Cleared Traditional

K951853 - ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC)

K951853 is an FDA 510(k) clearance for ONE STEP URINE DRUG OF ABUSE CANNABINOI..., manufactured by Tcpi, Inc.. The device is a Class 2 Toxicology device with 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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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

FDA 510(k) Submission Details - K951853

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
Combination Product No
PCCP Authorized No
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.

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 124
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K951853.
QUICKPAC II ONE STEP MARIJUANA (THC) TEST
K963207 · Drial Consultants, Inc. · Feb 1997
VERDICT THC
K963516 · Editek, Inc. · Oct 1996
VISUALINE COMBO V (COCAINE/THC) TEST
K963606 · Sun Biomedical Laboratories, Inc. · Oct 1996
SYNCHRON SYSTEMS CANNABINOID 20 NG REAGENT
K955677 · Beckman Instruments, Inc. · Apr 1996
FRONTLINE CANNABIS
K954497 · Boehringer Mannheim Corp. · Mar 1996
VISUALINE II CANNABINOIDS (THC)
K950445 · Sun Biomedical Laboratories, Inc. · May 1995