Cleared Traditional

K910592 - ABUSCREEN FP FOR CANNABINOIDS (15-50)

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

K910592 · Roche Diagnostic Systems, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K910592

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.

LDJ Device Classification - Class 2, Special Controls

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 120
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
TARGET(TM) CANNABINOIDS-V TEST
K910892 · V-Tech, Inc. · Apr 1991
TARGET(TM) CANNABINOIDS-R TEST
K910893 · V-Tech, Inc. · Apr 1991