{"product_name":"MALDI Biotyper CA System","company_name":"Bruker","product_url":"https://www.bruker.com/products/microbiology-and-diagnostics/microbiology/identification/maldi-biotyper-ca-system.html","company_url":"https://www.bruker.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0632","summary":"The MALDI Biotyper CA System by Bruker is a mass spectrometry-based platform for rapid and accurate microbial identification in clinical settings.","description":"The MALDI Biotyper CA System utilizes Matrix-Assisted Laser Desorption Ionization Time-of-Flight (MALDI-TOF) mass spectrometry to identify microorganisms by analyzing their unique proteomic fingerprints. It offers a comprehensive FDA-cleared library covering over 480 species, including Gram-negative and Gram-positive bacteria, anaerobic bacteria, and yeasts. The system provides high accuracy comparable to 16S rRNA gene sequencing, with results available in minutes. It is designed for clinical microbiology laboratories to streamline workflows and enhance diagnostic efficiency. The system includes the microflex™ MALDI-TOF mass spectrometer, dedicated software, IVD-labeled reagents, and a 48-spot MALDI target. The MALDI Biotyper CA System is available for sale in the USA and Puerto Rico for prescription use only.","categories":["diagnostic Support","laboratory Testing","laboratory Equipment","Diagnostic","Clinical Microbiology","Laboratory Equipment"],"market_segment":["enterprise","smb"],"target_users":["clinicians","microbiologists","laboratory technicians"],"specialties":["Microbiology","Infectious Diseases","Clinical Diagnostics"],"regions_available":["United States","Puerto Rico"],"languages_supported":["English"],"pricing_model":"enterprise_quote","pricing_details":"Contact vendor for pricing information.","license":"commercial","company_offices":["United States","Germany","Switzerland","France","United Kingdom","Italy","Japan","China","India","Brazil"],"company_founding":"1960","deployment_model":["on_prem"],"os_platforms":["Windows"],"features":["Microbial identification using MALDI-TOF mass spectrometry","FDA-cleared library covering 488 microbial species","High-throughput capability with 96-sample capacity","Rapid identification with results in minutes","User-friendly software with automated result interpretation","Minimal sample preparation required","Cost-effective compared to traditional methods","Continuous operation with minimized maintenance","Integration with BD Phoenix and BD EpiCenter systems","Ready-to-use quality controls for precise identification"],"optional_modules":["MBT Filamentous Fungi Library","MBT IVD Library Extension","MBT Compass Reference Library"],"integrations":["BD Phoenix","BD EpiCenter"],"data_standards":["FDA-cleared library of 488 microbial species"],"api_available":"no","system_requirements":"Windows OS","compliance":["FDA 510(k) clearance","ISO 16140-6:2019","AOAC-OMA certification"],"certifications":["FDA 510(k) clearance","ISO 16140-6:2019","AOAC-OMA certification"],"security_features":["Audit logs","User authentication"],"privacy_features":["Data anonymization","Data minimization"],"data_residency":"US-only","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0632","slug":"maldi-biotyper-ca-system","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/maldi-biotyper-ca-system.json"}}