Cleared Traditional

TDXR DELTA-9-CANNABINOIDS (K874646) - FDA 510(k) Clearance

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

K874646 · Abbott Laboratories · Chemistry device
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Dec 1987
Decision
35d
Days
Class 2
Risk

K874646 is an FDA 510(k) clearance for the TDXR DELTA-9-CANNABINOIDS. 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 December 18, 1987 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3870 - the FDA in vitro diagnostics and chemistry 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 K874646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1987
Decision Date December 18, 1987
Days to Decision 35 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 88d · This submission: 35d
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 Chemistry 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 K874646.
ABUSCREEN(R) ONTRAK(TM) FOR THC
K881814 · Roche Diagnostic Systems, Inc. · Jul 1988
REVISED LABELING FOR ADX CANNABINOIDS
K880015 · Abbott Laboratories · Mar 1988
ACA DU PONT URINE CANNABINOIDS (U THC) SCREEN METH
K875252 · E.I. Dupont DE Nemours & Co., Inc. · Feb 1988
REVISED LABELING FOR TDX CANNABINOIDS
K874488 · Abbott Laboratories · Nov 1987
REVISED LABELING FOR CANNABINOIDS TEST KIT
K874269 · Roche Diagnostic Systems, Inc. · Nov 1987
REVISED LABELING FOR SYVA CANNABINOID ASSAYS
K874079 · Syva Co. · Oct 1987