannabinoids
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3870
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 - LDJ Enzyme Immunoassay, Cannabinoids

All 85
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K994220.
URINE CANNABINOIDS (THC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 95A
K000461 · Dade Behring, Inc. · Apr 2000
QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9153 PAT04
K000131 · Phamatech · Feb 2000
SYVA EMIT II PLUS CANNABINOID ASSAY, MODELS 9N029UL/9N129UL
K993984 · Syva Co. · Jan 2000
MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS
K983701 · Roche Diagnostic Systems, Inc. · Dec 1998
ABUSCREEN ONLINE FOR CANNABINOIDS (100 TEST KIT)
K981584 · Roche Diagnostic Systems, Inc. · May 1998
ABUSCREEN ONLINE FOR CANNABINOIDS (1000 TEST KIT)
K981585 · Roche Diagnostic Systems, Inc. · May 1998