FDA 510K for Mass Spectrometer System for Clinical Use for the Identification of Microorganisms
A Mass Spectrometer System for Clinical Use for the Identification of Microorganisms is a qualitative in vitro diagnostic device intended for the identification of microorganisms cultured from human specimens. The device is comprised of an ionization source, a mass analyzer, and a spectral database.
Intended Use of Mass Spectrometer System for Clinical Use for the Identification of Microorganisms
A mass spectrometer system for clinical use for the identification of microorganisms is a qualitative in vitro diagnostic device intended for the identification of microorganisms cultured from human specimens. The device is comprised of an ionization source, a mass analyzer, and a spectral database. The device is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and fungal infections.
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 Spectrometer System for Clinical Use for the Identification of Microorganisms
FDA 510K for Mass Spectrometer System for Clinical Use for the Identification of Microorganisms Device Code and Regulation Number
| S. No | Product Code | Device | Regulation Description | Regulation Number | Class |
| 1 | PEX | System, Mass Spectrometry, Maldi TOF, Microorganism Identification, Cultured Isolates | Mass Spectrometer System For Clinical Use For The Identification Of Microorganisms | 866.3361 | 2 |
System, Mass Spectrometry, Maldi TOF, Microorganism Identification, Cultured Isolates
Intended Use:
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.
Device description:
The device is based on matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF) mass spectrometry technology. The system consists of the following primary components:
- Ionization Source (MALDI): Cultured microbial colonies are applied to a target plate and overlaid with a chemical matrix. Upon exposure to a laser pulse, the matrix absorbs the laser energy, facilitating desorption and ionization of predominantly ribosomal proteins from the microorganism.
- Mass Analyzer (Time-of-Flight): The generated ions are accelerated in an electric field and separated according to their mass-to-charge (m/z) ratios based on their time of flight to the detector. Lighter ions reach the detector faster than heavier ions, producing a characteristic mass spectrum.
- Detector and Data Acquisition System: The detector captures the ion signals and converts them into a digital mass spectrum representing the protein profile of the microorganism.
- Spectral Database and Software: The acquired mass spectrum is automatically compared against a curated reference spectral database containing known bacterial and fungal organisms. Pattern-matching algorithms are used to determine the identity of the microorganism at the genus and/or species level, depending on database coverage.
The system provides rapid, automated, and reproducible identification of cultured microorganisms by analyzing unique protein “fingerprints.” Results are generated without the need for extensive biochemical testing, supporting timely clinical decision-making. The device does not determine antimicrobial susceptibility and is not intended for direct testing of clinical specimens without prior culture.
Performance Testing (Analytical) for Mass Spectrometer System for Clinical Use for the Identification of Microorganisms
- Precision/Reproducibility
- Linearity/assay reportable range
- Analytical specificity
- Accuracy
Clinical Testing:
No Guidance available for 510k submission