Cleared Traditional

K860464 - VISION THEOPHYLLINE - ADDIT. OF WHOLE B...

K860464 is an FDA 510(k) clearance for VISION THEOPHYLLINE - ADDIT. OF WHOLE B..., manufactured by Abbott Laboratories. The device is a Class 2 Toxicology device with product code KLS cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K860464 · Abbott Laboratories · Toxicology device
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Jun 1986
Decision
131d
Days
Class 2
Risk

K860464 is an FDA 510(k) clearance for the VISION THEOPHYLLINE - ADDIT. OF WHOLE BLOOD CLAIM. Classified as Enzyme Immunoassay, Theophylline (product code KLS), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on June 17, 1986 after a review of 131 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K860464

510(k) Number K860464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1986
Decision Date June 17, 1986
Days to Decision 131 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 87d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Toxicology devices follow this clearance model.

Regulatory Peers - KLS Enzyme Immunoassay, Theophylline

All 58
Devices cleared under the same product code (KLS) and FDA review panel - the closest regulatory comparables to K860464.
EMDS THEOPHYLLINE TESTPACKS ITEM #67662/95
K864041 · Em Diagnostic Systems, Inc. · Nov 1986
METHODS FOR THE DIMENSION CLINICAL CHEM. SYSTEM
K862955 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1986
EASY-TEST EMIT* THEOPHYLLINE(THEO) ITEM 67533/93
K862350 · Em Diagnostic Systems, Inc. · Jul 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