Product Classification

• Device: cytokeratin fragments 21-1 eia kit
• Regulation Description: Tumor-associated antigen immunological test system.
• Definition: The CYFRA 21-1 EIA kit is intended for the quantitative determination of soluble cytokeratin 19 fragments in human serum. The assay is to be used as an aid in monitoring disease progression during the course of disease and treatment in lung cancer patients. Serial testing for patient CYFRA 21-1 assay values should be used in conjunction with other clinical methods used for monitoring lung cancer.
• Physical State: plastic microtiter plate, plate reader system
• Technical Method: Enzyme immunoassay to quantify soluble cytokeratin 19 in human serum.
• Target Area: Patient serum
• Regulation Medical Specialty: Immunology
• Review Panel: Immunology
• Product Code: OVK
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Immunology and Hematology Devices (DIHD)
• Submission Type: 510(k)
• Regulation Number: 866.6010
• 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

• beanstock consulting
• global quality and regulatory services
• regulatory technology services, llc