Table of Contents
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1.
Introduction
1.A. Maxwell
®
CSC Instrument Purifi cation Procedure
The Maxwell
®
tion for a range of clinical sample types. The Maxwell
only. The purifi cation methods use sample lysis and binding to paramagnetic particles as the primary
separation principle. Up to 16 samples can be prepared in a single run.
The automated steps performed by the Maxwell
•
Sample lysis in the presence of a specially formulated Lysis Buff er
•
Binding of nucleic acids to paramagnetic particles
•
Washing of the bound target molecules away from other cellular components
•
Elution of the product
The instrument is controlled by a graphical user interface running on a tablet PC. The Maxwell
Instrument has the ability to record and report sample tracking and method run data. A bar code reader is
supplied with the Maxwell
information for samples and reagents. The Maxwell
for instrument operations, and the reports can be printed and exported to an administrator-specifi ed
storage location or a USB drive for transfer to a separate computer. To start a run the user scans the bar
code of the reagent kit to be processed; this selects the appropriate protocol to be run. After entering the
sample tracking information, the user follows the recommended protocol for the Maxwell
prepares the deck tray of the instrument as instructed. The cartridges are placed into the instrument, and
the method is automatically run. Use of the instrument does not require any special training. However,
training is available as part of Operational Qualifi cation, which is off ered separately (see Section 9.B).
1.B. Product Intended Use
The Maxwell
in vitro diagnostic (IVD) medical device to perform automated isolation of nucleic acids. The nucleic acid
isolated using the Maxwell
amplifi cation methods. These methods include a variety of polymerase chain reaction (PCR) tests for human
in vitro diagnostic purposes.
The Maxwell
®
Maxwell
®
CSC Instrument is intended for professional use only. Diagnostic results obtained using the
nucleic acids purifi ed with this system must be interpreted in conjunction with other clinical or laboratory
data.
4
Promega Corpora on · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · 608-274-4330 · Fax 608-277-2516
TM424 · Revised 2/15
Clinical Sample Concentrator (CSC) Instrument
®
CSC Instrument and is used for starting method runs and capturing bar code
®
CSC Instrument is intended for use, in combination with Maxwell
®
CSC Instrument is suitable for direct downstream analysis by standard
CSC Instrument is not intended for use as part of a specifi c in vitro diagnostic test. The
(a)
provides automated nucleic acid purifi ca-
®
CSC Instrument is intended for professional use
®
CSC Instrument include:
®
CSC Instrument provides reports of the data gathered
®
CSC
®
CSC kit and
®
CSC reagent kits, as an
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