Cleared Traditional

K912757 - ABUSCREEN RADIOIMMUNOASSAY FOR CANNABINIODS

K912757 is an FDA 510(k) clearance for ABUSCREEN RADIOIMMUNOASSAY FOR CANNABINIODS, 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 35-day FDA review.

K912757 · Roche Diagnostic Systems, Inc. · Toxicology device
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Jul 1991
Decision
35d
Days
Class 2
Risk

K912757 is an FDA 510(k) clearance for the ABUSCREEN RADIOIMMUNOASSAY FOR CANNABINIODS. 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 July 26, 1991 after a review of 35 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

FDA 510(k) Submission Details - K912757

510(k) Number K912757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1991
Decision Date July 26, 1991
Days to Decision 35 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 87d · This submission: 35d
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 K912757.
MICROPLATE CANNABINOIDS ASSAY
K924815 · Solarcare Technologies Corp,Inc. · Jan 1993
CANNABINOID EIA TEST
K920311 · Diagnostic Reagents, Inc. · Feb 1992
IL TEST CANNABINOID, 35282
K920418 · Instrumentation Laboratory CO · Feb 1992
ABUSCREEN FP FOR CANNABINOIDS (15-50)
K910592 · Roche Diagnostic Systems, Inc. · Jun 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