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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.

Here's an analysis of the provided text to extract the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a formal table format with numerical targets. However, based on the performance data presented, the implicit acceptance criteria for identification confidence (log(score) ≥ 2.00) are assessed. The reported performance for "Overall Isolate Performance" (Table 6) shows the aggregate performance across all claims.

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The Bruker Daltonics, Inc MALDI Biotyper CA System is a qualitative in vitro diagnostic mass spectrometer system for the identification of Gram-negative bacterial colonies cultured from human specimens using matrix-assisted laser desorption/ ionization - time of flight (MALDI-TOF) mass spectrometry technology.

The MALDI Biotyper CA System is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of Gram negative bacterial infections.

The MBT-CA 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

The provided text describes the acceptance criteria and a detailed study for the MALDI Biotyper CA System, a mass spectrometer used for identifying Gram-negative bacterial colonies.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied throughout the performance studies, aiming for high correct identification rates and low false identification/no identification rates for organisms within the claim, and "No Identification" for organisms outside the claim.

• Average log(score): All tested organisms in DT+Ext method showed high average log(scores) well above the 2.0 threshold (ranging from 2.138 to 2.587), with low standard deviations.
• Conclusion: Study confirms repeatability and precision independent of system operators, microflex instruments, target lots, matrix lots, and BTS lots. |
  | Limit of Detection | Ability to correctly identify organisms (log(score) ≥2.00) within a specified dynamic range of cell concentrations for both Direct Transfer (DT) and Extraction (Ext) methods. | - Dynamic Range (DT): Lower limit: 6.3x10³-1.4x10⁴ cells/µL, Upper limit: 1.4x10⁶- ≥ 6.5x10⁷ cells/µL.
• Dynamic Range (Ext): Lower limit: 9.0x10³-1.3x10⁵ cells/µL, Upper limit: 1.1x10⁷- ≥ 6.9x10⁷ cells/µL.
• Conclusion: The device successfully identified organisms within these estimated dynamic ranges. |
  | Specificity | - Organisms not included in the reference library should be reported as "No Identification" (Phase 1).
• Closely related species not in the reference library should not produce incorrect identifications. (Phase 1)
• Closely related claimed species should be uniquely identified (Phase 2). | - Phase 1 (Non-claimed organisms): 100% (2/2 for all tested strains) of Anaerobes, Mycobacteria, Gram-Negative (not claimed), Gram-Positive, and Yeast organisms returned "No Identification" with zero false identifications.
• Phase 2 (Closely related claimed species): 100% (2/2 for all tested strains) of Burkholderia cepacia, B. multivorans, and B. gladioli were correctly identified with zero false identifications.
• Conclusion: High confidence in specificity, demonstrating non-claimed organisms are not falsely identified and closely related species are differentiated. |
  | Mixed Culture | No false identifications when a mixed culture is analyzed, even with varying concentrations of target and non-target organisms. (Users are still instructed to test single isolated colonies). | - Performance: 0/32 false identifications across all tested conditions (100% target, 75% target/25% non-target, 50% target/50% non-target, 25% target/75% non-target).
• Conclusion: No false results were obtained, and the impact on final test results is "greatly reduced" compared to biochemical methods. |
  | Media and Colony Stability | - Acceptability of specified culture media (TSA, CBA, MAC, CHOC).
• Colony stability for up to 12 hours post-incubation at room temperature. | - Media Acceptability: All four media (TSA, CBA, MAC, CHOC) showed high identification rates (263/288 to 288/288) with 0/288 false identifications for both DT and Ext methods.
• Colony Stability: Confirmed stability for up to 12 hours post-incubation. |
  | Influence of Agar Media | - Agar media alone should not generate mass spectra leading to false identification (100% "No ID" for agar alone).
• Agar media should not interfere with MBT-CA performance or organism identification when present with the isolate. | - Agar Alone: 100% (12/12) of agar only replicates resulted in "No ID".
• Target + Agar: 100% (10/12 to 12/12, depending on media) of target organism + agar replicates showed 0% false identifications.
• Conclusion: Media do not interfere with performance or identification and do not generate false identifications on their own. |
  | Organism Stability prior to MBT-CA Analysis | - Isolate stability on the target plate (prior to matrix overlay) for up to 60 minutes via DT and Ext.
• Stability of extracted material (prior to target plate inoculation) for up to 24 hours at room temperature. | - Isolate on Target (DT/Ext): 100% correct identification (24/24 or 6/6) at all time points up to 120 minutes for DT and 60 minutes for Ext, with 0 false identifications.
• Extracted Material Stability: 100% correct identification (24/24) for up to 24 hours when stored at room temperature, with 0 false identifications.
• Conclusion: Samples are stable on the target plate for up to 60 minutes, and extracts are stable for up to 24 hours at room temperature. |
  | Sample Stability overlaid with Matrix | - Stability of test organisms on the spotted target plate after matrix addition for up to 24 hours across various temperature and humidity conditions.
• Matrix alone should not interfere or influence identification (should result in "No Peaks Found"). | - Organism Stability: Mostly 100% correct identification across various temperature/humidity conditions and time points up to 24 hours. A few instances showed 23/24 or 18/24 correct identifications at 8 hours under specific stressed conditions, but the 24-hour mark returned to 24/24, suggesting good overall stability.
• Matrix Alone: 100% "No Peaks Found" for matrix alone across all conditions and time points.
• Conclusion: Inoculated test organisms overlaid with matrix are stable for up to 24 hours at room temperature, and matrix alone does not interfere. |
  | Bacterial Test Standard (BTS) Stability | - BTS stability for 3 weeks at 37±2ºC (accelerated/shipping).
• BTS stability for 12 months at

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