Cleared Traditional

K971713 - N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYE...

K971713 is the FDA 510(k) clearance for N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYE... by Bayer Corp.. It is a Class 2 Toxicology device (product code LAN) cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K971713 · Bayer Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
33d
Days
Class 2
Risk

K971713 is an FDA 510(k) clearance for the N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM. Classified as Enzyme Immunoassay, N-acetylprocainamide (product code LAN), Class II - Special Controls.

Submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on June 11, 1997 after a review of 33 days - a notably fast clearance cycle.

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: 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 Bayer Corp. devices

Submission Details

510(k) Number K971713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1997
Decision Date June 11, 1997
Days to Decision 33 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
54d faster than avg
Panel avg: 87d · This submission: 33d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K971713.
TDM N-ACETYLPROCAINAMIDE
K060738 · Roche Diagnostics Corp. · Aug 2006
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
AXSYM N-ACETYLPROCAINAMIDE
K955422 · Abbott Laboratories · Apr 1996
OPUS NAPA
K934705 · Pb Diagnostic Systems, Inc. · Nov 1993
EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY AND CALIBRAT
K922915 · Syva Co. · Aug 1992