Cleared Traditional

K910589 - ABUSCREEN FP FOR CANNABINOIDS (50-100)

K910589 is the FDA 510(k) clearance for ABUSCREEN FP FOR CANNABINOIDS (50-100) by Roche Diagnostic Systems, Inc.. It is a Class 2 Toxicology device (product code LDJ) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K910589 · Roche Diagnostic Systems, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1991
Decision
50d
Days
Class 2
Risk

K910589 is an FDA 510(k) clearance for the ABUSCREEN FP FOR CANNABINOIDS (50-100). 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 April 3, 1991 after a review of 50 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K910589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1991
Decision Date April 03, 1991
Days to Decision 50 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
37d faster than avg
Panel avg: 87d · This submission: 50d
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 K910589.
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 (15-50)
K910592 · Roche Diagnostic Systems, Inc. · Jun 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
EMIT(R) II CANNABINOID 50 NG ASSAY
K904571 · Syva Co. · Dec 1990