Product Classification

• Device: auto-antibodies; phosphatidylserine, prothrombin, phosphatidylserine/prothrombin complex
• Regulation Description: Multiple autoantibodies immunological test system.
• Definition: For the detection of autoantibodies to phosphatidylserine (PS), prothrombin (PT), or phosphatidylserine/prothrombin (PS/PT) complex in human serum or plasma. To aid in the diagnosis of certain autoimmune thrombotic disorders such as anti-phospholipid syndrome and those secondary to systemic lupus erythematosus or other lupus-like diseases
• Physical State: Microtiter plate coated with purified antigen, enzyme labelled anti-human antibody substrate
• Technical Method: ELISA
• Target Area: peripheral blood samples
• Regulation Medical Specialty: Immunology
• Review Panel: Immunology
• Product Code: OPN
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Immunology and Hematology Devices (DIHD)
• Submission Type: 510(k)
• Regulation Number: 866.5660
• 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