TOBRAMYCIN FLEX REAGENT CARTRIDGE

K962818 · Dade Intl., Inc. · LCR · Sep 13, 1996 · Clinical Toxicology

Device Facts

• Record ID: K962818
• Device Name: TOBRAMYCIN FLEX REAGENT CARTRIDGE
• Applicant: Dade Intl., Inc.
• Product Code: LCR · Clinical Toxicology
• Decision Date: Sep 13, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3900
• Device Class: Class 2

Intended Use

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

Device Story

In vitro diagnostic test; measures tobramycin levels in human plasma/serum; utilizes Particle Enhanced Turbidimetric Inhibition Immunoassay (PETINIA) technique; employs latex particle-tobramycin conjugate and tobramycin-specific monoclonal antibody; operated on Dimension® clinical chemistry system; provides quantitative results for clinicians to manage antibiotic therapy and assess potential overdose.

Clinical Evidence

Bench testing comparing 141 samples using TOBR FLEX™ on Dimension® system versus aca® TOBRA test pack on aca® analyzer. Results: slope 0.99, intercept 0.10, correlation coefficient 0.989, range 0-12 µg/mL.

Technological Characteristics

Particle Enhanced Turbidimetric Inhibition Immunoassay (PETINIA); uses latex particle-tobramycin conjugate and monoclonal antibody; prepackaged reagent cartridge format; designed for use on Dimension® clinical chemistry system.

Indications for Use

Indicated for patients requiring monitoring of tobramycin levels to ensure appropriate therapy or diagnosis of tobramycin overdose using plasma or serum samples.

Regulatory Classification

Identification

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

Predicate Devices

• aca® tobramycin analytical test pack

Submission Summary (Full Text)

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DADE
K962818
DADE INTERNATIONAL
SEP 13 1996
Chemistry Systems
P.O. Box 6101
Newark, DE 19714

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

## Tobramycin FLEX™ Reagent Cartridge

### Summary of Safety and Effectiveness

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

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

The TOBR FLEX™ reagent cartridge is substantially equivalent to the aca® tobramycin analytical test pack, which was cleared by the FDA via the 510(k) process. Both tests use prepackaged reagents for the determination of tobramycin in human serum or plasma.

One hundred forty-one samples were tested with the TOBR FLEX™ reagent cartridge on the Dimension® system and the aca® TOBRA test pack on the aca® discrete clinical analyzer, with the following results:

slope = 0.99
intercept = 0.10
correlation coefficient = 0.989
range of samples = 0-12 µg/mL

Carolyn K. George
Regulatory Affairs and
Compliance Manager

September 4, 1996
Date

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