Cleared Traditional

K881815 - ABUSCREEN(R) ONTRAK(TM) FOR COCAINE

K881815 is an FDA 510(k) clearance for ABUSCREEN ONTRAK(TM) FOR COCAINE, manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 2 Toxicology device with product code DIO cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K881815 · Roche Diagnostic Systems, Inc. · Toxicology device
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Jul 1988
Decision
92d
Days
Class 2
Risk

K881815 is an FDA 510(k) clearance for the ABUSCREEN(R) ONTRAK(TM) FOR COCAINE. Classified as Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO), 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 862.3250 - 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 - K881815

510(k) Number K881815 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.

DIO Device Classification - Class 2, Special Controls

Product Code DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3250
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 - DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

All 111
Devices cleared under the same product code (DIO) and FDA review panel - the closest regulatory comparables to K881815.
ADX COCAINE METABOLITE
K890788 · Abbott Laboratories · Aug 1989
ABUSCREEN FP BUFFER REAGENT
K890883 · Roche Diagnostic Systems, Inc. · Mar 1989
ABUSCREEN FP FOR COCAINE METABOLITE
K890885 · Roche Diagnostic Systems, Inc. · Mar 1989
EMIT HVA COCAINE METABOLITE ASSAY
K881942 · Syva Co. · Jul 1988
REVISED LABELING FOR ADX COCAINE METABOLITE
K880009 · Abbott Laboratories · Mar 1988
REVISED LABELING FOR TDX COCAINE METABOLITE
K874487 · Abbott Laboratories · Nov 1987