Cleared Traditional

K013004 - COCAINE

K013004 is an FDA 510(k) clearance for COCAINE, manufactured by Abbott Laboratories. The device is a Class 2 Toxicology device with product code DIO cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K013004 · Abbott Laboratories · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
188d
Days
Class 2
Risk

K013004 is an FDA 510(k) clearance for the COCAINE. Classified as Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO), Class II - Special Controls.

Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on March 13, 2002 after a review of 188 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K013004

510(k) Number K013004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2001
Decision Date March 13, 2002
Days to Decision 188 days
Submission Type Traditional
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
101d slower than avg
Panel avg: 87d · This submission: 188d
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 95
Devices cleared under the same product code (DIO) and FDA review panel - the closest regulatory comparables to K013004.
ACON ONE STEP DRUG SCREEN TEST CARD
K020771 · ACON Laboratories, Inc. · May 2002
COCAINE METABOLITE ENZYME IMMUNOASSAY MODELS #0030 (500 TESTS KIT), #0031 (5000 TESTS KIT)
K020763 · Lin-Zhi International, Inc. · May 2002
EMIT II PLUS MONOCLONAL COCAINE METABOLITE ASSAY
K020441 · Dade Behring, Inc. · 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 WORK DRUG TEST, MODEL 9177T AWT
K010833 · Phamatech · Apr 2001