Cleared Traditional

TDX CANNABINOIDS-GS (K883731) - FDA 510(k) Clearance

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

K883731 · Abbott Laboratories · Toxicology device
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Oct 1988
Decision
41d
Days
Class 2
Risk

K883731 is an FDA 510(k) clearance for the TDX 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 October 11, 1988 after a review of 41 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 K883731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1988
Decision Date October 11, 1988
Days to Decision 41 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
46d faster than avg
Panel avg: 87d · This submission: 41d
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 K883731.
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
EMIT D.A.U. CANNABINOID 50 NG ASSAY & CALIBRATORS
K882313 · Syva Co. · Aug 1988
EMIT HVA CANNABINOID 100 NG ASSAY
K882819 · Syva Co. · Aug 1988
ABUSCREEN(R) ONTRAK(TM) FOR THC
K881814 · Roche Diagnostic Systems, Inc. · Jul 1988