Cleared Traditional

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

K823352 is an FDA 510(k) clearance for IMMU-TRACE TRI-RAC R TRI-LEVEL CONTROLS, manufactured by American Dade. The device is a Class 1 Chemistry device with 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

FDA 510(k) Submission Details - K823352

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.

JJY Device Classification - Class 1, General Controls

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 594
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