Product Classification

• Device: flow cytometric reagents and accessories.
• Regulation Description: Automated differential cell counter.
• Definition: To identify and classify cells or other particles in suspension by their inherent physical properties or associated fluorescent molecules in order to provide information about the distribution or number cells in suspension or their level of protein expression. These characteristics may aid in the diagnosis of conditions such as immunodeficiency and cancer.
• Physical State: May include flow cytometers, monoclonal antibodies, lysis reagents, processing reagents, automated processing devices or pipetting devices.
• Technical Method: Particles in suspension may be treated with fluorescent conjugated antibodies or fluorogenic compounds followed by interrogation in a flow cytometer that enumerates and characterizes each particle based on its physical and fluorescent characteristics.
• Target Area: Peripheral whole blood specimens, lymphoid biopsies, and neoplastic tissues.
• Regulation Medical Specialty: Hematology
• Review Panel: Hematology
• Product Code: OYE
• Premarket Review: Division of Immunology and Hematology Devices (DIHD); Division of Immunology and Hematology Devices (DIHD)
• Submission Type: 510(k)
• Regulation Number: 864.5220
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• aabb
• beanstock consulting
• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc