Cleared Traditional

K855227 - MICRO-EIA THEOPHYLLINE TEST KIT MONOCLONAL

K855227 is the FDA 510(k) clearance for MICRO-EIA THEOPHYLLINE TEST KIT MONOCLONAL by Bioclinical Systems, Inc.. It is a Class 2 Toxicology device (product code KLS) cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K855227 · Bioclinical Systems, Inc. · Toxicology device
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Apr 1986
Decision
102d
Days
Class 2
Risk

K855227 is an FDA 510(k) clearance for the MICRO-EIA THEOPHYLLINE TEST KIT MONOCLONAL. Classified as Enzyme Immunoassay, Theophylline (product code KLS), Class II - Special Controls.

Submitted by Bioclinical Systems, Inc. (St.Louis, US). The FDA issued a Cleared decision on April 11, 1986 after a review of 102 days - within the typical 510(k) review window.

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.

View all Bioclinical Systems, Inc. devices

Submission Details

510(k) Number K855227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1985
Decision Date April 11, 1986
Days to Decision 102 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 87d · This submission: 102d
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 K855227.
VISION THEOPHYLLINE - ADDIT. OF WHOLE BLOOD CLAIM
K860464 · Abbott Laboratories · Jun 1986
EMIT CAFFEINE ASSAY
K853872 · Syva Co. · Jun 1986
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