Cleared Traditional

K904305 - DUPONT DIMENSION GENTAMICIN(GENT) METHOD

K904305 is the FDA 510(k) clearance for DUPONT DIMENSION GENTAMICIN(GENT) METHOD by E.I. Dupont DE Nemours & Co., Inc.. It is a Class 2 Toxicology device (product code LCD) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K904305 · E.I. Dupont DE Nemours & Co., Inc. · Toxicology device
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Oct 1990
Decision
26d
Days
Class 2
Risk

K904305 is an FDA 510(k) clearance for the DUPONT DIMENSION(R) GENTAMICIN(GENT) METHOD. Classified as Enzyme Immunoassay, Gentamicin (product code LCD), Class II - Special Controls.

Submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on October 15, 1990 after a review of 26 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 E.I. Dupont DE Nemours & Co., Inc. devices

Submission Details

510(k) Number K904305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1990
Decision Date October 15, 1990
Days to Decision 26 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
61d faster than avg
Panel avg: 87d · This submission: 26d
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 30
Devices cleared under the same product code (LCD) and FDA review panel - the closest regulatory comparables to K904305.
ACS GENTAMICIN
K953020 · Ciba Corning Diagnostics Corp. · Aug 1995
IL TEST GENTAMICIN CALIBRATORS
K943982 · Instrumentation Laboratory CO · Jan 1995
CEDIA(R) GENTAMICIN ASSAY
K913470 · Microgenics Corp. · Sep 1991
IL GENTAMICIN ASSAY SYSTEM
K903743 · Instrumentation Laboratory CO · Sep 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