Cleared Special

MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229 (K011166) - FDA 510(k) Clearance

Class II Chemistry device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K011166 · Syva Co., Dade Behring, Inc. · Chemistry device
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May 2001
Decision
24d
Days
Class 2
Risk

K011166 is an FDA 510(k) clearance for the MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229. Classified as Enzyme Immunoassay, Theophylline (product code KLS), Class II - Special Controls.

Submitted by Syva Co., Dade Behring, Inc. (San Jose, US). The FDA issued a Cleared decision on May 10, 2001 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3880 - 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 K011166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2001
Decision Date May 10, 2001
Days to Decision 24 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
64d faster than avg
Panel avg: 88d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KLS Enzyme Immunoassay, Theophylline
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3880
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 - KLS Enzyme Immunoassay, Theophylline

All 70
Devices cleared under the same product code (KLS) and FDA review panel - the closest regulatory comparables to K011166.
EMIT CAFFEINE ASSAY
K042407 · Dade Behring, Inc. · Oct 2004
ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS
K993029 · Syva Co. · Jan 2000
CEDIA THEOPHYLLINE ASSAY
K961462 · Boehringer Mannheim Corp. · Jun 1996
AXSYM THEOPHYLLINE
K935373 · Abbott Laboratories · Jun 1994
ABBOTT VISION THEOPHYLLINE IIA
K926245 · Abbott Laboratories · May 1993
EMIT(R) 2000 THEOPHYLLINE ASSAY/CALIBRATORS
K913123 · Syva Co. · Sep 1991