2. General
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2. General
2.1 Intended Use / Introduction
The labtech.com LT-4500 instrument is a 96-well absorbance reader for the
measurement of light absorbance (optical density) of liquid media. The instrument
is intended to be used primarily in in-vitro diagnostic analysis of samples from the
human body to obtain information on physiological and pathological states.
For applications in human medicine, only the LT-com software is intended for the
use with the instrument. Software and instrument have been validated for
measurement and for the evaluation of qualitative and quantitative Enzyme-linked
Immunosorbent Assays (ELISA) according to the scheduled diagnostic
parameters and instrument specifications; they are therefore intended for
professional use in in-vitro diagnostics.
Note
If the LT-4500 absorbance reader or the LT-com software is modified in
any way, the warranty will no longer be valid and the instrument will lose
regulatory conformity.
Note
The operating authority must use only CE-labeled test kits for clinical
diagnostic applications. The operating authority must assure that the
combination of a particular CE-labeled test kit used with the CE-labeled
LT-4500 absorbance reader and its options have been validated to meet
the IVD directive 98/79/EC or other relevant national or local regulations.
If the LT-4500 absorbance reader is used differently from the ‘Intended Use’
mentioned above or if it is used with other software than LT-com, the instrument
is no longer IVD conform and the user is responsible for the respective use and
the necessary validation.
Note
Results obtained using the LT-4500 are influenced by the proper use of
the instrument and microplates, according to the instructions given in
this document, as well as the liquid compounds used (reagents,
chemistry). The instructions for use, storage, and applications involving
samples or reagents must be followed strictly. Results must therefore be
interpreted carefully.
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General