Cleared Traditional

K892380 - DADE(R) IMMUNOASSAY CONTROLS, LEVELS I, II, III (FDA 510(k) Clearance)

Class I Toxicology device.

K892380 · Baxter Healthcare Corp · Toxicology device
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Feb 1990
Decision
308d
Days
Class 1
Risk

K892380 is an FDA 510(k) clearance for the DADE(R) IMMUNOASSAY CONTROLS, LEVELS I, II, III. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Baxter Healthcare Corp (Miami, US). The FDA issued a Cleared decision on February 8, 1990 after a review of 308 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3280 - 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. Elevated predicate reliance profile. 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 K892380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1989
Decision Date February 08, 1990
Days to Decision 308 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
221d slower than avg
Panel avg: 87d · This submission: 308d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DIF Drug Mixture Control Materials
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3280
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.