GENTAMICIN FLEX REAGENT CARTRIDGE

K962819 · Dade Intl., Inc. · LCD · Sep 13, 1996 · Clinical Toxicology

Device Facts

• Record ID: K962819
• Device Name: GENTAMICIN FLEX REAGENT CARTRIDGE
• Applicant: Dade Intl., Inc.
• Product Code: LCD · Clinical Toxicology
• Decision Date: Sep 13, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3450
• Device Class: Class 2

Intended Use

The GENT FLEX™ reagent cartridge used on the Dimension® clinical chemistry system is an in vitro diagnostic test intended to measure gentamicin, an aminoglycoside antibiotic drug, in human specimens. Measurements obtained by this assay are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.

Device Story

GENT FLEX™ reagent cartridge; used on Dimension® clinical chemistry system. Input: human serum or plasma samples. Principle: Particle Enhanced Turbidimetric Inhibition Immunoassay (PETINIA) using latex particle-gentamicin conjugate and gentamicin-specific monoclonal antibody. Output: quantitative gentamicin concentration (µg/mL). Used in clinical laboratory settings by trained personnel. Results assist clinicians in managing gentamicin therapy and identifying potential overdose. Benefits: automated, rapid monitoring of antibiotic levels to ensure therapeutic efficacy and patient safety.

Clinical Evidence

Method comparison study; 197 human serum/plasma samples tested on Dimension® system vs. Abbott AxSYM®. Results: slope 1.02, intercept -0.15, correlation coefficient 0.987, range 0.1-10.6 µg/mL.

Technological Characteristics

PETINIA (Particle Enhanced Turbidimetric Inhibition Immunoassay) technology. Reagents: latex particle-gentamicin conjugate, gentamicin-specific monoclonal antibody. Automated liquid reagent system. Designed for use on Dimension® clinical chemistry analyzers.

Indications for Use

Indicated for the measurement of gentamicin in human serum or plasma to diagnose gentamicin overdose and monitor therapeutic levels in patients undergoing aminoglycoside antibiotic treatment.

Regulatory Classification

Identification

A gentamicin test system is a device intended to measure gentamicin, an antibiotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.

Predicate Devices

• Abbott AxSYM® Gentamicin assay

Submission Summary (Full Text)

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DADE
K96289
DADE INTERNATIONAL
Chemistry Systems
P.O. Box 6101
Newark DE 19714

SEP 13 1996

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

## Gentamicin FLEX™ Reagent Cartridge

## Summary of Safety and Effectiveness

The GENT FLEX™ reagent cartridge used on the Dimension® clinical chemistry system is an *in vitro* diagnostic test intended to measure gentamicin, an aminoglycoside antibiotic drug, in human specimens. Measurements obtained by this assay are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.

The GENT method is based on Particle Enhanced Turbidimetric Inhibition Immunoassay (PETINIA) technique which uses a latex particle-gentamicin conjugate and gentamicin-specific monoclonal antibody.

The GENT FLEX™ reagent cartridge is substantially equivalent to the Abbott AxSYM® Gentamicin assay, which was cleared by the FDA through the 510(k) process. Both tests use liquid reagents in an automated system for the determination of gentamicin in human serum or plasma.

One hundred ninety-seven samples were tested with the GENT FLEX™ reagent cartridge on the Dimension® system and the Abbott Gentamicin assay on the Abbott AxSYM®, with the following results:

slope = 1.02
intercept = -0.15
correlation coefficient = 0.987
range of samples = 0.1-10.6 µg/mL

AxSYM® is a registered trademark of Abbott Laboratories, Abbott Park, IL 60064.

Carolyn K. George
Regulatory Affairs and
Compliance Manager

September 4, 1996

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