Cleared Traditional

K890693 - ADX CANNABINOIDS

K890693 is an FDA 510(k) clearance for ADX CANNABINOIDS, manufactured by Abbott Laboratories. The device is a Class 2 Toxicology device with product code LDJ cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K890693 · Abbott Laboratories · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1989
Decision
196d
Days
Class 2
Risk

K890693 is an FDA 510(k) clearance for the ADX 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 August 25, 1989 after a review of 196 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott Laboratories devices

FDA 510(k) Submission Details - K890693

510(k) Number K890693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1989
Decision Date August 25, 1989
Days to Decision 196 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
109d slower than avg
Panel avg: 87d · This submission: 196d
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 94
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K890693.
MICROZYME THC ENZYME IMMUNOASSAY TEST KIT
K904635 · Immunotech Corp. · Nov 1990
MILENIA(TM) CANNABINOIDS
K901568 · Diagnostic Products Corp. · May 1990
HYCOR ACCUPINCH THC TEST
K901334 · Hycor Biomedical, Inc. · May 1990
ABUSCREEN FP FOR CANNABINOIDS
K890887 · Roche Diagnostic Systems, Inc. · Mar 1989
TDX CANNABINOIDS-GS
K883731 · Abbott Laboratories · Oct 1988
EMIT D.A.U. CANNABINOID 50 NG ASSAY & CALIBRATORS
K882313 · Syva Co. · Aug 1988