Cleared Special

K994237 - AT HOME DRUG TEST, MODEL 9063

K994237 is an FDA 510(k) clearance for AT HOME DRUG TEST, manufactured by Phamatech. The device is a Class 2 Toxicology device with product code DKZ cleared through the Special 510(k) pathway after a 14-day FDA review.

K994237 · Phamatech · Toxicology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
14d
Days
Class 2
Risk

K994237 is an FDA 510(k) clearance for the AT HOME DRUG TEST, MODEL 9063. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Phamatech (San Diego, US). The FDA issued a Cleared decision on December 30, 1999 after a review of 14 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 - K994237

510(k) Number K994237 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1999
Decision Date December 30, 1999
Days to Decision 14 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
73d faster than avg
Panel avg: 87d · This submission: 14d
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
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K994237.
URINE AMPHETAMINE/METHAMPHETAMINE (AMPH) SCREEN FLEX REAGENT, CATALOG NO. DF 90A
K000460 · Dade Behring, Inc. · Apr 2000
STC AMPHETAMINE-SPECIFIC INTERCEPT MICRO-PLATE EIA, MODEL 1103I
K992918 · OraSure Technologies, Inc. · Apr 2000
IMMULITE AMPHETAMINE, MODELS LKAM1, LKAM5
K992632 · Diagnostic Products Corp. · Jan 2000
DBSET MULTIDRUG SCREEN TEST KIT
K990681 · Ameritek, Inc. · Jul 1999
MODIFICATION TO 'RAPID DRUG SCREEN' 9-PANEL
K992033 · American Bio Medica Corp. · Jun 1999
QUIKSTRIP DIPSCAN X MULTIDRUG SCREENING DEVICE
K990325 · Syntron Bioresearch, Inc. · Jun 1999
K994237 · AT HOME DRUG TEST, MODEL 9063
Download PDF FDA Summary Phamatech