Cleared Traditional

IL THYROXINE (T4) ASSAY SYSTEM (K903095) - FDA 510(k) Clearance

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

K903095 · Instrumentation Laboratory CO · Chemistry device
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Aug 1990
Decision
41d
Days
Class 2
Risk

K903095 is an FDA 510(k) clearance for the IL THYROXINE (T4) ASSAY SYSTEM. Classified as Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine (product code KLI), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on August 23, 1990 after a review of 41 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 Instrumentation Laboratory CO devices

Submission Details

510(k) Number K903095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1990
Decision Date August 23, 1990
Days to Decision 41 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 88d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLI Enzyme Immunoassay, Non-radiolabeled, 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 - KLI Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine

All 85
Devices cleared under the same product code (KLI) and FDA review panel - the closest regulatory comparables to K903095.
ABBOTT ARCHITECT TOTAL T4
K983440 · Abbott Laboratories · Nov 1998
VISION(R) THYROXINE (T4)
K880662 · Abbott Laboratories · Mar 1988
AFFINITY TOTAL THYROXINE IMMUNIT
K873518 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1987
TDX THYROXINE
K830683 · Abbott Laboratories · Apr 1983
A-GENT QUANTICHROM T4 11A
K790848 · Abbott Laboratories · Aug 1979