Cleared Special

K010836 - AT WORK DRUG TEST, MODEL 9147T AWT

K010836 is an FDA 510(k) clearance for AT WORK DRUG TEST, manufactured by Phamatech. The device is a Class 2 Toxicology device with product code LAF cleared through the Special 510(k) pathway after a 22-day FDA review.

K010836 · Phamatech · Toxicology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
22d
Days
Class 2
Risk

K010836 is an FDA 510(k) clearance for the AT WORK DRUG TEST, MODEL 9147T AWT. Classified as Gas Chromatography, Methamphetamine (product code LAF), Class II - Special Controls.

Submitted by Phamatech (San Diego, US). The FDA issued a Cleared decision on April 11, 2001 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3610 - 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 - K010836

510(k) Number K010836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2001
Decision Date April 11, 2001
Days to Decision 22 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
65d faster than avg
Panel avg: 87d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

LAF Device Classification - Class 2, Special Controls

Product Code LAF Gas Chromatography, Methamphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3610
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 - LAF Gas Chromatography, Methamphetamine

All 48
Devices cleared under the same product code (LAF) and FDA review panel - the closest regulatory comparables to K010836.
MODIFICATION TO INSTANT-VIEW METHAMPHETAMINE (METH 1000) URINE TEST (DIP STRIP)
K003845 · Alfa Scientific Designs, Inc. · May 2001
MODIFICATION TO INSTANT-VIEW METHAMPHETYAMINE (METH1000) URINE TEST (CASSETTE)
K003847 · Alfa Scientific Designs, Inc. · May 2001
CEDIA DAU AMPHETAMINES/ECSTASY ASSAY
K010496 · Microgenics Corp. · May 2001
ESCREEN SYSTEM
K003352 · Escreen, Inc. · Mar 2001
FIRST CHECK HOME DRUG TEST PANEL 4
K993852 · Worldwide Medical Corp. · Nov 2000
ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686
K000096 · Roche Diagnostics Corp. · Apr 2000
K010836 · AT WORK DRUG TEST, MODEL 9147T AWT
Download PDF FDA Summary Phamatech