Cleared Traditional

K974840 - ABUSCREEN ONLINE II FOR OPIATES 300/2000

K974840 is the FDA 510(k) clearance for ABUSCREEN ONLINE II FOR OPIATES 300/2000 by Roche Diagnostic Systems, Inc.. It is a Class 2 Toxicology device (product code DJG) cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K974840 · Roche Diagnostic Systems, Inc. · Toxicology device
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Optimized for regulatory review, auditing and printing
Apr 1998
Decision
121d
Days
Class 2
Risk

K974840 is an FDA 510(k) clearance for the ABUSCREEN ONLINE II FOR OPIATES 300/2000, ABUSCREEN ONLINE OPIATES CALIBRATIO.... Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Somerville, US). The FDA issued a Cleared decision on April 24, 1998 after a review of 121 days - within the typical 510(k) review window.

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: 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.

View all Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K974840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1997
Decision Date April 24, 1998
Days to Decision 121 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 87d · This submission: 121d
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 135
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K974840.
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
ACCUSIGN MOP, BIOSIGN MOP, STAUS DS MOP
K981771 · Princeton BioMeditech Corp. · Jun 1998
QUICKSCREEN ONE STEP OPIATE SCREENING TEST (9080)
K972619 · Phamatech · Aug 1997
EMIT II OPIATES 300/2000 ASSAY
K971596 · Behring Diagnostics, Inc. · Jun 1997
IMMULITE OPIATES SCREEN/CONTROL MODULE
K962323 · Diagnostic Products Corp. · Mar 1997