# K261039: i-STAT Crea cartridge with the i-STAT 1 System

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Point of Care, Inc.
- Decided: Jun 26, 2026 after 88 days
- Product code: CGL (Electrode, Ion Based, Enzymatic, Creatinine)
- Device class: 2
- Regulation: 21 CFR 862.1225
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K070068 (2007). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171059: Nova StatSensor Creatinine Hospital Meter System, Nova Biomedical Corporation (2017) Summary page 5.

## Indications for use
The i-STAT Crea cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of creatinine in arterial, venous, or capillary whole blood in point of care or clinical laboratory settings. 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.

Source page: https://510kreport.com/device/K261039
Methodology: https://510kreport.com/methodology