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U.S. Department of Health and Human Services

Product Classification

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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 CodeOOX
Premarket Review Division of Immunology and Hematology Devices (DIHD)
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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons