Cleared Traditional

K881814 - ABUSCREEN ONTRAK(TM) FOR THC

K881814 is the FDA 510(k) clearance for ABUSCREEN ONTRAK(TM) FOR THC by Roche Diagnostic Systems, Inc.. It is a Class 2 Toxicology device (product code LDJ) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K881814 · Roche Diagnostic Systems, Inc. · Toxicology device
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Jul 1988
Decision
92d
Days
Class 2
Risk

K881814 is an FDA 510(k) clearance for the ABUSCREEN(R) ONTRAK(TM) FOR THC. Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on July 29, 1988 after a review of 92 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 Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K881814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1988
Decision Date July 29, 1988
Days to Decision 92 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
5d slower than avg
Panel avg: 87d · This submission: 92d
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 K881814.
TDX CANNABINOIDS-GS
K883731 · Abbott Laboratories · Oct 1988
EMIT D.A.U. CANNABINOID 50 NG ASSAY & CALIBRATORS
K882313 · Syva Co. · Aug 1988
EMIT HVA CANNABINOID 100 NG ASSAY
K882819 · Syva Co. · Aug 1988
REVISED LABELING FOR ADX CANNABINOIDS
K880015 · Abbott Laboratories · Mar 1988
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