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U.S. Department of Health and Human Services

Product Classification
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Device test, cell mediated immune response, liver and small bowel transplant/transplantation
Definition The test is a qualitative prognostic test intended to be used in patients less than 21 years old with liver or small bowel transplantation. The test is an aid in the evaluation of the risk of acute cellular rejection (ACR) and must be used in conjunction with biopsy, standard clinical assessment and other laboratory information.
Physical State flow cytometers, fluorochrome labeled antibodies, sodium heparin blood collection tubes, processing reagents, automated processing devices or pipetting devices.
Technical Method Stimulated Cell Culture
Target Area Peripheral human whole blood specimens
Review Panel Clinical Chemistry
Product CodePHK
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Chemistry and Toxicology Devices (DCTD)
Not Classified Reason HDE
Submission Type HDE - Humanitarian Device Exemption
Device Class Not Classified
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 Not Third Party Eligible
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