Nova Biomedical Corporation · Class II · Cleared Jan 9, 2026
| K-number | K252206 |
| Device name | Nova Allegro UACR Assay, Nova Allegro Analyzer |
| Applicant | Nova Biomedical Corporation |
| Product code | CGX |
| Device class | Class II |
| Decision date | Jan 9, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 862.1225 |
The Nova Allegro UACR Assay and Analyzer is an automated point-of-care diagnostic device that quantitatively measures albumin, creatinine, and the albumin-to-creatinine ratio (UACR) in human urine samples. It is intended for use in clinical laboratories and near-patient testing settings to aid in early diagnosis of nephropathy.
The device uses immunoturbidimetric measurement for albumin and alkaline colorimetric (Benedict/Behre) chemistry for creatinine, with a sample volume of 25 μL. Key technical specifications include measurement ranges of 5.0-300 mg/L for albumin, 15.0-500 mg/dL for creatinine, and 1.0-2,000 mg/g for ACR, with analysis time of ≤7 minutes. The analyzer features two analytical bays, color touchscreen display, barcode scanner, printer, and data export via Ethernet and USB.
Not stated in this summary.
The Nova Allegro UACR Assay and Analyzer demonstrates substantial equivalence to the predicate device (K221813) through identical intended use, intended users, sample type, sample volume, measurement ranges, and test principles. Performance testing showed that modifications did not impact precision, linearity, analytical specificity, analytical sensitivity, or accuracy compared to the predicate, and the device performed as intended with successful validation of the sample volume verification system.
View the full FDA submission: accessdata.fda.gov