Cleared Traditional

K863475 - THEOFAST(TM) TEST PACKAGE

K863475 is the FDA 510(k) clearance for THEOFAST(TM) TEST PACKAGE by 3M Company. It is a Class 2 Chemistry device (product code LER) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K863475 · 3M Company · Chemistry device
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Nov 1986
Decision
57d
Days
Class 2
Risk

K863475 is an FDA 510(k) clearance for the THEOFAST(TM) TEST PACKAGE. Classified as Fluorescent Immunoassay, Theophylline (product code LER), Class II - Special Controls.

Submitted by 3M Company (Mountain View, US). The FDA issued a Cleared decision on November 5, 1986 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3880 - the FDA in vitro diagnostics and chemistry 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 3M Company devices

Submission Details

510(k) Number K863475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1986
Decision Date November 05, 1986
Days to Decision 57 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 88d · This submission: 57d
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 Chemistry 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 K863475.
CEDIA(R) THEOPHYLLINE ASSAY/MODIFICATION
K905521 · Microgenics Corp. · Dec 1990
TURBOX THEOPHYLLINE ASSAY
K882570 · Unipath , Ltd. · Nov 1988
IMMPULSE COATED TUBE THEOPHYLLINE ASSAY REAGENTS
K864409 · Sclavo, Inc. · Dec 1986
TDX THEOPHYLLINE
K833070 · Abbott Laboratories · Nov 1983
AMWA TDA THEOPHYLLINE TEST
K831514 · Miles Laboratories, Inc. · Jun 1983
COBAS STANDARD FOR TOTAL PROTEIN
K823576 · Hoffmann-La Roche, Inc. · Jan 1983