Cleared Special

K010833 - AT WORK DRUG TEST

K010833 is the FDA 510(k) clearance for AT WORK DRUG TEST by Phamatech. It is a Class 2 Toxicology device (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)
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.

View all Phamatech devices

Submission Details

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.

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 K010833.
COCAINE
K013004 · Abbott Laboratories · Mar 2002
ACON COC ONE STEP COCAINE TEST STRIP, ACON COC ONE STEP COCAINE TEST DEVICE
K010841 · ACON Laboratories, Inc. · Jul 2001
COCAINE DIPSTICK TEST, MODEL D747-A
K010239 · Teco Diagnostics · Jun 2001
AT HOME DRUG TEST, MODEL 9073 T
K010650 · Phamatech · Mar 2001
INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE DIP STRIP TEST
K994403 · Alfa Scientific Designs, Inc. · Aug 2000
INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE CASSETTE TEST
K994398 · Alfa Scientific Designs, Inc. · Jul 2000