Cleared Traditional

K850060 - DU PONT GENTAMICIN ASSAY REAGENTS

K850060 is the FDA 510(k) clearance for DU PONT GENTAMICIN ASSAY REAGENTS 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 10-day FDA review.

K850060 · E.I. Dupont DE Nemours & Co., Inc. · Toxicology device
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Jan 1985
Decision
10d
Days
Class 2
Risk

K850060 is an FDA 510(k) clearance for the DU PONT GENTAMICIN ASSAY REAGENTS. 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 January 18, 1985 after a review of 10 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 K850060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 1985
Decision Date January 18, 1985
Days to Decision 10 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
77d faster than avg
Panel avg: 87d · This submission: 10d
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 K850060.
TECHNICON RA SYSTEMS/TOBRAMYCIN & GENTAMICIN
K860868 · Technicon Instruments Corp. · Apr 1986
DETERMINATION OF GENTAMICIN
K860045 · Clinical Data, Inc. · Jan 1986
ACA GENTAMICIN TEST PACK
K852672 · E.I. Dupont DE Nemours & Co., Inc. · Aug 1985
STRATUS GENTAMICIN FLUOROMETRIC ENZYM
K832445 · American Dade · Aug 1983
EMIT AMD GENTAMICIN ASSAY
K832056 · Syva Co. · Aug 1983
EMIT QST TOBRAMYCIN ASSAY
K831416 · Syva Co. · Jun 1983