Cleared Special

K011620 - EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY

K011620 is the FDA 510(k) clearance for EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY by Syva Co., Dade Behring, Inc.. It is a Class 2 Toxicology device (product code LAN) cleared through the Special 510(k) pathway after a 24-day FDA review.

K011620 · Syva Co., Dade Behring, Inc. · Toxicology device
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Jun 2001
Decision
24d
Days
Class 2
Risk

K011620 is an FDA 510(k) clearance for the EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229. Classified as Enzyme Immunoassay, N-acetylprocainamide (product code LAN), Class II - Special Controls.

Submitted by Syva Co., Dade Behring, Inc. (San Jose, US). The FDA issued a Cleared decision on June 18, 2001 after a review of 24 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Syva Co., Dade Behring, Inc. devices

Submission Details

510(k) Number K011620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2001
Decision Date June 18, 2001
Days to Decision 24 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 87d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

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 19
Devices cleared under the same product code (LAN) and FDA review panel - the closest regulatory comparables to K011620.
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
N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
K971713 · Bayer Corp. · Jun 1997
AXSYM N-ACETYLPROCAINAMIDE
K955422 · Abbott Laboratories · Apr 1996
OPUS NAPA
K934705 · Pb Diagnostic Systems, Inc. · Nov 1993