Cleared Traditional

K951853 - ONE STEP URINE DRUG OF ABUSE CANNABINOI...

K951853 is the FDA 510(k) clearance for ONE STEP URINE DRUG OF ABUSE CANNABINOI... by Tcpi, Inc.. It is a Class 2 Toxicology device (product code LDJ) cleared through the Traditional 510(k) pathway after a 487-day FDA review.

K951853 · Tcpi, Inc. · Toxicology device
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Optimized for regulatory review, auditing and printing
Aug 1996
Decision
487d
Days
Class 2
Risk

K951853 is an FDA 510(k) clearance for the ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC). Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Tcpi, Inc. (Pompano Beach, US). The FDA issued a Cleared decision on August 20, 1996 after a review of 487 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Toxicology submissions.

View all Tcpi, Inc. devices

Submission Details

510(k) Number K951853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1995
Decision Date August 20, 1996
Days to Decision 487 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
400d slower than avg
Panel avg: 87d · This submission: 487d
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 86
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K951853.
QUICKSCREEN ONE STEP THC SCREENING TEST
K973122 · Phamatech · Sep 1997
ONE STEP MARIJUANA CARD TEST
K970548 · Teco Diagnostics · Jul 1997
IMMULITE CANNABINOIDS
K963916 · Diagnostic Products Corp. · Apr 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