Product Classification

• 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 Code: PTC
• Premarket Review: Office of In Vitro Diagnostics (OHT7); 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 Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc