Cleared Special

K994219 - AT HOME DRUG TEST, MODEL 9073

K994219 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 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

FDA 510(k) Submission Details - K994219

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.

DIO Device Classification - Class 2, Special Controls

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 116
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
VISUALINE V DRUGS OF ABUSE DIPSTRIP PANEL FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPE
K993485 · Sun Biomedical Laboratories, Inc. · Dec 1999
QUICKPAC II ONE STEP COCAINE TEST
K992990 · Syntron Bioresearch, Inc. · Sep 1999
DRUGCHECK X MULTIDRUG SCREENING DEVICE
K992748 · Syntron Bioresearch, Inc. · Sep 1999