Cleared Traditional

K820296 - STRATUS TDM CONTROL, LEVELS I,II,III

K820296 is an FDA 510(k) clearance for STRATUS TDM CONTROL, manufactured by American Dade. The device is a Class 1 Chemistry device with product code DIF cleared through the Traditional 510(k) pathway after a 99-day FDA review.

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.

View all American Dade devices

FDA 510(k) Submission Details - K820296

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 88d · This submission: 99d
Pathway characteristics
Predicate-based equivalence.

DIF Device Classification - Class 1, General Controls

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.

Regulatory Peers - DIF Drug Mixture Control Materials

All 175
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K820296.
ORTHO*-BI-LEVEL ASSAYED WHOLE BLOOD TOX
K821975 · Ortho Diagnostic Systems, Inc. · Aug 1982
Q-PAK URINE TOXICOLOGY CONTROL UNASSAYED
K821950 · Travenol Laboratories, S.A. · Jul 1982
Q-PAK URINE TOXICOLOGY CONTROL, UNASSAY.
K821973 · Travenol Laboratories, S.A. · Jul 1982
PROFILE GENERAL SET ASSAYED SERUM CONTR
K820468 · General Diagnostics · Mar 1982
EMIT-ST URINE CONTROLS SET A #3A349
K820462 · Syva Co. · Mar 1982
CONTROL SET
K820191 · Syva Co. · Feb 1982