Cleared Traditional

K860045 - DETERMINATION OF GENTAMICIN

K860045 is the FDA 510(k) clearance for DETERMINATION OF GENTAMICIN by Clinical Data, Inc.. It is a Class 2 Toxicology device (product code LCD) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K860045 · Clinical Data, Inc. · Toxicology device
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Jan 1986
Decision
16d
Days
Class 2
Risk

K860045 is an FDA 510(k) clearance for the DETERMINATION OF GENTAMICIN. Classified as Enzyme Immunoassay, Gentamicin (product code LCD), Class II - Special Controls.

Submitted by Clinical Data, Inc. (Boston, US). The FDA issued a Cleared decision on January 22, 1986 after a review of 16 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 Clinical Data, Inc. devices

Submission Details

510(k) Number K860045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1986
Decision Date January 22, 1986
Days to Decision 16 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 87d · This submission: 16d
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 29
Devices cleared under the same product code (LCD) and FDA review panel - the closest regulatory comparables to K860045.
EASY-TEST EMIT GENTAMICIN (GENT) ITEM NO. 16640
K871329 · Em Diagnostic Systems, Inc. · May 1987
EMIT CHLORAMPHENICOL ASSAY/BI-LEVEL CONTROLS
K862260 · Syva Co. · Nov 1986
TECHNICON RA SYSTEMS/TOBRAMYCIN & GENTAMICIN
K860868 · Technicon Instruments Corp. · Apr 1986
ACA GENTAMICIN TEST PACK
K852672 · E.I. Dupont DE Nemours & Co., Inc. · Aug 1985
DU PONT GENTAMICIN ASSAY REAGENTS
K850060 · E.I. Dupont DE Nemours & Co., Inc. · Jan 1985
STRATUS GENTAMICIN FLUOROMETRIC ENZYM
K832445 · American Dade · Aug 1983