Cleared Traditional

K801476 - APPLICATION OF EMIT THEOPHYLLINE ASSAY

K801476 is the FDA 510(k) clearance for APPLICATION OF EMIT THEOPHYLLINE ASSAY by Syva Co.. It is a Class 2 Toxicology device (product code KLS) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K801476 · Syva Co. · Toxicology device
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Jul 1980
Decision
14d
Days
Class 2
Risk

K801476 is an FDA 510(k) clearance for the APPLICATION OF EMIT THEOPHYLLINE ASSAY. Classified as Enzyme Immunoassay, Theophylline (product code KLS), Class II - Special Controls.

Submitted by Syva Co. (Walker, US). The FDA issued a Cleared decision on July 8, 1980 after a review of 14 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 Syva Co. devices

Submission Details

510(k) Number K801476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1980
Decision Date July 08, 1980
Days to Decision 14 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
73d faster than avg
Panel avg: 87d · This submission: 14d
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 55
Devices cleared under the same product code (KLS) and FDA review panel - the closest regulatory comparables to K801476.
A-GENT THEOPHYLLINE
K812003 · Abbott Laboratories · Jul 1981
BECKMAN THEOPHYLLINE REAGENT TEST KIT
K810578 · Beckman Instruments, Inc. · Mar 1981
ENDAB THEOPHYLLINE ENZYME IMMUNOASSAY
K802066 · Immunotech Corp. · Oct 1980
AMES TDA THEOPHYL-LINE TEST
K800646 · Miles Laboratories, Inc. · Apr 1980
EMIT THEOPHYLLINE ASSAY
K790256 · Syva Co. · Mar 1979