# K221813: Nova Allegro UACR Assay, Nova Allegro Analyzer

- Pathway: 510(k) (Dual Track)
- Applicant: Nova Biomedical Corporation
- Decided: Nov 19, 2024 after 881 days
- Product code: CGX (Alkaline Picrate, Colorimetry, 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 K963142 (1996). 2 ancestors in all.
1 later device descends from it; 1 cites 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)
- K072409: Afinion Acr and Acr Control, Axis-Shield Poc AS (2008) Summary page 5.

## Most influential descendants
- K252206: Nova Allegro UACR Assay, Nova Allegro Analyzer (2026), 0 descendants of its own

## Indications for use
The Nova Allegro urine albumin creatinine ratio (UACR) Assay is intended for the quantitative determination of albumin, creatinine, and the albumin/creatinine ratio (UACR) in human urine. The measurement of urine albumin, creatinine, and albumin/creatinine ratio aids in the early diagnosis of nephropathy. The Nova Allegro Analyzer is intended for in vitro diagnostic use in clinical laboratory and near-patient testing (point-of- care) settings for the quantitative determination of Nova Allegro Assays using Nova Allegro Test Cartridges.

Source page: https://510kreport.com/device/K221813
Methodology: https://510kreport.com/methodology