Cleared Traditional

K853858 - IL TEST THEOPHYLLINE ASSAY

K853858 is the FDA 510(k) clearance for IL TEST THEOPHYLLINE ASSAY by Allied Instrumentation Laboratory. It is a Class 2 Toxicology device (product code KLS) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K853858 · Allied Instrumentation Laboratory · Toxicology device
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Oct 1985
Decision
29d
Days
Class 2
Risk

K853858 is an FDA 510(k) clearance for the IL TEST THEOPHYLLINE ASSAY. Classified as Enzyme Immunoassay, Theophylline (product code KLS), Class II - Special Controls.

Submitted by Allied Instrumentation Laboratory (Lexington, US). The FDA issued a Cleared decision on October 15, 1985 after a review of 29 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Allied Instrumentation Laboratory devices

Submission Details

510(k) Number K853858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1985
Decision Date October 15, 1985
Days to Decision 29 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 87d · This submission: 29d
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 56
Devices cleared under the same product code (KLS) and FDA review panel - the closest regulatory comparables to K853858.
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (THEO)
K861367 · Eastman Kodak Company · May 1986
IN VITRO TEST DETERMINATION OF THEOPHYLLINE
K854183 · Clinical Data, Inc. · Dec 1985
VISION THEOPHYLLINE
K853834 · Abbott Laboratories · Oct 1985
GEMSTAR IPA THEOPHYLLINE TEST KIT
K853372 · Electro-Nucleonics Laboratories, Inc. · Sep 1985
TECHNICON RA-1000 SYSTEM ANALYTE THEOPHYLLINE
K852573 · Technicon Instruments Corp. · Jul 1985
ACCULEVEL THEOPHYLLINE TEST(MODIFICATION)
K851741 · Syva Co. · Jun 1985