Cleared Traditional

K823352 - IMMU-TRACE TRI-RAC R TRI-LEVEL CONTROLS

K823352 is the FDA 510(k) clearance for IMMU-TRACE TRI-RAC R TRI-LEVEL CONTROLS by American Dade. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K823352 · American Dade · Chemistry device
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Feb 1983
Decision
90d
Days
Class 1
Risk

K823352 is an FDA 510(k) clearance for the IMMU-TRACE TRI-RAC R TRI-LEVEL CONTROLS. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by American Dade (Mchenry, US). The FDA issued a Cleared decision on February 7, 1983 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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

Submission Details

510(k) Number K823352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1982
Decision Date February 07, 1983
Days to Decision 90 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
2d slower than avg
Panel avg: 88d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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 - JJY Multi-analyte Controls, All Kinds (assayed)

All 463
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K823352.
TITANGEL HIGH RESOLUTION CONTROL
K833639 · Helena Laboratories · Jan 1984
VENTREZYME EIA CONTROLS-IMMUNOASSAY
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ELECTROPHORESIS CONTROLS-3 IN 1
K831263 · Corning Medical & Scientific · Jul 1983
MULTIANALYTE CONTROLS-ALL KINDS
K823929 · Fisher Scientific Co., LLC · Jan 1983
ORTHO BI-LEVEL ASSAYED LIPID PROFILE
K823490 · Ortho Diagnostic Systems, Inc. · Jan 1983
MONI-TRO ES CHEMISTRY CONTROL LEVEL IX
K822850 · American Dade · Oct 1982