Product Classification

• Device: automated indirect immunofluorescence microscope and software-assisted system for clinical use
• Definition: Automated system consisting of a fluorescence microscope and software that acquires, analyzes, stores and displays digital images of stained indirect immunofluorescent slides. It is intended as an aid in the detection and classification of certain antibodies by indirect immunofluorescent technology. A trained operator must confirm all device generated results.
• Physical State: The system may include a fluorescence microscope with light source, a motorized microscope stage, dedicated instrument controls, a camera, a computer, a sample processor, and other hardware components. The software may include fluorescent signal acquisition and processing software, data storage, data transferring mechanisms, and assay specific algorithms to suggest results. A trained operator must confirm results generated with the device.
• Technical Method: indirect immunofluorescent technology
• Target Area: human serum
• Regulation Medical Specialty: Immunology
• Review Panel: Immunology
• Product Code: PIV
• Premarket Review: Division of Immunology and Hematology Devices (DIHD); Division of Immunology and Hematology Devices (DIHD)
• Submission Type: 510(k)
• Regulation Number: 866.4750
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• global quality and regulatory services
• regulatory technology services, llc
• sgs north america