Cleared Traditional

K012745 - TRIAGE TOX DRUG SCREEN, CATALOG #94000

K012745 is an FDA 510(k) clearance for TRIAGE TOX DRUG SCREEN, manufactured by Biosite Incorporated. The device is a Class 2 Toxicology device with product code DKZ cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K012745 · Biosite Incorporated · Toxicology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
147d
Days
Class 2
Risk

K012745 is an FDA 510(k) clearance for the TRIAGE TOX DRUG SCREEN, CATALOG #94000. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Biosite Incorporated (San Diego, US). The FDA issued a Cleared decision on January 10, 2002 after a review of 147 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3100 - 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.

FDA 510(k) Submission Details - K012745

510(k) Number K012745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2001
Decision Date January 10, 2002
Days to Decision 147 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
60d slower than avg
Panel avg: 87d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DKZ Device Classification - Class 2, Special Controls

Product Code DKZ Enzyme Immunoassay, Amphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3100
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 - DKZ Enzyme Immunoassay, Amphetamine

All 224
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K012745.
AMPHETAMINES ENZYME IMMUNOASSAY, CATALOG #0040 (500 TESTS KIT), CATALOG #0041 (5000 TESTS KIT)
K020395 · Lin-Zhi International, Inc. · Jun 2002
TRIAGE DRUGS OF ABUSE PANEL PLUS PPX, MODEL CATALOG 92002
K014247 · Biosite Incorporated · Jun 2002
ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD
K020313 · Acon Laboratories Co. · May 2002
AMEDITECH IMMUTEST DRUG SCREEN AMPHETAMINE
K012484 · Ameditech, Inc. · Nov 2001
ONTRAK TESTCARD 9
K012396 · Roche Diagnostics Corp. · Nov 2001
DRUGS OF ABUSE MULTI-TEST STRIP
K011952 · Microdiagnostics, Inc. · Oct 2001
K012745 · TRIAGE TOX DRUG SCREEN, CATALOG #94000
Download PDF FDA Summary Biosite Incorporated