Product Classification

• Device: automated occult blood analyzer
• Regulation Description: Occult blood test.
• Definition: The automated test system is intended for the qualitative detection of fecal occult blood in feces by professional laboratories. The automated test is used for the determination of gastrointestinal bleeding.
• Physical State: The system consists of an analyzer, test reagents (antibody, calibrators and controls) and collection devices containing buffer.
• Technical Method: The test reagent contains an immunoassay utilizing monoclonal and polyclonal antibodies for human hemoglobin. A light beam measures the antibody reaction, i.e. the absorbance fo the reaction mixture measures the concentration of hemoglobin in the specimen.
• Target Area: fecal samples
• Regulation Medical Specialty: Hematology
• Review Panel: Hematology
• Product Code: OOX
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Immunology and Hematology Devices (DIHD)
• Submission Type: 510(k)
• Regulation Number: 864.6550
• 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
• beanstock consulting
• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc