Cleared Traditional

K931125 - ABUSCREEN ONLINE CONTROL

K931125 is the FDA 510(k) clearance for ABUSCREEN ONLINE CONTROL by Roche Diagnostic Systems, Inc.. It is a Class 1 Toxicology device (product code DIF) cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K931125 · Roche Diagnostic Systems, Inc. · Toxicology device
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Aug 1993
Decision
152d
Days
Class 1
Risk

K931125 is an FDA 510(k) clearance for the ABUSCREEN ONLINE CONTROL. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on August 3, 1993 after a review of 152 days - an extended review 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: 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

Submission Details

510(k) Number K931125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1993
Decision Date August 03, 1993
Days to Decision 152 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 87d · This submission: 152d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DIF Drug Mixture 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 - DIF Drug Mixture Control Materials

All 131
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K931125.
DRUGS OF ABUSE CONTROLS
K935285 · Medical Diagnostic Technologies, Inc. · Mar 1994
EMIT IIC NEGATIVE CONTROL, CONTROL I AND II
K935230 · Syva Co. · Jan 1994
ABUSCREEN ONLINE LOW-CUTOFF CONTROLS
K932549 · Roche Diagnostic Systems, Inc. · Aug 1993
LYPHOCHEK(R) URINE TOXICOLOGY SCREEN-LOW CONTROL
K932643 · Bio-Rad · Jul 1993
COBAS-FP TDM CONTROLS
K930269 · Roche Diagnostic Systems, Inc. · Feb 1993
DRUG OF ABUSE URINE CONTROL
K920477 · Diagnostic Reagents, Inc. · Mar 1992