Cleared Special

K011166 - MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229

K011166 is an FDA 510(k) clearance for MODIFICATION TO EMIT 2000 THEOPHYLLINE ..., manufactured by Syva Co., Dade Behring, Inc.. The device is a Class 2 Chemistry device with product code KLS cleared through the Special 510(k) pathway after a 24-day FDA review.

K011166 · Syva Co., Dade Behring, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K011166

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 89d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

KLS Device Classification - Class 2, Special Controls

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.
ROCHE ONLINE THEOPHYLLINE
K020740 · Roche Diagnostics Corp. · Apr 2002
RANDOX THEOPHYLLINE
K011771 · Randox Laboratories, Ltd. · Jan 2002
ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY
K013272 · Bayer Corp. · Oct 2001
ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS
K993029 · Syva Co. · Jan 2000
ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS
K973583 · Schiapparelli Biosystems, Inc. · Nov 1997
ACCUMETER THEOPHYLLINE TEST
K972495 · Chemtrak, Inc. · Oct 1997
K011166 · MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229
Download PDF FDA Summary Syva Co., Dade Behrin…