Cleared Traditional

RANDOX THEOPHYLLINE (K011771) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K011771 · Randox Laboratories, Ltd. · Chemistry device
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Jan 2002
Decision
225d
Days
Class 2
Risk

K011771 is an FDA 510(k) clearance for the RANDOX THEOPHYLLINE. Classified as Enzyme Immunoassay, Theophylline (product code KLS), Class II - Special Controls.

Submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on January 17, 2002 after a review of 225 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3880 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Randox Laboratories, Ltd. devices

Submission Details

510(k) Number K011771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2001
Decision Date January 17, 2002
Days to Decision 225 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 88d · This submission: 225d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K011771.
EMIT CAFFEINE ASSAY
K042407 · Dade Behring, Inc. · Oct 2004
ROCHE ONLINE THEOPHYLLINE
K020740 · Roche Diagnostics Corp. · Apr 2002
ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS
K993029 · Syva Co. · Jan 2000
CEDIA THEOPHYLLINE ASSAY
K961462 · Boehringer Mannheim Corp. · Jun 1996
IMMULITE THEOPHYLLINE
K954569 · Diagnostic Products Corp. · Nov 1995
IL TEST THEOPHYLLINE
K943979 · Instrumentation Laboratory CO · Jan 1995