Cleared Traditional

K943998 - CANNABINOID EIA ASSAY

K943998 is the FDA 510(k) clearance for CANNABINOID EIA ASSAY by Diagnostic Reagents, Inc.. It is a Class 2 Toxicology device (product code LDJ) cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K943998 · Diagnostic Reagents, Inc. · Toxicology device
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Nov 1994
Decision
136d
Days
Class 2
Risk

K943998 is an FDA 510(k) clearance for the CANNABINOID EIA ASSAY. Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Diagnostic Reagents, Inc. (Mountain View, US). The FDA issued a Cleared decision on November 4, 1994 after a review of 136 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.

View all Diagnostic Reagents, Inc. devices

Submission Details

510(k) Number K943998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1994
Decision Date November 04, 1994
Days to Decision 136 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 87d · This submission: 136d
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 K943998.
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K944562 · Microgenics Corp. · Nov 1994
CEDIA DAU MULTI-LEVEL THC ASSAY
K942337 · Microgenics Corp. · Aug 1994
CEDIA DAU MULTI-LEVEL THC ASSAY, HITACHI 911 REAGENT/ AND THE HITACHI 747 REAGENT
K940649 · Microgenics Corp. · May 1994