5
Promega Maxwell
®
CSC 48 Instrument | TM623 | Revised 6/20
1.2 Product Intended Use
The Maxwell
®
CSC 48 Instrument is intended for use, in combination with Maxwell
®
CSC
reagent kits, as an in vitro diagnostic (IVD) medical device to perform automated isolation of
nucleic acids. The nucleic acid isolated using the Maxwell
®
CSC 48 Instrument is suitable for
direct downstream analysis by standard amplification methods. These methods include a variety
of polymerase chain reaction (PCR) tests for human in vitro diagnostic purposes. The Maxwell
®
CSC 48 Instrument is not intended for use as part of a specific in vitro diagnostic test. The
Maxwell
®
CSC 48 Instrument is intended for professional use only. Diagnostic results obtained
using the nucleic acids purified with this system must be interpreted in conjunction with other
clinical or laboratory data.
1.3 Product Use Limitations
The Maxwell
®
CSC 48 Instrument is only available in certain countries. When used in IVD mode,
the Maxwell
®
CSC 48 Instrument is not intended for use with reagent kits other than Maxwell
®
CSC reagent kits or with samples other than those defined within the intended use and product
limitations of the specific Maxwell
®
CSC reagent kit being used. The user is responsible for
establishing performance characteristics necessary for downstream diagnostic applications.
Appropriate controls must be included in any downstream diagnostic applications using nucleic
acids purified with the Maxwell
®
CSC 48 Instrument.
1.4 Maxwell
®
CSC 48 Instrument Features
• Easy-to-use and easy-to-maintain system operation
• Standardized sample preparation workflow
• System controlled via Tablet PC
• Reporting functionality
• Preprogrammed methods for nucleic acid purification
• Included Bar Code Reader
• UV lamp to aid in decontamination of instrument
• Integrated Vision system for confirming proper deck tray preparation
• Integral USB hub for easy connection to accessory devices
• Comprehensive technical support
Introduction
