Cleared Traditional

K891093 - ACA (R) DIGITOXIN CALIBRATOR (FDA 510(k) Clearance)

Class I Toxicology device.

K891093 · E.I. Dupont DE Nemours & Co., Inc. · Toxicology device
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Apr 1989
Decision
55d
Days
Class 1
Risk

K891093 is an FDA 510(k) clearance for the ACA (R) DIGITOXIN CALIBRATOR. Classified as Beta-globulin, Antigen, Antiserum, Control (product code DCJ), Class I - General Controls.

Submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on April 26, 1989 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 866.5160 - 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 E.I. Dupont DE Nemours & Co., Inc. devices

Submission Details

510(k) Number K891093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1989
Decision Date April 26, 1989
Days to Decision 55 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 87d · This submission: 55d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DCJ Beta-globulin, Antigen, Antiserum, Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.5160
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.