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U.S. Department of Health and Human Services

Product Classification
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Device thymidine kinase activity
Regulation Description Tumor-associated antigen immunological test system.
Definition In vitro test to measure thymidine kinase activity (TKa) to aid in monitoring disease progression of breast cancer patients.
Physical State Immunoassay reagents, calibrators and controls, 96-well plate, general microplate reader or automated instrument with software
Technical Method Enzymatic reaction and enzyme-linked immunosorbent assay.
Target Area Venous blood specimens, but other specimen types may be possible
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeQTE
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Immunology and Hematology Devices (DIHD)
Submission Type 510(k)
Regulation Number 866.6010
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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