Cleared Traditional

K864751 - TDXR CANNABINOIDS

K864751 is an FDA 510(k) clearance for TDXR CANNABINOIDS, manufactured by Abbott Laboratories. The device is a Class 2 Chemistry device with product code LDJ cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K864751 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1987
Decision
98d
Days
Class 2
Risk

K864751 is an FDA 510(k) clearance for the TDXR 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 March 13, 1987 after a review of 98 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott Laboratories devices

FDA 510(k) Submission Details - K864751

510(k) Number K864751 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1986
Decision Date March 13, 1987
Days to Decision 98 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
10d slower than avg
Panel avg: 88d · This submission: 98d
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 Chemistry 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 K864751.
LABELING CHANGE CANNABINOIDS DOUBLE ANTI. IN URINE
K873753 · Diagnostic Products Corp. · Oct 1987
DOUBLE ANTIBODY CANNABINOIDS KTHD1 AND KTHD5
K871695 · Diagnostic Products Corp. · Jun 1987
ABUSCREEN (R) EIA CANNABINOIDS
K870377 · Roche Diagnostic Systems, Inc. · Mar 1987
EMIT D.A.U. CANNABINOID 20NG ASSAY
K860500 · Syva Co. · Apr 1986
EMIT 700 CANNABINOID 20 ASSAY
K851373 · Syva Co. · May 1985
EMIT 700 CANNABINOID ASSAY
K843421 · Syva Co. · Sep 1984