Cleared Traditional

K963916 - IMMULITE CANNABINOIDS

K963916 is an FDA 510(k) clearance for IMMULITE CANNABINOIDS, manufactured by Diagnostic Products Corp.. The device is a Class 2 Toxicology device with product code LDJ cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K963916 · Diagnostic Products Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
210d
Days
Class 2
Risk

K963916 is an FDA 510(k) clearance for the IMMULITE CANNABINOIDS. Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on April 28, 1997 after a review of 210 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 Diagnostic Products Corp. devices

FDA 510(k) Submission Details - K963916

510(k) Number K963916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1996
Decision Date April 28, 1997
Days to Decision 210 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
123d slower than avg
Panel avg: 87d · This submission: 210d
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 119
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K963916.
QUICKSCREEN ONE STEP THC SCREENING TEST
K973122 · Phamatech · Sep 1997
ONE STEP MARIJUANA CARD TEST
K970548 · Teco Diagnostics · Jul 1997
BIONIKE AQ ONE STEP CANNABINOIDS (THC) TEST
K971841 · Bionike Laboratories, Inc. · Jun 1997
QUIKSTRIP ONESTEP MARIJUANA (THC) TEST
K963654 · Syntron Bioresearch, Inc. · Feb 1997
QUICKPAC II ONE STEP MARIJUANA (THC) TEST
K963207 · Drial Consultants, Inc. · Feb 1997
VERDICT THC
K963516 · Editek, Inc. · Oct 1996