Cleared Traditional

K801084 - CYBREX GENTAMICIN

K801084 is an FDA 510(k) clearance for CYBREX GENTAMICIN, manufactured by Abbott Laboratories. The device is a Class 2 Toxicology device with product code LCQ cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K801084 · Abbott Laboratories · Toxicology device
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May 1980
Decision
16d
Days
Class 2
Risk

K801084 is an FDA 510(k) clearance for the CYBREX GENTAMICIN. Classified as Fluorescent Immunoassay Gentamicin (product code LCQ), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 23, 1980 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K801084

510(k) Number K801084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1980
Decision Date May 23, 1980
Days to Decision 16 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
71d faster than avg
Panel avg: 87d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LCQ Device Classification - Class 2, Special Controls

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 10
Devices cleared under the same product code (LCQ) and FDA review panel - the closest regulatory comparables to K801084.
SYVA ADVANCE SYST. EMIT-AMD GENT. ASSAY
K820285 · Syva Co. · Feb 1982
GENTAMICIN FLUORESCENT IMMUNOASSAY
K813539 · American Diagnostic Corp. · Dec 1981
AMES TDA GENTAMICIN TEST
K810942 · Miles Laboratories, Inc. · Apr 1981
FIAX TEST KIT FOR GENTAMICIN QUAN.
K800032 · Intl. Diagnostic Technology · Jan 1980