Cleared Traditional

K962795 - CEDIA DAU OPIATE 2K ASSAY

K962795 is an FDA 510(k) clearance for CEDIA DAU OPIATE 2K ASSAY, 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 104-day FDA review.

K962795 · Boehringer Mannheim Corp. · Toxicology device
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Oct 1996
Decision
104d
Days
Class 2
Risk

K962795 is an FDA 510(k) clearance for the CEDIA DAU OPIATE 2K ASSAY. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Concord, US). The FDA issued a Cleared decision on October 30, 1996 after a review of 104 days - within the typical 510(k) review window.

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 - K962795

510(k) Number K962795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1996
Decision Date October 30, 1996
Days to Decision 104 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
17d slower than avg
Panel avg: 87d · This submission: 104d
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 K962795.
QUICKSCREEN ONE STEP OPIATE SCREENING TEST (9080)
K972619 · Phamatech · Aug 1997
EMIT II OPIATES 300/2000 ASSAY
K971596 · Behring Diagnostics, Inc. · Jun 1997
IMMULITE OPIATES SCREEN/CONTROL MODULE
K962323 · Diagnostic Products Corp. · Mar 1997
FRONTLINE OPIATES
K954498 · Boehringer Mannheim Corp. · Mar 1996
OPIATES MICRO-PLATE ASSAY
K935565 · Solarcare Technologies Corp,Inc. · Jul 1995
AXSYM OPIATES
K951287 · Abbott Laboratories · May 1995