FDA 510K for Mass Spectrometry, Microorganism Identification
In the context of blood cultures, Mass Spectrometry, particularly the technique known as Matrix-Assisted Laser Desorption Ionization-Time Of Flight (MALDI-TOF) Mass Spectrometry, is a highly effective method for rapidly identifying microorganisms directly from a positive blood culture, allowing for quicker diagnosis and treatment of bloodstream infections compared to traditional culture methods; essentially, it analyzes the unique protein profile of a microbe to identify its species by comparing it to a database of known organisms.
Intended Use of Mass Spectrometry, Microorganism Identification
Blood culture processing device that includes associated reagents that are intended to concentrate and purify microbial cells from blood culture samples identified as positive by a continuous monitoring blood culture system with organisms subsequently identified by spectrometry.
For a detailed proposal with a Statement of Work, please complete the Request for Quote (RFQ) form provided separately for FDA 510(k) and IVDR CE Marking for Mass Spectrometry, Microorganism Identification
FDA 510K for Mass Spectrometry, Microorganism Identification Device Code and Regulation Number
Mass Spectrometry, Microorganism Identification
Intended use:
It is intended for use by trained healthcare professionals in clinical laboratories in conjunction with other clinical and laboratory findings, including Gram staining, to aid in the diagnosis of bloodstream infections.
Device description:
Mass Spectrometry, particularly MALDI-TOF (Matrix-Assisted Laser Desorption/Ionization Time-of-Flight), is widely used for rapid microorganism identification, including blood culture. This technology is to analyze the proteomic fingerprints of microorganisms, providing species-level identification in a matter of minutes. The Kit is often used for preparing microorganisms from positive blood cultures for MALDI-TOF analysis. This technique offers significant advantages in terms of speed, accuracy, and cost-effectiveness, dramatically reducing turnaround times compared to traditional methods. It also eliminates the need for multiple biochemical tests, though accurate results depend on proper sample preparation and a comprehensive reference database. Overall, MALDI-TOF MS has revolutionized clinical microbiology by enabling quick, precise pathogen identification directly from blood cultures.
Mass Spectrometry, MALDI TOF, Microorganism Identification, Cultured Isolates (QBN)
Intended use:
It is intended for use by trained healthcare professionals in clinical laboratories in conjunction with other clinical and laboratory findings, including Gram staining, to aid in the diagnosis of bloodstream infections.
Device description:
The System is a mass spectrometer system using matrix-assisted laser desorption/ionization – time of flight (MALDI-TOF) for the identification and differentiation of microorganisms cultured from human specimens. The 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 fungal infection
Performance Testing (Analytical) for Mass Spectrometry, Microorganism Identification
- Precision (Reproducibility and Repeatability)
- Assay reportable range
- Accuracy
- Traceability, Stability, Expected Values (Controls, Calibrators, or Methods)
- Sensitivity and Specificity
- Limit of Detection (LoD), Limit of Quantitation (LoQ), and Limit of Blank (LoB)
- stability
- Method comparison
Clinical Testing:
No Guidance available for 510k submission