for 510(k) clearance - Applied Biosystems · Clinical trial for 510(k) clearance The 3500 and...

Clinical trial for 510(k) clearance

The 3500 and 3500xL Dx Genetic Analyzers CS2

CAPILLARY ELECTROPHORESIS

CO19459 Molokai- Instrument prelaunch brochure.indd 1 7/14/11 4:22 PM

The Applied Biosystems® capillary electrophoresis platforms are the industry standard, providing the most reliable, efficient, and widely published technology for DNA sequence analysis. Sequence-based analysis methods play an increasingly important contribution in the evolution of molecular medicine.

A clinical trial to evaluate the 3500 Dx Series Genetic Analyzers, SeCore® HLA typing kits, and uTYPE® Dx analysis software began in March 2011 in US-based sites. By completing clinical trials and pursuing 510(k) clearance of the 3500xL Dx Genetic Analyzer and SeCore® kits, Life Technologies will demonstrate the utility of capillary electrophoresis Genetic Analyzer and sequence-based assays as powerful tools in the molecular diagnostic laboratory. We anticipate filing for 510(k) clearance in the third quarter of 2011.

The Applied Biosystems® 3500 Dx Series Genetic Analyzers already received the CE-IVD mark in 2009 and are available for sale in selected countries in Europe and Asia.

Find out more about the trials at www.clinicaltrials.gov, clinical trial number NCT01285427.

The next step in molecular medicine3500 Dx Genetic Analyzers


Improved instrument design delivers maximum performance

The 3500 Dx Series is setting a new standard in capillary electrophoresis—integrat-ing a number of platform improvements for the optical and thermal subsystems, and pioneering an innovative con-sumables system approach. The system features an advanced long-life solid-state laser, which reduces the physical and environmental footprint of the system as well as the cost of ownership. The 3500 Dx System operates using standard power outlets, facilitating plug-in-and-go operation. And the laser generates less heat than previous designs, eliminating the need for heat-ducting infrastruc-ture in the laboratory. Moreover, these features minimize the overall dimensions of the instrument, providing maximum performance while occupying minimal laboratory space.

Plate base and retainer Polymer Sequencing standard


Incorporating well-designed and easily deployed consumables, the 3500 Dx Series Genetic Analyzers were designed to simplify instrument operation and streamline critical administrative and QC procedures and reports. The result? A clearer path between your ideas and your clinical outcomes.

• Reduced hands-on time—just snap in the capillary array, polymer pouch, and pre filled buffer containers and go

• Traceable usage—RFID tags allow viewing, tracking, and reporting of critical information about reagents and consumables (usage, lot number, part number, expiration date, and on-instrument lifetime)

Easy-to-install, trackable, auditable consumables

Capillary array Cathode buffer container Anode buffer container


Redesigned from the ground up, the 3500 Dx Series Data Collection Software makes this the easiest capillary elec-trophoresis system to use—start your run in as few as three clicks. With the ability to collect data in IVD (diagnostic) mode or RUO mode, the 3500 Dx Series Data Collection Software offers your lab the flexibility for diverse workflows.

• Simplified functionality—built-in quality control and software-controlled functions such as plate setup, data collection, and analysis for easy operation

• Intuitive dashboard design—clear buttons, easy-to-read displays for consumables monitoring, handy maintenance scheduling calendar

• Data quality evaluation in real time—immediate access to base-called or size-called data allows you to make decisions without transferring to external analysis software

• Preconfigured plate templates—for controlled and efficient run setup

User-friendly software for accurate, secure data collection

3500xL Dx Genetic Analyzer Data Collection modes.

Maintenance scheduling calendarRun monitoringPlate setup


POCKET


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For Investigational Use Only. The performance characteristics of this product have not been established.© 2011 Life Technologies Corporation. All rights reserved. The trademarks mentioned herein are the property of Life Technologies Corporation or their respective owners. Printed in the USA. CO19459 0711


for 510(k) clearance - Applied Biosystems · Clinical trial for 510(k) clearance The 3500 and...

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