Cleared Traditional

K962323 - IMMULITE OPIATES SCREEN/CONTROL MODULE

K962323 is an FDA 510(k) clearance for IMMULITE OPIATES SCREEN/CONTROL MODULE, manufactured by Diagnostic Products Corp.. The device is a Class 2 Toxicology device with product code DJG cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K962323 · Diagnostic Products Corp. · Toxicology device
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Mar 1997
Decision
266d
Days
Class 2
Risk

K962323 is an FDA 510(k) clearance for the IMMULITE OPIATES SCREEN/CONTROL MODULE. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on March 10, 1997 after a review of 266 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 Diagnostic Products Corp. devices

FDA 510(k) Submission Details - K962323

510(k) Number K962323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1996
Decision Date March 10, 1997
Days to Decision 266 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
179d slower than avg
Panel avg: 87d · This submission: 266d
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 177
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K962323.
QUIKPAC II ONE STEP OPIATE TEST
K972405 · Drial Consultants, Inc. · Aug 1997
EMIT II OPIATES 300/2000 ASSAY
K971596 · Behring Diagnostics, Inc. · Jun 1997
AQ OPIATES (MORPHINE) TEST
K971361 · Bionike Laboratories, Inc. · Jun 1997
CEDIA DAU OPIATE 2K ASSAY
K962795 · Boehringer Mannheim Corp. · Oct 1996
FRONTLINE OPIATES
K954498 · Boehringer Mannheim Corp. · Mar 1996
OPIATES MICRO-PLATE ASSAY
K935565 · Solarcare Technologies Corp,Inc. · Jul 1995