Cleared Traditional

K874269 - REVISED LABELING FOR CANNABINOIDS TEST KIT

K874269 is the FDA 510(k) clearance for REVISED LABELING FOR CANNABINOIDS TEST KIT by Roche Diagnostic Systems, Inc.. It is a Class 2 Toxicology device (product code LDJ) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K874269 · Roche Diagnostic Systems, Inc. · Toxicology device
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Nov 1987
Decision
31d
Days
Class 2
Risk

K874269 is an FDA 510(k) clearance for the REVISED LABELING FOR CANNABINOIDS TEST KIT. Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Nutley, US). The FDA issued a Cleared decision on November 20, 1987 after a review of 31 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K874269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1987
Decision Date November 20, 1987
Days to Decision 31 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
56d faster than avg
Panel avg: 87d · This submission: 31d
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 83
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K874269.
ACA DU PONT URINE CANNABINOIDS (U THC) SCREEN METH
K875252 · E.I. Dupont DE Nemours & Co., Inc. · Feb 1988
TDXR DELTA-9-CANNABINOIDS
K874646 · Abbott Laboratories · Dec 1987
REVISED LABELING FOR TDX CANNABINOIDS
K874488 · Abbott Laboratories · 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