Cleared Traditional

K903095 - IL THYROXINE (T4) ASSAY SYSTEM

K903095 is an FDA 510(k) clearance for IL THYROXINE (T4) ASSAY SYSTEM, manufactured by Instrumentation Laboratory CO. The device is a Class 2 Chemistry device with product code KLI cleared through the Traditional 510(k) pathway after a 41-day FDA review.

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

FDA 510(k) Submission Details - K903095

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
Combination Product No
PCCP Authorized No
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.

KLI Device Classification - Class 2, Special Controls

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 70
Devices cleared under the same product code (KLI) and FDA review panel - the closest regulatory comparables to K903095.
CEDIA T4
K915194 · Boehringer Mannheim Corp. · Dec 1991
TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTES
K912616 · Technicon Instruments Corp. · Sep 1991
SR1 T4 ENZYME IMMUNOASSAY (MAGNETIC SOLID-PHASE)
K911217 · Serono-Baker Diagnostics, Inc. · Aug 1991
NDS THYROXINE TEST KIT & NDS THYROXINE CALIBRATOR
K897072 · Kallestad Diag, A Div. of Erbamont, Inc. · Mar 1990
OPUS T4 TEST SYSTEM
K897193 · Pb Diagnostic Systems, Inc. · Mar 1990
THYROXIN(T4) ENZYME IMMUNOASSAY TEST KIT
K897144 · Medix Biotech, Inc. · Mar 1990