Cleared Traditional

K903095 - IL THYROXINE (T4) ASSAY SYSTEM

K903095 is the FDA 510(k) clearance for IL THYROXINE (T4) ASSAY SYSTEM by Instrumentation Laboratory CO. It is a Class 2 Chemistry device (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

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
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.

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 48
Devices cleared under the same product code (KLI) and FDA review panel - the closest regulatory comparables to K903095.
VISTA THYROXINE (T-4) ASSAY -- MODIFICATION
K922433 · Syva Co. · Sep 1992
CEDIA T4
K915194 · Boehringer Mannheim Corp. · Dec 1991
TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTES
K912616 · Technicon Instruments Corp. · Sep 1991
NDS THYROXINE TEST KIT & NDS THYROXINE CALIBRATOR
K897072 · Kallestad Diag, A Div. of Erbamont, Inc. · Mar 1990
EMIT CONVENIENCE PACK: THYROXINE ASSAY
K890831 · Syva Co. · Apr 1989
THYROXINE MICROASSAY
K884260 · Diamedix Corp. · Feb 1989