Cleared Traditional

AXSYM OPIATES (K951287) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K951287 · Abbott Laboratories · Toxicology device
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Optimized for regulatory review, auditing and printing
May 1995
Decision
58d
Days
Class 2
Risk

K951287 is an FDA 510(k) clearance for the AXSYM OPIATES. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 18, 1995 after a review of 58 days - a notably fast clearance 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: 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 Abbott Laboratories devices

Submission Details

510(k) Number K951287 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1995
Decision Date May 18, 1995
Days to Decision 58 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
29d faster than avg
Panel avg: 87d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 88
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K951287.
IMMULITE OPIATES SCREEN/CONTROL MODULE
K962323 · Diagnostic Products Corp. · Mar 1997
CEDIA DAU OPIATE 2K ASSAY
K962795 · Boehringer Mannheim Corp. · Oct 1996
FRONTLINE OPIATES
K954498 · Boehringer Mannheim Corp. · Mar 1996
URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE
K950136 · E.I. Dupont DE Nemours & Co., Inc. · Apr 1995
EMIT(R) IIC OPIATE ASSAY
K935117 · Syva Co. · Jan 1994
IL TEST(TM) OPIATE
K913742 · Instrumentation Laboratory CO · Nov 1991