{"product_name":"APAS Independence","company_name":"Clever Culture Systems","product_url":"https://www.cleverculturesystems.com/technology/intelligent-automation/apas-independence","company_url":"https://www.cleverculturesystems.com","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0556","summary":"APAS Independence is an automated system that uses AI to analyze and interpret microbial growth on culture plates, enhancing efficiency in microbiology laboratories.","description":"APAS Independence is a stand-alone instrument developed by Clever Culture Systems that automates the imaging, interpretation, and reporting of microbial growth on culture plates. It utilizes advanced imaging and machine learning algorithms to process up to 200 culture plates per hour, integrating seamlessly into existing laboratory workflows without the need for proprietary media or specific incubators. The system is FDA-cleared and has achieved regulatory clearances in the US, Europe, and Australia, offering modules for applications such as urine screening, infection control testing, and antimicrobial susceptibility testing. It is distributed exclusively in the United States by Thermo Fisher Scientific.","categories":["clinical Care","administrative Operations","diagnostic Support","laboratory Automation","laboratory Testing","Clinical","Administrative","Diagnostic","Laboratory Automation","Microbiology"],"market_segment":["enterprise","smb"],"target_users":["microbiologists","clinical laboratory technicians","pharmaceutical quality control personnel"],"specialties":["Microbiology","Clinical Diagnostics","Pharmaceutical Manufacturing"],"regions_available":["United States","Europe","Australia"],"languages_supported":["English"],"pricing_model":"enterprise_quote","pricing_details":"Contact vendor for pricing information.","license":"commercial","company_offices":["Australia","United States","Sweden","United Kingdom","Germany"],"company_founding":"2004","deployment_model":["on_prem"],"os_platforms":["Windows","Linux"],"features":["Automated imaging, interpretation, and reporting of microbial growth on culture plates","Processes up to 200 culture plates per hour","Supports various culture media types and brands","Flexible integration with Laboratory Information Management Systems (LIMS)","APAS Web User Interface for remote access to culture plate images and reports","Full audit trail of all interactions with the instrument","Automated separation and flagging of plates with mould or spreading colonies for review","Digital microbiology workflow enhancing consistency of results","Minimal user interaction with intuitive user interface","Supports both settle (90mm) and contact (55mm) plates"],"optional_modules":["MRSA Analysis Module","Urine Analysis Module","VRE Analysis Module (RUO)","Zone Reader Analysis Module (RUO)"],"integrations":["Laboratory Information Management Systems (LIMS)"],"data_standards":["FDA 21 CFR Part 11","PIC/S Guide Annex 11"],"api_available":"unknown","system_requirements":"Standard power and Ethernet connection","compliance":["FDA 21 CFR Part 11","PIC/S Guide Annex 11","HIPAA","GDPR","SOC 2","ISO 27001"],"certifications":["FDA 510(k) clearance as a Class II medical device","CE/MDR","ONC","ISO 13485"],"security_features":["Encryption","Role-Based Access Control (RBAC)","Audit logs","Two-Factor Authentication (2FA)"],"privacy_features":["Business Associate Agreement (BAA) available","Data anonymization","Data minimization"],"data_residency":"US/EU regions","customers":[],"user_reviews":[],"ratings":[],"support_channels":[],"training_options":[],"release_year":"","integration_partners":[],"id":"SW0556","slug":"apas-independence","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/apas-independence.json"}}