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U.S. Department of Health and Human Services

Product Classification

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Device uric acid test system for at home prescription use
Regulation Description Uric acid test system.
Definition For the quantitative measurement of uric acid in home use settings by patients diagnosed with gout. This device is for prescription use only.
Physical State Handheld meter
Technical Method Quantitative enzymatic activity assay
Target Area Capillary whole blood, in vitro diagnostic use.
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodePTC
Premarket Review Division of Chemistry and Toxicology Devices (DCTD)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type 510(k)
Regulation Number 862.1775
Device Class 1
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