VANCOMYCIN FLEX REAGENT CARTRIDGE

K963267 · Dade Intl., Inc. · LEH · Sep 13, 1996 · Clinical Toxicology

Device Facts

• Record ID: K963267
• Device Name: VANCOMYCIN FLEX REAGENT CARTRIDGE
• Applicant: Dade Intl., Inc.
• Product Code: LEH · Clinical Toxicology
• Decision Date: Sep 13, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3950
• Device Class: Class 2

Intended Use

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

Device Story

VANC FLEX™ reagent cartridge; used on Dimension® clinical chemistry system. Input: human plasma or serum samples. Principle: Particle Enhanced Turbidimetric Inhibition Immunoassay (PETINIA) using latex particle-vancomycin conjugate and vancomycin-specific monoclonal antibody. Output: quantitative vancomycin concentration (µg/mL). Used in clinical laboratory settings by trained personnel. Results assist clinicians in therapeutic drug monitoring and overdose management.

Clinical Evidence

Bench testing comparing VANC FLEX™ on Dimension® system vs. aca® VANC test pack. Sample size: 231. Results: slope 0.95, intercept -0.33, correlation coefficient 0.987. Range: 0.1 - 49.8 µg/mL.

Technological Characteristics

Particle Enhanced Turbidimetric Inhibition Immunoassay (PETINIA). Reagents: latex particle-vancomycin conjugate, vancomycin-specific monoclonal antibody. Form factor: prepackaged reagent cartridge for automated clinical chemistry analyzer.

Indications for Use

Indicated for patients requiring monitoring of vancomycin levels in plasma and serum to guide antibiotic therapy and manage potential overdose.

Regulatory Classification

Identification

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

Predicate Devices

• aca® analytical test pack (K963267)

Submission Summary (Full Text)

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DADE
K963267
SEP 13 1996
DADE INTERNATIONAL
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

## Vancomycin FLEX™ Reagent Cartridge

## Summary of Safety and Effectiveness

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

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

The VANC FLEX™ reagent cartridge is substantially equivalent to the aca® analytical test pack, which was cleared by the FDA through the 510(k) process. Both tests used prepackaged reagents for the determination of vancomycin in human serum and plasma.

Two hundred thirty-one samples were tested with the VANC FLEX™ reagent cartridge on the Dimension® system and the aca® VANC test pack on the aca® discrete clinical analyzer, with the following results:

- slope = 0.95
- intercept = -0.33
- correlation coefficient = 0.987
- range of samples = 0.1 - 49.8 µg/mL

Carolyn K. George
Regulatory Affairs and
Compliance Manager

September 4, 1996
Date

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