Cleared Traditional

K992890 - ROCHE COBAS INTEGRA OPIATES 300/2000

K992890 is an FDA 510(k) clearance for ROCHE COBAS INTEGRA OPIATES 300/2000, manufactured by Roche Diagnostics Corp.. The device is a Class 2 Toxicology device with 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

FDA 510(k) Submission Details - K992890

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.

DJG Device Classification - Class 2, Special Controls

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 169
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K992890.
RADID DRUG SCREEN 5-PANEL TEST
K993151 · American Bio Medica Corp. · Jan 2000
AT HOME DRUG TEST, MODEL 9083
K994234 · Phamatech · Dec 1999
VERDICT -II OPIATES 2000
K992111 · Medtox Diagnostics, Inc. · Dec 1999
QUICKSTRIP ONE STEP OPIATES TEST
K993490 · Syntron Bioresearch, Inc. · Oct 1999
QUICKPAC II ONE STEP OPIATES TEST
K993491 · Syntron Bioresearch, Inc. · Oct 1999
QUICKSCREEN PRO MULTI DRUG SCREEN, MODEL 9177 & 9178
K993165 · Phamatech · Oct 1999