Cleared Traditional

K010239 - COCAINE DIPSTICK TEST

K010239 is an FDA 510(k) clearance for COCAINE DIPSTICK TEST, manufactured by Teco Diagnostics. The device is a Class 2 Toxicology device with product code DIO cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K010239 · Teco Diagnostics · Toxicology device
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Jun 2001
Decision
151d
Days
Class 2
Risk

K010239 is an FDA 510(k) clearance for the COCAINE DIPSTICK TEST, MODEL D747-A. Classified as Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO), Class II - Special Controls.

Submitted by Teco Diagnostics (Anaheim, US). The FDA issued a Cleared decision on June 25, 2001 after a review of 151 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3250 - the FDA toxicology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Teco Diagnostics devices

FDA 510(k) Submission Details - K010239

510(k) Number K010239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2001
Decision Date June 25, 2001
Days to Decision 151 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 87d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 96
Devices cleared under the same product code (DIO) and FDA review panel - the closest regulatory comparables to K010239.
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COCAINE
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ACON COC ONE STEP COCAINE TEST STRIP, ACON COC ONE STEP COCAINE TEST DEVICE
K010841 · ACON Laboratories, Inc. · Jul 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
AT HOME DRUG TEST, MODEL 9073 T
K010650 · Phamatech · Mar 2001