Product Classification

• Device: 11-dehydro thromboxane b2 kit, urinary
• Regulation Description: Automated platelet aggregation system.
• Definition: The test kit is an enzyme-linked immunoassay (elisa) to determine levels of 11-dehydro thromboxane b2 (11dhtxb2) in human urine, which aids in the qualitative detection of aspirin effect in apparently healthy individuals post ingestion. For professional use only.
• Physical State: n/a
• Technical Method: An enzyme linked immunosorbent assay (ELISA) for the detection of 11dhTxB2.
• Target Area: n/a
• Regulation Medical Specialty: Hematology
• Review Panel: Hematology
• Product Code: OBW
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Immunology and Hematology Devices (DIHD)
• Submission Type: 510(k)
• Regulation Number: 864.5700
• 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

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