Cleared Traditional

K954291 - OPUS TDM CONTROLS

K954291 is the FDA 510(k) clearance for OPUS TDM CONTROLS by Behring Diagnostics, Inc.. It is a Class 1 Toxicology device (product code DIF) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K954291 · Behring Diagnostics, Inc. · Toxicology device
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Nov 1995
Decision
67d
Days
Class 1
Risk

K954291 is an FDA 510(k) clearance for the OPUS TDM CONTROLS. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Behring Diagnostics, Inc. (Westwood, US). The FDA issued a Cleared decision on November 20, 1995 after a review of 67 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 Behring Diagnostics, Inc. devices

Submission Details

510(k) Number K954291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1995
Decision Date November 20, 1995
Days to Decision 67 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 87d · This submission: 67d
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 146
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K954291.
LYPHOCHEK BENZO/TCA CONTROL-SET B
K955153 · Bio-Rad · Feb 1996
DOCUMENT TDM ULTRA UNASSAYED CONTROL
K955155 · Casco Standards · Dec 1995
ONTRAJ TESTCUP COLLECTION/URINALYSIS PANEL
K954799 · Roche Diagnostic Systems, Inc. · Dec 1995
TRI-POINT LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL
K954322 · Medical Analysis Systems, Inc. · Oct 1995
ABUSCREEN ONLINE CONTROLS
K953739 · Roche Diagnostic Systems, Inc. · Sep 1995
ABUSCREEN ONLINE DRUG FREE URINE
K953845 · Roche Diagnostic Systems, Inc. · Sep 1995