Cleared Special

K010650 - AT HOME DRUG TEST, MODEL 9073 T

K010650 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 25-day FDA review.

K010650 · Phamatech · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
25d
Days
Class 2
Risk

K010650 is an FDA 510(k) clearance for the AT HOME DRUG TEST, MODEL 9073 T. 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 March 30, 2001 after a review of 25 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 - K010650

510(k) Number K010650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2001
Decision Date March 30, 2001
Days to Decision 25 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
62d faster than avg
Panel avg: 87d · This submission: 25d
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 117
Devices cleared under the same product code (DIO) and FDA review panel - the closest regulatory comparables to K010650.
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
AT WORK DRUG TEST, MODEL 9177T AWT
K010833 · Phamatech · Apr 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
COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA
K001197 · OraSure Technologies, Inc. · May 2000