Cleared Traditional

K813539 - GENTAMICIN FLUORESCENT IMMUNOASSAY

K813539 is the FDA 510(k) clearance for GENTAMICIN FLUORESCENT IMMUNOASSAY by American Diagnostic Corp.. It is a Class 2 Toxicology device (product code LCQ) cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K813539 · American Diagnostic Corp. · Toxicology device
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Dec 1981
Decision
10d
Days
Class 2
Risk

K813539 is an FDA 510(k) clearance for the GENTAMICIN FLUORESCENT IMMUNOASSAY. Classified as Fluorescent Immunoassay Gentamicin (product code LCQ), Class II - Special Controls.

Submitted by American Diagnostic Corp. (Walker, US). The FDA issued a Cleared decision on December 31, 1981 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 American Diagnostic Corp. devices

Submission Details

510(k) Number K813539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1981
Decision Date December 31, 1981
Days to Decision 10 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
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 LCQ Fluorescent 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 - LCQ Fluorescent Immunoassay Gentamicin

All 8
Devices cleared under the same product code (LCQ) and FDA review panel - the closest regulatory comparables to K813539.
'TDXFLX ANALYZER
K904226 · Abbott Laboratories · Oct 1990
COBAS REAGENTS FOR GENTAMICIN & CALIBRAT
K843827 · Roche Diagnostic Systems, Inc. · Feb 1985
SYVA ADVANCE SYST. EMIT-AMD GENT. ASSAY
K820285 · Syva Co. · Feb 1982
AMES TDA GENTAMICIN TEST
K810942 · Miles Laboratories, Inc. · Apr 1981
CYBREX GENTAMICIN
K801084 · Abbott Laboratories · May 1980