i-STAT Crea cartridge with the i-STAT 1 System— 510(k) K261039
Substantially EquivalentAbbott Point of Care, Inc.
FDA 510(k) clearance K261039 for i-STAT Crea cartridge with the i-STAT 1 System, Substantially Equivalent on 2026-06-26. Applicant: Abbott Point of Care, Inc.. Device class: 2.
Summary
Abbott Point of Care's clearance is for the i-STAT Crea cartridge with the i-STAT 1 System, filed under CGL, enzymatic ion-based creatinine electrodes. The record doesn't describe the cartridge beyond its name and the code name.
Class II, 21 CFR 862.1225. Clinical Chemistry is both the classification panel and the review panel. It was a Traditional 510(k).
Abbott Point of Care filed from Princeton, New Jersey. The decision came 88 calendar days after FDA received it (March 30 to June 26, 2026).
Clearance details
- Applicant
- Abbott Point of Care, Inc.
- Product code
- Product code CGL
- Device class
- Class 2
- Regulation
- 21 CFR 862.1225
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Princeton, NJ, US
Recent devices under product code CGL
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