Cleared Traditional

TDX FREE T3 CALCULATION (K903433) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K903433 · Abbott Laboratories · Chemistry device
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Oct 1990
Decision
73d
Days
Class 2
Risk

K903433 is an FDA 510(k) clearance for the TDX FREE T3 CALCULATION. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on October 12, 1990 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1710 - 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 Abbott Laboratories devices

Submission Details

510(k) Number K903433 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1990
Decision Date October 12, 1990
Days to Decision 73 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
15d faster than avg
Panel avg: 88d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CDP Radioimmunoassay, Total Triiodothyronine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1710
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 - CDP Radioimmunoassay, Total Triiodothyronine

All 42
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K903433.
TECHNICON IMMUNO 1 SYSTEM TOTAL TRIIODOTHYRONINE
K923258 · Heraeus Kulzer, Inc. · Sep 1992
MILENIA TOTAL T3
K914467 · Diagnostic Products Corp. · Feb 1992
IMX FREE TRIIODOTHYRONINE
K905261 · Abbott Laboratories · Jan 1991
IMX FREE T3 CALCULATION
K903432 · Abbott Laboratories · Sep 1990
ENZYMUN TEST R T3
K896900 · Boehringer Mannheim Corp. · Feb 1990
ABBOTT TDX TOTAL T3 PLUS
K894238 · Abbott Laboratories · Oct 1989