Cleared Traditional

K003865 - COBAS INTEGRA AMPHETAMINES

K003865 is the FDA 510(k) clearance for COBAS INTEGRA AMPHETAMINES by Roche Diagnostics Corp.. It is a Class 2 Toxicology device (product code DKZ) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K003865 · Roche Diagnostics Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
77d
Days
Class 2
Risk

K003865 is an FDA 510(k) clearance for the COBAS INTEGRA AMPHETAMINES. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on February 28, 2001 after a review of 77 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Roche Diagnostics Corp. devices

Submission Details

510(k) Number K003865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2000
Decision Date February 28, 2001
Days to Decision 77 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
10d faster than avg
Panel avg: 87d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 96
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K003865.
DRI ECSTASY ENZYME IMMUNOASSAY
K012110 · Microgenics Corp. · Aug 2001
EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229
K012257 · Syva Co. · Aug 2001
ACON AMP ONE STEP AMPHETAMINE TEST STRIP, ACON AMP ONE STEP AMPHETAMINE TEST DEVICE
K011673 · ACON Laboratories, Inc. · Jul 2001
ONTRAK TESTCUP 501, MODEL 3016633
K001421 · Roche Diagnostics Corp. · Jul 2000
ONTRAK TESTCUP 502, MODEL 3016641
K001417 · Roche Diagnostics Corp. · Jun 2000
ACCUSIGN AMP 300, BIOSIGN AMP 300, STATUS DS AMP 300, SYVA RAPID TEST D.A.U.
K001225 · Princeton BioMeditech Corp. · May 2000