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The Abbott m2000 system is intended for in vitro diagnostic use in performing FDA cleared and approved nucleic acid testing in clinical laboratories. It comprises the Abbott m2000sp and the Abbott m2000rt instruments. The Abbott m2000sp is an automated system for performing sample preparation for nucleic acid testing. The Abbott m2000rt is an automated system for performing fluorescence-based PCR to provide quantitative and qualitative detection of nucleic acid sequences.

The Abbott m2000 System is an instrument platform that automates steps to perform nucleic acid amplification assays from sample processing through amplification, detection, and data reduction. The Abbott m2000 System comprises the m2000sp and m2000rt instruments, which are operated with separate System Control Center (SCC) workstations. Each instrument contains an independent software application; one for the m2000sp and a second for the m2000rt. The m2000sp instrument is a floor standing, automated sample preparation system. The three main components of the m2000sp are the: Instrument, Cabinet, System Control Center (SCC). The m2000rt instrument is a real-time PCR thermal cycler/reader instrument system. The two main components of the m2000rt are the: Instrument, System Control Center (SCC). The Abbott m2000 System software processes sample preparation and amplification/detection protocols based on pre-determined, assay-specific parameters that are contained in individual assay application specification files that are installed on the SCC. The Abbott m2000sp reads and processes bar coded primary sample tubes and processes up to 96 specimens, controls, and calibrators in batch mode. The m2000 System is capable of processing samples from various matrices, depending on the specific assay application, including plasma, serum, endocervical swabs, urethral swabs, vaginal swabs, and urine. At the completion of the automated sample preparation protocol, the operator seals and manually transfers the PCR plate to the Abbott m2000rt for nucleic acid detection. Bar code and m2000sp data is transferred to the m2000rt electronically.