Promega Maxwell 16, Operating Manual

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Promega Corporation · 2800 Woods Hollow Road · Madison, WI 53711-5399 USA · Toll Free in USA 800-356-9526 · Phone 608-274-4330 · Fax 608-277-2516 · www.promega.com
Printed in USA. Part# TM300
2/08 Page 3
I. Introduction
I.A. Intended Use of the Maxwell
®
16 System (Cat.# AS2050 and AS1015)
The Maxwell
®
16 System, which consists of the Maxwell
®
16 Clinical Instrument
(a)
(Cat.# AS2050) and the
Maxwell
®
16 Blood DNA Purification Kit
(b,c)
(Cat.# AS1015), is used to perform automated isolation of
DNA from human whole blood or buffy coat samples. Samples collected in blood collection tubes treated
with EDTA, heparin or citrate can be used with the Maxwell
®
16 System. The nucleic acid isolation
methodology used by the Maxwell
®
16 System produces DNA 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
®
16 System is not intended for use as part of a
specific in vitro diagnostic test.
The Maxwell
®
16 Clinical Instrument displays the CE conformity marking to identify it as fulfilling the
requirements of the Low Voltage Directive, Electromagnetic Compatibility Directive, and the In Vitro
Diagnostic Medical Device Directive and associated harmonized standards.
The Maxwell
®
16 System is intended for professional use only. Diagnostic results obtained using DNA
purified with this system must be interpreted in conjunction with other clinical or laboratory data.
Product Use Limitations
The Maxwell
®
16 System is not intended for use with tissue samples or samples from body fluids other
than blood. It is not intended for use with non-human samples or for purification of RNA.
The Maxwell
®
16 System performance has been evaluated by isolating DNA from 300µl whole blood
samples, or 250µl buffy coat samples, obtained from healthy individuals with a white blood cell count
ranging from 4.2 × 10
6
to 1.2 × 10
7
.
The user is responsible for establishing performance characteristics necessary for downstream
diagnostic applications. Appropriate controls must be included in any downstream diagnostic
applications using DNA purified using the Maxwell
®
16 System.
Compliance with EU Directive 98/79/EC on in vitro diagnostic medical devices has been demonstrated
for, and only applies to, use of the Maxwell
®
16 Instrument (Cat.# AS2050) in the clinical mode with the
Maxwell
®
16 Blood DNA Purification Kit (Cat.# AS1015).
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