Cleared Traditional

K872882 - CANNABINOID ENZYME IMMUNOASSAY KIT

K872882 is the FDA 510(k) clearance for CANNABINOID ENZYME IMMUNOASSAY KIT by General Diagnostics. It is a Class 2 Toxicology device (product code LDJ) cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K872882 · General Diagnostics · Toxicology device
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Nov 1987
Decision
104d
Days
Class 2
Risk

K872882 is an FDA 510(k) clearance for the CANNABINOID ENZYME IMMUNOASSAY KIT. Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by General Diagnostics (Great Neck, US). The FDA issued a Cleared decision on November 3, 1987 after a review of 104 days - within the typical 510(k) review window.

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.

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Submission Details

510(k) Number K872882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1987
Decision Date November 03, 1987
Days to Decision 104 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
17d slower than avg
Panel avg: 87d · This submission: 104d
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 85
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K872882.
TDXR DELTA-9-CANNABINOIDS
K874646 · Abbott Laboratories · Dec 1987
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
STICKER LABEL FOR DRUGS OF ABUSE ASSAYS
K874156 · Syva Co. · Oct 1987
LABELING CHANGE CANNABINOIDS DOUBLE ANTI. IN URINE
K873753 · Diagnostic Products Corp. · Oct 1987