Cleared Traditional

K945194 - ABUSCREEN ONLINE CONTROLS

K945194 is an FDA 510(k) clearance for ABUSCREEN ONLINE CONTROLS, manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 1 Toxicology device with product code DIF cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K945194 · Roche Diagnostic Systems, Inc. · Toxicology device
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Dec 1994
Decision
46d
Days
Class 1
Risk

K945194 is an FDA 510(k) clearance for the ABUSCREEN ONLINE CONTROLS. 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 December 9, 1994 after a review of 46 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

FDA 510(k) Submission Details - K945194

510(k) Number K945194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1994
Decision Date December 09, 1994
Days to Decision 46 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
41d faster than avg
Panel avg: 87d · This submission: 46d
Pathway characteristics
Predicate-based equivalence.

DIF Device Classification - Class 1, General Controls

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 174
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K945194.
MULTI-DRUG CONTROL SET
K951135 · Microgenics Corp. · Apr 1995
DRUGS OF ABUSE CONTROLS
K950138 · E.I. Dupont DE Nemours & Co., Inc. · Feb 1995
ABUSCREEN ONTRAK POSITIVE CONTROL
K943999 · Roche Diagnostic Systems, Inc. · Jan 1995
THERAPEUTIC DRUG MONITORING CONTROL, ASSAYED
K942551 · Medi-Tech, Inc. · Oct 1994
DOA-PLUS, DRUGS OF ABUSE CONTROLS
K942257 · Medical Diagnostic Technologies, Inc. · Sep 1994
THERAPEUTIC DRUG MONITORING CONTROL, UNASSAYED
K942552 · Medi-Tech, Inc. · Sep 1994