Cleared Traditional

K894523 - FPR GENTAMICIN KIT

K894523 is an FDA 510(k) clearance for FPR GENTAMICIN KIT, manufactured by Colony Laboratories, Inc.. The device is a Class 2 Toxicology device with product code LCQ cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K894523 · Colony Laboratories, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1989
Decision
70d
Days
Class 2
Risk

K894523 is an FDA 510(k) clearance for the FPR GENTAMICIN KIT. Classified as Fluorescent Immunoassay Gentamicin (product code LCQ), Class II - Special Controls.

Submitted by Colony Laboratories, Inc. (Washington, US). The FDA issued a Cleared decision on September 28, 1989 after a review of 70 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 Colony Laboratories, Inc. devices

FDA 510(k) Submission Details - K894523

510(k) Number K894523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1989
Decision Date September 28, 1989
Days to Decision 70 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 87d · This submission: 70d
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 13
Devices cleared under the same product code (LCQ) and FDA review panel - the closest regulatory comparables to K894523.
GENTAMICIN FPIA REAGENT SET AND CALIBRATORS
K943550 · Sigma Diagnostics, Inc. · Nov 1994
OPUS GENTAMICIN
K905721 · Pb Diagnostic Systems, Inc. · Feb 1991
'TDXFLX ANALYZER
K904226 · Abbott Laboratories · Oct 1990
GENTAMICIN KIT(FPIA)
K852013 · Windsor Laboratories, Inc. · Jun 1985
COBAS REAGENTS FOR GENTAMICIN & CALIBRAT
K843827 · Roche Diagnostic Systems, Inc. · Feb 1985
SYVA ADVANCE SYST. EMIT-AMD GENT. ASSAY
K820285 · Syva Co. · Feb 1982