Cleared Traditional

LABELING SUBMITTAL, ADX TM CANNABINOIDS-GS (K904541) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K904541 · Abbott Laboratories · Toxicology device
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Nov 1990
Decision
47d
Days
Class 2
Risk

K904541 is an FDA 510(k) clearance for the LABELING SUBMITTAL, ADX TM CANNABINOIDS-GS. Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on November 20, 1990 after a review of 47 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 Abbott Laboratories devices

Submission Details

510(k) Number K904541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1990
Decision Date November 20, 1990
Days to Decision 47 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
40d faster than avg
Panel avg: 87d · This submission: 47d
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 57
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K904541.
EMIT(R) II CANNABINOID 20 NG ASSAY
K904570 · Syva Co. · Dec 1990
EMIT(R) II CANNABINOID 50 NG ASSAY
K904571 · Syva Co. · Dec 1990
ABUSCREEN ONTRAK FOR THC
K904856 · Roche Diagnostic Systems, Inc. · Dec 1990
MILENIA(TM) CANNABINOIDS
K901568 · Diagnostic Products Corp. · May 1990
ADX CANNABINOIDS
K890693 · Abbott Laboratories · Aug 1989
ABUSCREEN FP FOR CANNABINOIDS
K890887 · Roche Diagnostic Systems, Inc. · Mar 1989