Cleared Traditional

K954498 - FRONTLINE OPIATES

K954498 is an FDA 510(k) clearance for FRONTLINE OPIATES, manufactured by Boehringer Mannheim Corp.. The device is a Class 2 Toxicology device with product code DJG cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K954498 · Boehringer Mannheim Corp. · Toxicology device
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Optimized for regulatory review, auditing and printing
Mar 1996
Decision
161d
Days
Class 2
Risk

K954498 is an FDA 510(k) clearance for the FRONTLINE OPIATES. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Rockville, US). The FDA issued a Cleared decision on March 6, 1996 after a review of 161 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3650 - 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 Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K954498

510(k) Number K954498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1995
Decision Date March 06, 1996
Days to Decision 161 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
74d slower than avg
Panel avg: 87d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DJG Device Classification - Class 2, Special Controls

Product Code DJG Enzyme Immunoassay, Opiates
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3650
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.

Regulatory Peers - DJG Enzyme Immunoassay, Opiates

All 147
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K954498.
EMIT II OPIATES 300/2000 ASSAY
K971596 · Behring Diagnostics, Inc. · Jun 1997
IMMULITE OPIATES SCREEN/CONTROL MODULE
K962323 · Diagnostic Products Corp. · Mar 1997
CEDIA DAU OPIATE 2K ASSAY
K962795 · Boehringer Mannheim Corp. · Oct 1996
OPIATES MICRO-PLATE ASSAY
K935565 · Solarcare Technologies Corp,Inc. · Jul 1995
AXSYM OPIATES
K951287 · Abbott Laboratories · May 1995
URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE
K950136 · E.I. Dupont DE Nemours & Co., Inc. · Apr 1995