K251281 is an FDA 510(k) clearance for the Nova Max Creat eGFR Monitoring System. This device is classified as a Creatinine Test System For At Home Prescription Use (Class II - Special Controls, product code SHB).
Submitted by Nova Biomedical Corporation (Walham, US). The FDA issued a Cleared decision on January 21, 2026, 272 days after receiving the submission on April 24, 2025.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1225. For The Quantitative Measurement Of Creatinine In Home Use Settings By Patients As An Aid To Monitor Kidney Function. This Device Is For Prescription Use Only..
| 510(k) Number | K251281 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 24, 2025 |
| Decision Date | January 21, 2026 |
| Days to Decision | 272 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | SHB — Creatinine Test System For At Home Prescription Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1225 |
| Definition | For The Quantitative Measurement Of Creatinine In Home Use Settings By Patients As An Aid To Monitor Kidney Function. This Device Is For Prescription Use Only. |