Cleared Traditional

K992890 - ROCHE COBAS INTEGRA OPIATES 300/2000

K992890 is the FDA 510(k) clearance for ROCHE COBAS INTEGRA OPIATES 300/2000 by Roche Diagnostics Corp.. It is a Class 2 Toxicology device (product code DJG) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K992890 · Roche Diagnostics Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
88d
Days
Class 2
Risk

K992890 is an FDA 510(k) clearance for the ROCHE COBAS INTEGRA OPIATES 300/2000. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on November 23, 1999 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3650 - 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 K992890 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1999
Decision Date November 23, 1999
Days to Decision 88 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
1d slower than avg
Panel avg: 87d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DJG Enzyme Immunoassay, Opiates
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3650
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 - DJG Enzyme Immunoassay, Opiates

All 107
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K992890.
URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A
K003209 · Dade Behring, Inc. · Dec 2000
CEDIA DAU 6-ACETYLMORPHINE ASSAY
K001178 · Microgenics Corp. · Jun 2000
URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 90A
K000464 · Dade Behring, Inc. · Apr 2000
ACCUSIGN DOA3,DOA, COC/THC/OPI2000 DOA3
K992422 · Princeton BioMeditech Corp. · Aug 1999
SYNCHRON SYSTEMS OPIATES 2000 NG (OP2) REAGENT
K984152 · Beckman Coulter, Inc. · Jan 1999
MODIFICATION OF EMIT D.A.U. OPIATES ASSAY
K984232 · Syva Co. · Jan 1999