Cleared Traditional

K974840 - ABUSCREEN ONLINE II FOR OPIATES 300/2000, ABUSCREEN ONLINE OPIATES CALIBRATION PACK, ABUSCREEN ONLINE OPIATES CONTROL

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

K974840 · Roche Diagnostic Systems, Inc. · Toxicology device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K974840

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.

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 179
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K974840.
DBEST OPIATES TEST KIT
K983190 · Ameritek, Inc. · Nov 1998
ACCUSIGN MOP, BIOSIGN MOP, STAUS DS MOP
K981771 · Princeton BioMeditech Corp. · Jun 1998
STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION)
K981341 · OraSure Technologies, Inc. · May 1998
MICRO-STRIP FOR OPIATE METABOLITES
K973761 · Microdiagnostics, Inc. · Dec 1997
UBI MAGIWEL AMPHETAMINE METABOLITES
K973153 · United Biotech, Inc. · Oct 1997
UBI MAGIWEL OPIATE METABOLITES
K973155 · United Biotech, Inc. · Oct 1997