Cleared Traditional

IL TEST THEOPHYLLINE (K943979) - FDA 510(k) Clearance

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

K943979 · Instrumentation Laboratory CO · Toxicology device
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Optimized for regulatory review, auditing and printing
Jan 1995
Decision
225d
Days
Class 2
Risk

K943979 is an FDA 510(k) clearance for the IL TEST THEOPHYLLINE. Classified as Enzyme Immunoassay, Theophylline (product code KLS), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on January 18, 1995 after a review of 225 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3880 - the FDA toxicology device 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 Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K943979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1994
Decision Date January 18, 1995
Days to Decision 225 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
138d slower than avg
Panel avg: 87d · 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 Toxicology 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 K943979.
AXSYM THEOPHYLLINE
K935373 · Abbott Laboratories · Jun 1994
ABBOTT VISION THEOPHYLLINE IIA
K926245 · Abbott Laboratories · May 1993
VISION THEOPHYLLINE II
K896927 · Abbott Laboratories · Jan 1990
VISION THEOPHYLLINE - ADDIT. OF WHOLE BLOOD CLAIM
K860464 · Abbott Laboratories · Jun 1986
VISION THEOPHYLLINE
K853834 · Abbott Laboratories · Oct 1985
THEOPHYLLINE RADIOIMMUNOASSAY ARIA HT SYSTEM
K844170 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1984