Cleared Traditional

K813240 - EMIT-AAD THEOPHYLLINE ASSAY

K813240 is the FDA 510(k) clearance for EMIT-AAD THEOPHYLLINE ASSAY by Syva Co.. It is a Class 2 Toxicology device (product code LER) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K813240 · Syva Co. · Toxicology device
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Dec 1981
Decision
16d
Days
Class 2
Risk

K813240 is an FDA 510(k) clearance for the EMIT-AAD THEOPHYLLINE ASSAY. Classified as Fluorescent Immunoassay, Theophylline (product code LER), Class II - Special Controls.

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on December 3, 1981 after a review of 16 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 K813240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1981
Decision Date December 03, 1981
Days to Decision 16 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
71d faster than avg
Panel avg: 87d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LER Fluorescent 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 - LER Fluorescent Immunoassay, Theophylline

All 12
Devices cleared under the same product code (LER) and FDA review panel - the closest regulatory comparables to K813240.
AMWA TDA THEOPHYLLINE TEST
K831514 · Miles Laboratories, Inc. · Jun 1983
COBAS STANDARD FOR TOTAL PROTEIN
K823576 · Hoffmann-La Roche, Inc. · Jan 1983
AMERIFLUOR THEOPHYLLINE FLUORESCENT IMM
K820397 · American Diagnostic Corp. · Mar 1982
AMES TDA THEOPHYLLINE TEST
K812518 · Miles Laboratories, Inc. · Sep 1981
FLUOROMATIC THEOPHYLLINE FIA
K811856 · Bio-Rad · Jul 1981
AMES TDA THEOPHYLLINE TEST
K810943 · Miles Laboratories, Inc. · Apr 1981