Cleared Special

K010812 - EMIT 2000 PROCAINAMIDE ASSAY

K010812 is the FDA 510(k) clearance for EMIT 2000 PROCAINAMIDE ASSAY by Syva Co., Dade Behring, Inc.. It is a Class 2 Chemistry device (product code LAR) cleared through the Special 510(k) pathway after a 25-day FDA review.

K010812 · Syva Co., Dade Behring, Inc. · Chemistry device
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Apr 2001
Decision
25d
Days
Class 2
Risk

K010812 is an FDA 510(k) clearance for the EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229. Classified as Enzyme Immunoassay, Procainamide (product code LAR), Class II - Special Controls.

Submitted by Syva Co., Dade Behring, Inc. (San Jose, US). The FDA issued a Cleared decision on April 13, 2001 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3320 - the FDA in vitro diagnostics and chemistry 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 K010812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2001
Decision Date April 13, 2001
Days to Decision 25 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 88d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LAR Enzyme Immunoassay, Procainamide
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 Chemistry devices follow this clearance model.

Regulatory Peers - LAR Enzyme Immunoassay, Procainamide

All 24
Devices cleared under the same product code (LAR) and FDA review panel - the closest regulatory comparables to K010812.
ONLINE TDM PROCAINAMIDE
K060773 · Roche Diagnostics Corp. · Aug 2006
DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110
K032573 · Dade Behring, Inc. · Oct 2003
PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
K971716 · Bayer Corp. · Jun 1997
CEDIA N-ACETYLPROCAINAMIDE ASSAY
K963306 · Boehringer Mannheim Corp. · Oct 1996
CEDIA PROCAINAMIDE ASSAY
K962099 · Boehringer Mannheim Corp. · Aug 1996
PROCAINAMIDE ENZYME IMMUNOASSAY
K962463 · Diagnostic Reagents, Inc. · Aug 1996