Cleared Traditional

K842578 - SOPHEIA/MP DIGITOXIN EIA KIT

K842578 is the FDA 510(k) clearance for SOPHEIA/MP DIGITOXIN EIA KIT by Diagnostic Products Corp.. It is a Class 2 Toxicology device (product code LFM) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K842578 · Diagnostic Products Corp. · Toxicology device
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Aug 1984
Decision
40d
Days
Class 2
Risk

K842578 is an FDA 510(k) clearance for the SOPHEIA/MP DIGITOXIN EIA KIT. Classified as Enzyme Immunoassay, Digitoxin (product code LFM), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Mchenry, US). The FDA issued a Cleared decision on August 12, 1984 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3300 - 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 Diagnostic Products Corp. devices

Submission Details

510(k) Number K842578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1984
Decision Date August 12, 1984
Days to Decision 40 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
47d faster than avg
Panel avg: 87d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LFM Enzyme Immunoassay, Digitoxin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3300
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 - LFM Enzyme Immunoassay, Digitoxin

All 16
Devices cleared under the same product code (LFM) and FDA review panel - the closest regulatory comparables to K842578.
ACA(R) DIGITOXIN (DGTX) METHOD
K891094 · E.I. Dupont DE Nemours & Co., Inc. · Apr 1989
STRATUS DIGITOXIN FLUOROMETRIC ENZYME IMMUNOASSAY
K862067 · American Dade · Jun 1986
TDX DIGITOXIN
K842280 · Abbott Laboratories · Aug 1984
SOPHEIA DIGITOXIN EIA KIT & COMPONENTS
K830035 · Diagnostic Products Corp. · Jan 1983