Cleared Special

K010833 - AT WORK DRUG TEST, MODEL 9177T AWT

K010833 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 DIO cleared through the Special 510(k) pathway after a 22-day FDA review.

K010833 · 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

K010833 is an FDA 510(k) clearance for the AT WORK DRUG TEST, MODEL 9177T AWT. 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 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 862.3250 - 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.

FDA 510(k) Submission Details - K010833

510(k) Number K010833 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.

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 144
Devices cleared under the same product code (DIO) and FDA review panel - the closest regulatory comparables to K010833.
COCAINE DIPSTICK TEST, MODEL D747-A
K010239 · Teco Diagnostics · Jun 2001
MODIFICATION TO THE EMIT II PLUS COCAINE METABOLITE ASSAY
K011162 · Syva Co., Dade Behring, Inc. · May 2001
LIVESURE COCAINE SCREEN TEST
K010967 · Pan Probe Biotech, Inc. · Apr 2001
AT HOME DRUG TEST, MODEL 9073 T
K010650 · Phamatech · Mar 2001
ADVANTAGE THC/COCAINE TEST
K003708 · Advantage Diagnostics Corp. · Jan 2001
BRANAN MEDICAL CORPORATION MONITECT COCAINE DRUG SCREEN TEST
K002264 · Branan Medical Corporation · Nov 2000
K010833 · AT WORK DRUG TEST, MODEL 9177T AWT
Download PDF FDA Summary Phamatech