Cleared Traditional

K955570 - INNOFLUOR AMIKACIN ASSAY SYSTEM

K955570 is an FDA 510(k) clearance for INNOFLUOR AMIKACIN ASSAY SYSTEM, manufactured by Oxis Intl., Inc.. The device is a Class 2 Toxicology device with product code KLQ cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K955570 · 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

K955570 is an FDA 510(k) clearance for the INNOFLUOR AMIKACIN ASSAY SYSTEM. Classified as Radioimmunoassay, Amikacin (product code KLQ), 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 862.3035 - 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 - K955570

510(k) Number K955570 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.

KLQ Device Classification - Class 2, Special Controls

Product Code KLQ Radioimmunoassay, Amikacin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3035
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 - KLQ Radioimmunoassay, Amikacin

All 15
Devices cleared under the same product code (KLQ) and FDA review panel - the closest regulatory comparables to K955570.
QMS AMIKACIN REAGENTS
K052815 · Seradyn, Inc. · Nov 2005
RANDOX AMIKACIN
K033884 · Randox Laboratories, Ltd. · Jun 2004
INNOFLUOR (TM) AMIKACIN REAGENT SET
K903100 · Innotron of Oregon, Inc. · Aug 1990
COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR
K852317 · Roche Diagnostic Systems, Inc. · Jun 1985
AMIKACIN ANALYTICAL TEST PACK ACA
K843211 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1984
EMIT QST AMIKACIN ASSAY
K840193 · Syva Co. · Mar 1984