Cleared Traditional

K881816 - ABUSCREEN(R) ONTRAK(TM) FOR BARBITURATES

K881816 is an FDA 510(k) clearance for ABUSCREEN ONTRAK(TM) FOR BARBITURATES, manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 2 Toxicology device with product code DKN cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K881816 · Roche Diagnostic Systems, Inc. · Toxicology device
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Jul 1988
Decision
91d
Days
Class 2
Risk

K881816 is an FDA 510(k) clearance for the ABUSCREEN(R) ONTRAK(TM) FOR BARBITURATES. Classified as Radioimmunoassay, Barbiturate (product code DKN), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on July 28, 1988 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3150 - 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 - K881816

510(k) Number K881816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1988
Decision Date July 28, 1988
Days to Decision 91 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
4d slower than avg
Panel avg: 87d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DKN Device Classification - Class 2, Special Controls

Product Code DKN Radioimmunoassay, Barbiturate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3150
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.