Cleared Traditional

K903743 - IL GENTAMICIN ASSAY SYSTEM

K903743 is the FDA 510(k) clearance for IL GENTAMICIN ASSAY SYSTEM by Instrumentation Laboratory CO. It is a Class 2 Toxicology device (product code LCD) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K903743 · Instrumentation Laboratory CO · Toxicology device
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Sep 1990
Decision
32d
Days
Class 2
Risk

K903743 is an FDA 510(k) clearance for the IL GENTAMICIN ASSAY SYSTEM. Classified as Enzyme Immunoassay, Gentamicin (product code LCD), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on September 17, 1990 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3450 - the FDA toxicology device 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 K903743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1990
Decision Date September 17, 1990
Days to Decision 32 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 87d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LCD Enzyme Immunoassay, Gentamicin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3450
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 Toxicology devices follow this clearance model.

Regulatory Peers - LCD Enzyme Immunoassay, Gentamicin

All 28
Devices cleared under the same product code (LCD) and FDA review panel - the closest regulatory comparables to K903743.
IL TEST GENTAMICIN CALIBRATORS
K943982 · Instrumentation Laboratory CO · Jan 1995
CEDIA(R) GENTAMICIN ASSAY
K913470 · Microgenics Corp. · Sep 1991
DUPONT DIMENSION(R) GENTAMICIN(GENT) METHOD
K904305 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1990
STRATUS(R) GENTAMICIN FLUOROMETRIC ENZYME IMMUNO.
K895484 · Baxter Healthcare Corp · Oct 1989
TECHNICON RA SYSTEMS GENTAMICIN TEST METHOD
K893912 · Technicon Instruments Corp. · Aug 1989
EMIT CONVENIENCE PACK: GENTAMICIN ASSAY
K874703 · Syva Co. · Dec 1987