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U.S. Department of Health and Human Services

Product Classification

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Device tyrosine phosphatase (ia-2) autoantibody assay
Regulation Description Multiple autoantibodies immunological test system.
Definition The device is used for the semi-quantitative determination of autoantibodies against tyrosine phosphatase (IA-2) in human serum as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes).
Physical State n/a
Technical Method Radioimmunoassay
Target Area n/a
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeOIF
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Immunology and Hematology Devices (DIHD)
Submission Type 510(k)
Regulation Number 866.5660
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