Cleared Traditional

K881817 - ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINES

K881817 is an FDA 510(k) clearance for ABUSCREEN ONTRAK(TM) FOR AMPHETAMINES, manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 2 Toxicology device with product code DJP cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K881817 · Roche Diagnostic Systems, Inc. · Toxicology device
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Jul 1988
Decision
92d
Days
Class 2
Risk

K881817 is an FDA 510(k) clearance for the ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINES. Classified as Radioimmunoassay, Amphetamine (product code DJP), 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 862.3100 - 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 - K881817

510(k) Number K881817 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.

DJP Device Classification - Class 2, Special Controls

Product Code DJP Radioimmunoassay, Amphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3100
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 - DJP Radioimmunoassay, Amphetamine

All 8
Devices cleared under the same product code (DJP) and FDA review panel - the closest regulatory comparables to K881817.
URINE AMPHETAMINE DIRECT RIA KIT (I-125)
K913866 · Immunalysis Corporation · Sep 1991
ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE
K912755 · Roche Diagnostic Systems, Inc. · Aug 1991
REVISED DOUBLE ANTIBODY AMPHETAMINE
K882228 · Diagnostic Products Corp. · Aug 1988
ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE-HIGH SP
K854009 · Roche Diagnostic Systems, Inc. · Oct 1985
ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE
K830482 · Hoffmann-La Roche, Inc. · Mar 1983
ABUSCREEN RADIOIMMUNOASSAY - AMPHETAMINE
K823212 · Hoffmann-La Roche, Inc. · Nov 1982