Cleared Special

K994219 - AT HOME DRUG TEST

K994219 is the FDA 510(k) clearance for AT HOME DRUG TEST by Phamatech. It is a Class 2 Toxicology device (product code DIO) cleared through the Special 510(k) pathway after a 15-day FDA review.

K994219 · Phamatech · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
15d
Days
Class 2
Risk

K994219 is an FDA 510(k) clearance for the AT HOME DRUG TEST, MODEL 9073. Classified as Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO), 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 862.3250 - 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 K994219 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 DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3250
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 - DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

All 82
Devices cleared under the same product code (DIO) and FDA review panel - the closest regulatory comparables to K994219.
URINE COCAINE METABOLITE (COC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A
K000467 · Dade Behring, Inc. · Apr 2000
ONTRAK TESTSTIK 3 FOR COCAINE/MORPHINE/THC,CAT. 1118595
K994165 · Roche Diagnostics Corp. · Apr 2000
SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029UL
K993988 · Syva Co. · Jan 2000
MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE
K983697 · Roche Diagnostic Systems, Inc. · Dec 1998
ONTRAK TESTCUP-ER
K983388 · Roche Diagnostic Systems, Inc. · Nov 1998
IMMULITE COCAINE METABOLITE
K963918 · Diagnostic Products Corp. · Apr 1997