Cleared Traditional

K862067 - STRATUS DIGITOXIN FLUOROMETRIC ENZYME I...

K862067 is the FDA 510(k) clearance for STRATUS DIGITOXIN FLUOROMETRIC ENZYME I... by American Dade. It is a Class 2 Toxicology device (product code LFM) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K862067 · American Dade · Toxicology device
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Jun 1986
Decision
17d
Days
Class 2
Risk

K862067 is an FDA 510(k) clearance for the STRATUS DIGITOXIN FLUOROMETRIC ENZYME IMMUNOASSAY. Classified as Enzyme Immunoassay, Digitoxin (product code LFM), Class II - Special Controls.

Submitted by American Dade (Santa Ana, US). The FDA issued a Cleared decision on June 16, 1986 after a review of 17 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 American Dade devices

Submission Details

510(k) Number K862067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1986
Decision Date June 16, 1986
Days to Decision 17 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
70d faster than avg
Panel avg: 87d · This submission: 17d
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 K862067.
MILENIA (TM) DIGITOXIN
K900013 · Diagnostic Products Corp. · Mar 1990
CEDIA DIGITOXIN ASSAY
K896021 · Microgenics Corp. · Nov 1989
ACA(R) DIGITOXIN (DGTX) METHOD
K891094 · E.I. Dupont DE Nemours & Co., Inc. · Apr 1989
TDX DIGITOXIN
K842280 · Abbott Laboratories · Aug 1984
SOPHEIA/MP DIGITOXIN EIA KIT
K842578 · Diagnostic Products Corp. · Aug 1984
SOPHEIA DIGITOXIN EIA KIT & COMPONENTS
K830035 · Diagnostic Products Corp. · Jan 1983