# K171059: Nova StatSensor Creatinine Hospital Meter System

- Pathway: 510(k) (Special)
- Applicant: Nova Biomedical Corporation
- Decided: May 26, 2017 after 46 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: 1 generation back to K070068 (2007). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070068: Nova Statsensor Creatinine Hospital Meter, Control Solutions,Linearity Solutions, and Test Strips, Nova Biomedical Corp. (2007) Summary page 4.

## Most influential descendants
- K261039: i-STAT Crea cartridge with the i-STAT 1 System (2026), 0 descendants of its own
- K251281: Nova Max Creat eGFR Monitoring System (2026), 0 descendants of its own

## Indications for use
The Nova StatSensor Creatinine Hospital Meter System consists of the StatSensor Creatinine Hospital Meter and the StatSensor Creatinine Test Strips. The Nova StatSensor Creatinine Hospital Meter System is intended for in vitro diagnostic use by healthcare professionals and for Point-Of-Care usage for the quantitative measurement of creatinine in capillary, venous, and arterial whole blood. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis. Not for use in neonates.

Source page: https://510kreport.com/device/K171059
Methodology: https://510kreport.com/methodology