Cleared Traditional

K910592 - ABUSCREEN FP FOR CANNABINOIDS (15-50)

K910592 is the FDA 510(k) clearance for ABUSCREEN FP FOR CANNABINOIDS (15-50) by Roche Diagnostic Systems, Inc.. It is a Class 2 Toxicology device (product code LDJ) cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K910592 · Roche Diagnostic Systems, Inc. · Toxicology device
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Jun 1991
Decision
129d
Days
Class 2
Risk

K910592 is an FDA 510(k) clearance for the ABUSCREEN FP FOR CANNABINOIDS (15-50). Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on June 21, 1991 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3870 - 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 K910592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1991
Decision Date June 21, 1991
Days to Decision 129 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 87d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LDJ Enzyme Immunoassay, Cannabinoids
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3870
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 - LDJ Enzyme Immunoassay, Cannabinoids

All 83
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K910592.
CANNABINOID EIA TEST
K920311 · Diagnostic Reagents, Inc. · Feb 1992
IL TEST CANNABINOID, 35282
K920418 · Instrumentation Laboratory CO · Feb 1992
ABUSCREEN RADIOIMMUNOASSAY FOR CANNABINIODS
K912757 · Roche Diagnostic Systems, Inc. · Jul 1991
ABUSCREEN FP FOR CANNABINOIDS (50-100)
K910589 · Roche Diagnostic Systems, Inc. · Apr 1991
EMIT(R) II CANNABINOID 100 NG ASSAY
K904568 · Syva Co. · Dec 1990
EMIT(R) II CANNABINOID 20 NG ASSAY
K904570 · Syva Co. · Dec 1990