Cleared Traditional

K023296 - COBAS INTEGRA ONLINE DAT II COCAINE II

K023296 is the FDA 510(k) clearance for COBAS INTEGRA ONLINE DAT II COCAINE II by Roche Diagnostics Corp.. It is a Class 2 Toxicology device (product code DIO) cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K023296 · Roche Diagnostics Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2002
Decision
54d
Days
Class 2
Risk

K023296 is an FDA 510(k) clearance for the COBAS INTEGRA ONLINE DAT II COCAINE II. Classified as Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on November 25, 2002 after a review of 54 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. 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 K023296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2002
Decision Date November 25, 2002
Days to Decision 54 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
33d faster than avg
Panel avg: 87d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 64
Devices cleared under the same product code (DIO) and FDA review panel - the closest regulatory comparables to K023296.
RANDOX EVIDENCE
K030360 · Randox Laboratories, Ltd. · Dec 2003
EMIT II PLUS COCAINE METABOLITE ASSAY
K031512 · Dade Behring, Inc. · Jul 2003
ONLINE DAT II COCAINE II
K023281 · Roche Diagnostics Corp. · Dec 2002
LIFESIGN COCAINE, MARIJUANA (THC), LIFESIGN DOA2 (THC/COC), STATUS STIK THC/COC, ACCUSIGN STIK THC/COC, ACCUSTIK THC/COC
K014067 · Princeton BioMeditech Corp. · Jun 2002
LIFESIGN COC, STATUS STIK COC, ACCUSIGN STIK COC, ACCUSTIK COC
K014069 · Princeton BioMeditech Corp. · Jun 2002
ACON ONE STEP DRUG SCREEN TEST CARD
K020771 · ACON Laboratories, Inc. · May 2002