Clinical trial for 510(k) clearance

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Erick Dickerson
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1 CAPILLARY ELECTROPHORESIS Clinical trial for 510(k) clearance The 3500 and 3500xL Dx Genetic Analyzers CS2 CO19459 Molokai- Instrument prelaunch brochure.indd 1

2 The next step in molecular medicine 3500 Dx Genetic Analyzers 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 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 clinical trial number NCT CO19459 Molokai- Instrument prelaunch brochure.indd 2

3 Improved instrument design delivers maximum performance The 3500 Dx Series is setting a new standard in capillary electrophoresis integrating a number of platform improvements for the optical and thermal subsystems, and pioneering an innovative consumables 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 infrastructure 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 CO19459 Molokai- Instrument prelaunch brochure.indd 3

4 Easy-to-install, trackable, auditable consumables 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) Capillary array Cathode buffer container Anode buffer container CO19459 Molokai- Instrument prelaunch brochure.indd 4

5 User-friendly software for accurate, secure data collection Redesigned from the ground up, the 3500 Dx Series Data Collection Software makes this the easiest capillary electrophoresis 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 3500xL Dx Genetic Analyzer Data Collection modes. Plate setup Run monitoring Maintenance scheduling calendar CO19459 Molokai- Instrument prelaunch brochure.indd 5

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7 POCKET CO19459 Molokai- Instrument prelaunch brochure.indd 7 7/14/11 4:23 PM

8 For Investigational Use Only. The performance characteristics of this product have not been established 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. CO lifetechnologies.com CO19459 Molokai- Instrument prelaunch brochure.indd 8 7/14/11 4:23 PM

Applied Biosystems 3500/3500xL Genetic Analyzer

QUICK REFERENCE Applied Biosystems 3500/3500xL Genetic Analyzer with 3500 Series Data Collection Software 3 Catalog Number 4405186, 4405187 Pub. No. 100026299 Rev. A Note: For safety and biohazard guidelines,