Product Classification

• Device: creatinine test system for at home prescription use
• Regulation Description: Creatinine test system.
• Definition: For the quantitative measurement of creatinine in home use settings by patients as an aid to monitor kidney function. 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: SHB
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Chemistry and Toxicology Devices (DCTD)
• Submission Type: 510(k)
• Regulation Number: 862.1225
• 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