Cleared Special

K011605 - EMIT 2000 QUINIDINE ASSAY

K011605 is the FDA 510(k) clearance for EMIT 2000 QUINIDINE ASSAY by Syva Co., Dade Behring, Inc.. It is a Class 2 Toxicology device (product code LBZ) cleared through the Special 510(k) pathway after a 19-day FDA review.

K011605 · Syva Co., Dade Behring, Inc. · Toxicology device
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Jun 2001
Decision
19d
Days
Class 2
Risk

K011605 is an FDA 510(k) clearance for the EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229. Classified as Enzyme Immunoassay, Quinidine (product code LBZ), Class II - Special Controls.

Submitted by Syva Co., Dade Behring, Inc. (San Jose, US). The FDA issued a Cleared decision on June 12, 2001 after a review of 19 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 K011605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2001
Decision Date June 12, 2001
Days to Decision 19 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
68d faster than avg
Panel avg: 87d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LBZ Enzyme Immunoassay, Quinidine
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 - LBZ Enzyme Immunoassay, Quinidine

All 22
Devices cleared under the same product code (LBZ) and FDA review panel - the closest regulatory comparables to K011605.
ROCHE ONLINE TDM QUINIDINE
K032332 · Roche Diagnostics Corp. · Jan 2004
QUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
K964116 · Bayer Corp. · Dec 1996
QUINIDINE ENZYME IMMUNOASSAY
K964212 · Diagnostic Reagents, Inc. · Dec 1996
COBAS-FP QUINIDINE REAGENTS AND CALIBRATORS
K941440 · Roche Diagnostic Systems, Inc. · Jul 1994
EMIT 2000 QUINDINE ASSAY QUIDIDINE CALIBRATORS
K922913 · Syva Co. · Aug 1992
EMIT CONVENIENCE PACK, QUINIDINE ASSAY/CALIBRATORS
K904990 · Syva Co. · Feb 1991