Cleared Traditional

K831514 - AMWA TDA THEOPHYLLINE TEST

K831514 is the FDA 510(k) clearance for AMWA TDA THEOPHYLLINE TEST by Miles Laboratories, Inc.. It is a Class 2 Toxicology device (product code LER) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K831514 · Miles Laboratories, Inc. · Toxicology device
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Jun 1983
Decision
49d
Days
Class 2
Risk

K831514 is an FDA 510(k) clearance for the AMWA TDA THEOPHYLLINE TEST. Classified as Fluorescent Immunoassay, Theophylline (product code LER), Class II - Special Controls.

Submitted by Miles Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 30, 1983 after a review of 49 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 Miles Laboratories, Inc. devices

Submission Details

510(k) Number K831514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1983
Decision Date June 30, 1983
Days to Decision 49 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
38d faster than avg
Panel avg: 87d · This submission: 49d
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 K831514.
IMMPULSE COATED TUBE THEOPHYLLINE ASSAY REAGENTS
K864409 · Sclavo, Inc. · Dec 1986
THEOFAST(TM) TEST PACKAGE
K863475 · 3M Company · Nov 1986
TDX THEOPHYLLINE
K833070 · Abbott Laboratories · Nov 1983
COBAS STANDARD FOR TOTAL PROTEIN
K823576 · Hoffmann-La Roche, Inc. · Jan 1983
AMERIFLUOR THEOPHYLLINE FLUORESCENT IMM
K820397 · American Diagnostic Corp. · Mar 1982
EMIT-AAD THEOPHYLLINE ASSAY
K813240 · Syva Co. · Dec 1981