i-STAT Crea cartridge with the i-STAT 1 System
Device Facts
| Record ID | K261039 |
|---|---|
| Device Name | i-STAT Crea cartridge with the i-STAT 1 System |
| Applicant | Abbott Point of Care, Inc. |
| Product Code | CGL · Clinical Chemistry |
| Decision Date | Jun 26, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1225 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
