System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
The MALDI-TOF Mass Spectrometry System for Microorganism Identification of Cultured Isolates is a microbiology device using matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF) mass spectrometry to identify microorganisms from cultured isolates by generating and analyzing protein mass spectra unique to each species. It falls under the Microbiology medical specialty and is classified as a Class 2 device under regulation 866.3361, requiring 510(k) premarket notification. MALDI-TOF systems have transformed clinical microbiology by enabling rapid, accurate, and cost-effective organism identification. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PEX
- Device Class
- FDA class 2
- Regulation Number
- 866.3361
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
Definition
A mass spectrometer system using matrix-assisted laser desorption/ ionization - time of flight (MALDI-TOF) for the identification of microorganisms cultured from human specimens.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K163536 | MALDI Biotyper CA (MBT-CA) System, MBT smart CA System | Jul 26, 2017 | Substantially Equivalent | Bruker Daltonik GmbH |
| K162950 | VITEK MS | Jul 22, 2017 | Substantially Equivalent | bioMerieux, Inc. |
| K142677 | MALDI Biotyper CA System | Mar 27, 2015 | Substantially Equivalent | Bruker Daltonics, Inc. |
| K130831 | MALDI BIOTYPER CA (MBT-CA) SYSTEM | Nov 21, 2013 | Substantially Equivalent | Bruker Daltonics, Inc. |
| DEN130013 | VITEK MS | Aug 21, 2013 | Unknown | bioMerieux, Inc. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.