Cleared Traditional

K820296 - STRATUS TDM CONTROL, LEVELS I,II,III (FDA 510(k) Clearance)

Class I Chemistry device.

K820296 · American Dade · Chemistry device
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May 1982
Decision
99d
Days
Class 1
Risk

K820296 is an FDA 510(k) clearance for the STRATUS TDM CONTROL, LEVELS I,II,III. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by American Dade (Mchenry, US). The FDA issued a Cleared decision on May 14, 1982 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3280 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K820296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1982
Decision Date May 14, 1982
Days to Decision 99 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 88d · This submission: 99d
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.