Cleared Traditional

K952096 - ONE STEP URINE DRUG OF ABUSE OPIATE TES...

K952096 is the FDA 510(k) clearance for ONE STEP URINE DRUG OF ABUSE OPIATE TES... by Tcpi, Inc.. It is a Class 2 Toxicology device (product code DJG) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K952096 · Tcpi, Inc. · Toxicology device
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Aug 1995
Decision
105d
Days
Class 2
Risk

K952096 is an FDA 510(k) clearance for the ONE STEP URINE DRUG OF ABUSE OPIATE TEST (OPIUM/HEROIN/MORPHINE). Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Tcpi, Inc. (Pompano Beach, US). The FDA issued a Cleared decision on August 17, 1995 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3650 - 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 Tcpi, Inc. devices

Submission Details

510(k) Number K952096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1995
Decision Date August 17, 1995
Days to Decision 105 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
18d slower than avg
Panel avg: 87d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DJG Enzyme Immunoassay, Opiates
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3650
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 - DJG Enzyme Immunoassay, Opiates

All 137
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K952096.
IMMULITE OPIATES SCREEN/CONTROL MODULE
K962323 · Diagnostic Products Corp. · Mar 1997
CEDIA DAU OPIATE 2K ASSAY
K962795 · Boehringer Mannheim Corp. · Oct 1996
FRONTLINE OPIATES
K954498 · Boehringer Mannheim Corp. · Mar 1996
AXSYM OPIATES
K951287 · Abbott Laboratories · May 1995
URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE
K950136 · E.I. Dupont DE Nemours & Co., Inc. · Apr 1995
ABUSIGN(TM) OPI, DOA-OPI, ACCUSIGN(TM) OPI, DOA-OPI, BIOSIGN(TM) OPI, DOA-OPI
K945608 · Princeton BioMeditech Corp. · Feb 1995