Cleared Traditional

K932549 - ABUSCREEN ONLINE LOW-CUTOFF CONTROLS

K932549 is an FDA 510(k) clearance for ABUSCREEN ONLINE LOW-CUTOFF 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 92-day FDA review.

K932549 · Roche Diagnostic Systems, Inc. · Toxicology device
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Aug 1993
Decision
92d
Days
Class 1
Risk

K932549 is an FDA 510(k) clearance for the ABUSCREEN ONLINE LOW-CUTOFF 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 August 26, 1993 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 862.3280 - 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

FDA 510(k) Submission Details - K932549

510(k) Number K932549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1993
Decision Date August 26, 1993
Days to Decision 92 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
5d slower than avg
Panel avg: 87d · This submission: 92d
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 K932549.
DRUGS OF ABUSE CONTROLS
K935285 · Medical Diagnostic Technologies, Inc. · Mar 1994
EMIT IIC NEGATIVE CONTROL, CONTROL I AND II
K935230 · Syva Co. · Jan 1994
BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLS
K934062 · Biotrack, Inc. · Dec 1993
ABUSCREEN ONLINE CONTROL
K931125 · 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