Cleared Traditional

K963916 - IMMULITE CANNABINOIDS

K963916 is the FDA 510(k) clearance for IMMULITE CANNABINOIDS by Diagnostic Products Corp.. It is a Class 2 Toxicology device (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

Submission Details

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.

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 80
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K963916.
ABUSCREEN ONLINE FOR CANNABINOIDS (1000 TEST KIT)
K981585 · Roche Diagnostic Systems, Inc. · May 1998
QUICKSCREEN ONE STEP THC SCREENING TEST
K973122 · Phamatech · Sep 1997
ONE STEP MARIJUANA CARD TEST
K970548 · Teco Diagnostics · Jul 1997
SYNCHRON SYSTEMS CANNABINOID 20 NG REAGENT
K955677 · Beckman Instruments, Inc. · Apr 1996
FRONTLINE CANNABIS
K954497 · Boehringer Mannheim Corp. · Mar 1996
URINE CANNABINOIDS SCREEN FLEX(TM) REAGENT CARTRIDGE
K950181 · E.I. Dupont DE Nemours & Co., Inc. · Apr 1995