Cleared Traditional

K955422 - AXSYM N-ACETYLPROCAINAMIDE

K955422 is an FDA 510(k) clearance for AXSYM N-ACETYLPROCAINAMIDE, manufactured by Abbott Laboratories. The device is a Class 2 Toxicology device with product code LAN cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K955422 · Abbott Laboratories · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
148d
Days
Class 2
Risk

K955422 is an FDA 510(k) clearance for the AXSYM N-ACETYLPROCAINAMIDE. Classified as Enzyme Immunoassay, N-acetylprocainamide (product code LAN), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on April 24, 1996 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3320 - 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K955422

510(k) Number K955422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1995
Decision Date April 24, 1996
Days to Decision 148 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
61d slower than avg
Panel avg: 87d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LAN Device Classification - Class 2, Special Controls

Product Code LAN Enzyme Immunoassay, N-acetylprocainamide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3320
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 - LAN Enzyme Immunoassay, N-acetylprocainamide

All 18
Devices cleared under the same product code (LAN) and FDA review panel - the closest regulatory comparables to K955422.
DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111
K032564 · Dade Behring, Inc. · Oct 2003
NAPA EIA ASSAY
K983812 · Diagnostic Reagents, Inc. · Nov 1998
N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
K971713 · Bayer Corp. · Jun 1997
OPUS NAPA
K934705 · Pb Diagnostic Systems, Inc. · Nov 1993
EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY AND CALIBRAT
K922915 · Syva Co. · Aug 1992
EASY-TEST EMIT N-ACETYLPROCAINAMIDE NAPA #16649
K873349 · Em Diagnostic Systems, Inc. · Sep 1987