Cleared Traditional

K955569 - INNOFLUOR GENTAMICIN ASSAY SYSTEM

K955569 is an FDA 510(k) clearance for INNOFLUOR GENTAMICIN ASSAY SYSTEM, manufactured by Oxis Intl., Inc.. The device is a Class 2 Toxicology device with product code LCQ cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K955569 · Oxis Intl., Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
65d
Days
Class 2
Risk

K955569 is an FDA 510(k) clearance for the INNOFLUOR GENTAMICIN ASSAY SYSTEM. Classified as Fluorescent Immunoassay Gentamicin (product code LCQ), Class II - Special Controls.

Submitted by Oxis Intl., Inc. (Portland, US). The FDA issued a Cleared decision on February 9, 1996 after a review of 65 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 Oxis Intl., Inc. devices

FDA 510(k) Submission Details - K955569

510(k) Number K955569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1995
Decision Date February 09, 1996
Days to Decision 65 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 87d · This submission: 65d
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 12
Devices cleared under the same product code (LCQ) and FDA review panel - the closest regulatory comparables to K955569.
VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM
K972609 · Bio-Rad · Aug 1997
COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORS
K945523 · Roche Diagnostic Systems, Inc. · Mar 1995
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