Cleared Traditional

K803046 - IMMU-TRACE T4 RIA PROCEDURE

K803046 is an FDA 510(k) clearance for IMMU-TRACE T4 RIA PROCEDURE, manufactured by American Dade. The device is a Class 2 Chemistry device with product code CDX cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K803046 · American Dade · Chemistry device
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Jan 1981
Decision
32d
Days
Class 2
Risk

K803046 is an FDA 510(k) clearance for the IMMU-TRACE T4 RIA PROCEDURE. Classified as Radioimmunoassay, Total Thyroxine (product code CDX), Class II - Special Controls.

Submitted by American Dade (Mchenry, US). The FDA issued a Cleared decision on January 2, 1981 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1700 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all American Dade devices

FDA 510(k) Submission Details - K803046

510(k) Number K803046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1980
Decision Date January 02, 1981
Days to Decision 32 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
56d faster than avg
Panel avg: 88d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CDX Device Classification - Class 2, Special Controls

Product Code CDX Radioimmunoassay, Total Thyroxine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CDX Radioimmunoassay, Total Thyroxine

All 93
Devices cleared under the same product code (CDX) and FDA review panel - the closest regulatory comparables to K803046.
QUANTAPHASE T-4 RIA
K811787 · Bio-Rad · Jul 1981
COAT-A-COUNT T4 RIA KIT
K811315 · Diagnostic Products Corp. · May 1981
125 I-T4 RIA TEST KIT
K811070 · Intl. Immunoassay Laboratories, Inc. · Apr 1981
SERUM T4 BY ENZYME IMMUNOASSAY
K802573 · Worthington Diagnostic Systems · Nov 1980
T4 RADIOIMMUNOASSAY KIT
K802469 · American Diagnostic Corp. · Nov 1980
T4-SQUIBB RIA KIT
K802456 · E. R. Squibb & Sons, Inc. · Oct 1980