Cleared Traditional

K890689 - ADX TM OPIATES (FDA 510(k) Clearance)

Class I Toxicology device.

K890689 · Abbott Laboratories · Toxicology device
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Aug 1989
Decision
192d
Days
Class 1
Risk

K890689 is an FDA 510(k) clearance for the ADX TM OPIATES. Classified as Colostrum, Antigen, Antiserum, Control (product code DGJ), Class I - General Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 25, 1989 after a review of 192 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 866.5230 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K890689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1989
Decision Date August 25, 1989
Days to Decision 192 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d slower than avg
Panel avg: 87d · This submission: 192d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DGJ Colostrum, Antigen, Antiserum, Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.5230
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.