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The MALDI Biotyper CA System is a mass spectrometer systems using matrix-assisted laser desorption/ionization - time of flight (MALDI-TOF) for the identification of microorganisms cultured from human specimens. The MALDI Biotyper CA System is a qualitative in vitro diagnostic device indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and yeast infections.

The MBT-CA System is a mass spectrometer system using matrix-assisted laser desorption/ionization - time of flight (MALDI-TOF) for the identification of microorganisms cultured from human specimens. The system uses a different methodology for organism identification based on unique protein patterns of the microorganisms obtained from mass spectrometry. The test organism's spectrum (a pattern of mass peaks) is compared with a reference spectra library (database). Using biostatistical analysis, a probability ranking of the organism identification is generated. The probability ranking is represented as a log(score) between 0.00 and 3.00. Organism identification is reported with high confidence if the log(score) is ≥2.00. An organism identification is reported with low confidence if the log(score) is between 1.70 and <2.00.

VITEK® MS is a mass spectrometry system using matrix-assisted laser desorption/ionization – time of flight mass spectrometry (MALDI-TOF MS) for the identification of microorganisms cultured from human specimens. The VITEK® MS is a qualitative in vitro diagnostic device in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial, yeast and mould infections.

VITEK® MS is mass spectrometry system using matrix-assisted laser desorption/ionization-time of flight mass spectrometry (MALDI-TOF MS) for the identification of microorganisms cultured from human specimens. The VITEK® MS is a qualitative in vitro diagnostic device indicated for use in coniunction with other clinical and laboratory findings to aid in the diagnosis of bacterial, yeast and mould infections. The VITEK® MS is intended for laboratory use by professional users who are trained in microbiology and good laboratory practices. This 510(k) is an update to the VITEK® MS (Mass Spectrometry) clinical knowledge base (KB v3.0.0) for the purposes of identifying Mycobacterium, Nocardia, and mould isolates. As the VITEK® MS KB v3.0.0 update includes new indications for use on the VITEK® MS system, new clinical data was required to establish safety and effectiveness. To account for the detection of higher mass peaks, relevant for some moulds and Mycobacterium, the VITEK® MS acquisition station software was optimized (in v1.5.0) . Microorqanism identifications are are made via matrix-assisted laser desorption/ionization - time of flight mass spectrometry (MALDI-TOF MS) technology, which includes the three basic principles of ionization, separation, and detection. Depending on the isolate culture, the analyte sample may be directly spotted to a target slide, or for Mycobacterium, Nocardia and mould it must be processed/inactivated before adding to the target slide. Once spotted to the target slide, a matrix is added for the purpose of easy sublimation and strong absorbance in the laser wavelength employed by the instrument. The slide is then loaded onto the instrument, where a laser targets the sample spot and pulses the isolate spot, resulting in vibrational excitation of matrix and analyte molecules. The matrix transfer protons to the analyte resulting in a positive charge. The ionized molecules are then accelerated in an electromagnetic field and a grid electrode in the ionization chamber. The velocity of the molecules depends on the mass-to-charge (m/z) ratio of the analyte, with heavier molecules having a higher moment of inertia resulting in a lower velocity. The time of flight is measured precisely by the ions arrival at a particle detector. Based on the time of flight, the m/z ratio of each particle can be determined, and a mass spectrum of the analyte sample mixture is generated. The mass spectrum displays results as a series of peaks (spectrum) which correspond to the ionized proteins derived from the analyte sample. The mass spectra are sufficiently distinctive to allow taxonomic characterization at the genus and species.

The Bruker Daltonics, Inc. MALDI Biotyper CA System is a mass spectrometer system using matrix-assisted laser desorption/ionization – time-of-flight (MALDI-TOF) for the identification of microorganisms cultured from human specimens. The MALDI Biotyper CA System is a qualitative in vitro diagnostic device indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and yeast infections.

The Bruker Daltonics, Inc. MALDI Biotyper CA System is a mass spectrometer system using matrix-assisted laser desorption/ionization – time-of-flight (MALDI-TOF) for the identification of microorganisms cultured from human specimens. The system measures the time (in the nanosecond range) between pulsed acceleration and the corresponding detector signal, the speed is converted into an exact molecular mass. The mass-to-charge ratio of an ion is proportional to the square of its drift time. Highly abundant microbial proteins (mainly ribosomal proteins) result in a mass spectrum with characteristic mass and intensity distribution. It is specific for many bacteria and is interpreted as a molecular fingerprint to identify the test organism.

VITEK MS is a mass spectrometer system using matrix-assisted laser desorption/ionization time to flight (MALDI-TOF) for the identification of microorganisms cultured from human specimens. The VITEK®MS is a qualitative in vitro diagnostic device indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and yeast infections.

The VITEK® MS v2.0 system is a system consisting of kit reagents (VITEK MS-CHCA, VITEK MS-FA), VITEK MS-DS target slides, VITEK® MS Prep Station, Knowledge Base, software, and the VITEK®MS (original equipment manufacturer (OEM)-labeled Shimadzu AXIMA® Assurance mass spectrometer). The VITEK® MS v2.0 system includes an OEM-labeled Shimadzu AXIMA® Assurance mass spectrometer linked to a reference database, referred to as Knowledge Base. Matrix assisted laser desorption ionization (MALDI) is the process used to ionize a sample in to the gas phase. A pulsed laser beam is directed on to the sample. Energy from the laser beam desorbs and ionizes the sample. Extraction plates provide high-voltage electrical fields to accelerate the ionized particles upwards through the time-of-flight (TOF) vacuum tube. An ion lens focuses the ions. Deflector plates steer the ions on a path towards the linear detector at the flight-tube. An ion gate blanks out low mass ions (for example, derived from the matrix). The detector detects the ions directly from the sample (lower-molecular weight ions followed by highermolecular weight ions). Ions hitting the detector cause an electrical signal which is recorded. The recorded signal is processed by the software and presented as a spectrum of intensity versus mass, in Daltons (Da). During target ionization, mass spectra within a range of 2,000-20,000 Daltons are recorded in linear positive mode at a laser frequency of 50 Hz. For each interrogation, laser shots at different positions within the target well produce up to 100 mass profiles that are summed into a single, raw mass spectrum. The spectrum is then processed by baseline correction, de-noising, and peak detection to identify well-defined peaks. The list of these significant peaks is subjected to a proprietary process called "mass binning". The processed (binned) data are used to query the Knowledge Base to determine the unknown's taxonomic identity. These results are then provided in the form of a single, species-level (and sometimes subspecies-level) identification, a split (low discrimination) identification with up to four species-level alternatives displayed, or no identification.