Cleared Traditional

K893856 - ABUSCREEN ONTRAK POS. REF. CONTROL FOR ...

K893856 is the FDA 510(k) clearance for ABUSCREEN ONTRAK POS. REF. CONTROL FOR ... by Roche Diagnostic Systems, Inc.. It is a Class 1 Toxicology device (product code LAS) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K893856 · Roche Diagnostic Systems, Inc. · Toxicology device
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Aug 1989
Decision
70d
Days
Class 1
Risk

K893856 is an FDA 510(k) clearance for the ABUSCREEN ONTRAK POS. REF. CONTROL FOR MORPHINE. Classified as Drug Specific Control Materials (product code LAS), Class I - General Controls.

Submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on August 3, 1989 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3280 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K893856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1989
Decision Date August 03, 1989
Days to Decision 70 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
17d faster than avg
Panel avg: 87d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LAS Drug Specific Control Materials
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3280
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LAS Drug Specific Control Materials

All 53
Devices cleared under the same product code (LAS) and FDA review panel - the closest regulatory comparables to K893856.
ABUSCREEN POSITIVE REFERENCE CONTROLS
K894464 · Roche Diagnostic Systems, Inc. · Aug 1989
ABUSCREEN TRI-LEVEL REFERENCE CONTROLS
K894463 · Roche Diagnostic Systems, Inc. · Aug 1989
ABUSCREEN ONTRAK POS. REF. CONTROL FOR BARBITUATES
K893855 · Roche Diagnostic Systems, Inc. · Aug 1989
ABUSCREEN ONTRAK POS. REF. CONTROL FOR AMPHETAMINE
K893857 · Roche Diagnostic Systems, Inc. · Aug 1989
ABUSCREEN ONTRAK POS. REFERENCE CONTROL FOR THC
K893858 · Roche Diagnostic Systems, Inc. · Aug 1989
ABUSCREEN ONTRAK POS. REF. CONTROL FOR COCAINE
K893859 · Roche Diagnostic Systems, Inc. · Aug 1989