Cleared Traditional

K881814 - ABUSCREEN(R) ONTRAK(TM) FOR THC

K881814 is an FDA 510(k) clearance for ABUSCREEN ONTRAK(TM) FOR THC, manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 2 Toxicology device with 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

FDA 510(k) Submission Details - K881814

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.

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 120
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