Cleared Traditional

K903383 - TDX FREE T4 CALCULATION

K903383 is an FDA 510(k) clearance for TDX FREE T4 CALCULATION, manufactured by Abbott Laboratories. The device is a Class 2 Chemistry device with product code CEC cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K903383 · Abbott Laboratories · Chemistry device
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Sep 1990
Decision
45d
Days
Class 2
Risk

K903383 is an FDA 510(k) clearance for the TDX FREE T4 CALCULATION. Classified as Radioimmunoassay, Free Thyroxine (product code CEC), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on September 10, 1990 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1695 - 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

FDA 510(k) Submission Details - K903383

510(k) Number K903383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1990
Decision Date September 10, 1990
Days to Decision 45 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
43d faster than avg
Panel avg: 88d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CEC Device Classification - Class 2, Special Controls

Product Code CEC Radioimmunoassay, Free Thyroxine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1695
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 - CEC Radioimmunoassay, Free Thyroxine

All 66
Devices cleared under the same product code (CEC) and FDA review panel - the closest regulatory comparables to K903383.
AFFINITY FREE T4 TEST SYSTEM
K912698 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1991
MICROZYME(TM) FREE T4 ENZYME IMMUNOASSAY TEST
K911634 · Immunotech Corp. · Jun 1991
CIBA CORNING ACS FT4 IMMUNOASSAY
K910684 · Ciba Corning Diagnostics Corp. · May 1991
IMX FREE T4 CALCULATION
K903384 · Abbott Laboratories · Sep 1990
ABBOTT IMX FREE T4
K902834 · Abbott Laboratories · Sep 1990
ENZYMUN TEST(R) FT4 (FREE THYROXINE)
K900883 · Boehringer Mannheim Corp. · May 1990