# K251281: Nova Max Creat eGFR Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Nova Biomedical Corporation
- Decided: Jan 21, 2026 after 272 days
- Product code: SHB (Creatinine Test System For At Home Prescription Use)
- 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 Nova Max Creat eGFR Monitoring System is comprised of the Nova Max Creat eGFR Monitor and the Nova Max Creat eGFR Test Strips. The Nova Max Creat eGFR Monitoring System is intended for in vitro diagnostic use for the quantitative measurement of creatinine and estimation of glomerular filtration rate (eGFR) in fresh capillary whole blood obtained from the fingertip of adult patients aged 18 and above. The system is intended for single patient home use by prescription only and should not be shared. It is intended for use by patients as an aid to monitor kidney function on the order of a treating healthcare professional.

Source page: https://510kreport.com/device/K251281
Methodology: https://510kreport.com/methodology