Cleared Traditional

K905491 - MICROLINE SCREEN FOR OPIATES

K905491 is an FDA 510(k) clearance for MICROLINE SCREEN FOR OPIATES, manufactured by Drug Screening Systems, Inc.. The device is a Class 2 Toxicology device with product code DJG cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K905491 · Drug Screening Systems, Inc. · Toxicology device
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Mar 1991
Decision
96d
Days
Class 2
Risk

K905491 is an FDA 510(k) clearance for the MICROLINE SCREEN FOR OPIATES. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Drug Screening Systems, Inc. (Blackwood, US). The FDA issued a Cleared decision on March 13, 1991 after a review of 96 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 Drug Screening Systems, Inc. devices

FDA 510(k) Submission Details - K905491

510(k) Number K905491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1990
Decision Date March 13, 1991
Days to Decision 96 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 87d · This submission: 96d
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 194
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K905491.
OPIATE EIA ASSAY
K915180 · Diagnostic Reagents, Inc. · Jan 1992
IL TEST(TM) OPIATE
K913742 · Instrumentation Laboratory CO · Nov 1991
URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125)
K913863 · Immunalysis Corporation · Sep 1991
ABUSCREEN ONLINE TM FOR OPIATES
K904997 · Roche Diagnostic Systems, Inc. · Dec 1990
BIOSITE DIAGNOSTICS OPIATE SCREENING TEST
K902924 · Biosite Incorporated · Sep 1990
EMIT(R) II OPIATE ASSAY
K902577 · Syva Co. · Jul 1990