Cleared Traditional

VISION THEOPHYLLINE II (K896927) - FDA 510(k) Clearance

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

K896927 · Abbott Laboratories · Toxicology device
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Jan 1990
Decision
37d
Days
Class 2
Risk

K896927 is an FDA 510(k) clearance for the VISION THEOPHYLLINE II. 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 January 18, 1990 after a review of 37 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 Abbott Laboratories devices

Submission Details

510(k) Number K896927 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1989
Decision Date January 18, 1990
Days to Decision 37 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 87d · This submission: 37d
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 40
Devices cleared under the same product code (KLS) and FDA review panel - the closest regulatory comparables to K896927.
EMIT(R) 2000 THEOPHYLLINE ASSAY/CALIBRATORS
K913123 · Syva Co. · Sep 1991
IL THEOPHYLLINE ASSAY SYSTEM
K910697 · Instrumentation Laboratory CO · Apr 1991
TECHNICON IMMUNO I(TM) SYSTEM AND ANALYTES
K902243 · Technicon Instruments Corp. · Jul 1990
ACCULEVEL ONE-STEP THEOPHYLLINE TEST
K885253 · Syva Co. · Mar 1989
COAT-A-COUNT (TM) THEOPHYLLINE
K890002 · Diagnostic Products Corp. · Jan 1989
EMIT CONVENIENCE PACK: THEOPHYLLINE ASSAY
K874578 · Syva Co. · Nov 1987