Cleared Traditional

K840758 - IMMPULSE THEOPHYLLINE ASSAY REAGENTS

K840758 is the FDA 510(k) clearance for IMMPULSE THEOPHYLLINE ASSAY REAGENTS by Paragon Diagnostics, Inc.. It is a Class 2 Toxicology device (product code LER) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K840758 · Paragon Diagnostics, Inc. · Toxicology device
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Apr 1984
Decision
41d
Days
Class 2
Risk

K840758 is an FDA 510(k) clearance for the IMMPULSE THEOPHYLLINE ASSAY REAGENTS. Classified as Fluorescent Immunoassay, Theophylline (product code LER), Class II - Special Controls.

Submitted by Paragon Diagnostics, Inc. (Walker, US). The FDA issued a Cleared decision on April 4, 1984 after a review of 41 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 Paragon Diagnostics, Inc. devices

Submission Details

510(k) Number K840758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1984
Decision Date April 04, 1984
Days to Decision 41 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 87d · This submission: 41d
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 13
Devices cleared under the same product code (LER) and FDA review panel - the closest regulatory comparables to K840758.
TURBOX THEOPHYLLINE ASSAY
K882570 · Unipath , Ltd. · Nov 1988
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
AMWA TDA THEOPHYLLINE TEST
K831514 · Miles Laboratories, Inc. · Jun 1983
COBAS STANDARD FOR TOTAL PROTEIN
K823576 · Hoffmann-La Roche, Inc. · Jan 1983