# K221326: Nova Allegro HbA1c Assay, Nova Allegro Analyzer

- Pathway: 510(k) (Dual Track)
- Applicant: Nova Biomedical Corporation
- Decided: Nov 22, 2024 after 931 days
- Product code: LCP (Assay, Glycosylated Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.7470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K951361 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171650: Alere Afinion HbA1c and ACR on Afinion 2 analyzer, Abbott Rapid Diagnostics (2017) Summary page 5.

## Indications for use
The Nova Allegro HbA1c Assay is intended for in vitro diagnostic use on the Nova Allegro Analyzer for the quantitative determination of the glycated Hemoglobin (% hemoglobin A1c) in capillary whole blood obtained from the fingertip. The results from this assay are intended to be used for the monitoring of long-term blood glucose/metabolic control in individuals with diabetes mellitus. 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/K221326
Methodology: https://510kreport.com/methodology