Product Classification

• Device: antibodies, outer-membrane proteins
• Regulation Description: Anti-Saccharomyces cerevisiae (S. cerevisiae) antibody (ASCA) test systems.
• Definition: For the detection of anti-outer membrane protein (anti-OMP) antibodies in human serum. To aid in the diagnosis of Crohn's Disease.
• Physical State: Comprised of antigen coated microtiter plate, enzyme conjugate, substrate, controls
• Technical Method: Uses enzyme-linked, immunosorbent assay (ELISA) to identify the presence of anti-OMP antibodies.
• Target Area: human serum
• Regulation Medical Specialty: Immunology
• Review Panel: Immunology
• Product Code: OKM
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Immunology and Hematology Devices (DIHD)
• Submission Type: 510(k)
• Regulation Number: 866.5785
• 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