# K243561: Nano-Check Influenza+COVID-19 Dual Test

- Pathway: 510(k) (Dual Track)
- Applicant: Nano-Ditech Corporation
- Decided: Jun 17, 2025 after 211 days
- Product code: SCA (Multi-Analyte Respiratory Virus Antigen Detection Test)
- Device class: 2
- Regulation: 21 CFR 866.3987
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN240029 (2024). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN240029: Healgen Rapid Check COVID-19/Flu A&B Antigen Test, Healgen (2024) Summary page 5.

## Indications for use
The Nano-Check Influenza+COVID-19 Dual Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly in anterior nasal swab (ANS) samples from individuals with signs and symptoms of respiratory tract infection. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar. All negative results are presumptive and should be confirmed with a molecular assay, if necessary, for patient management. Negative results do not rule out infection with influenza or SARS-CoV-2 and should not be used as the sole basis for treatment or patient management decisions. Positive results do not rule out bacterial infection or co-infection with other viruses.

Source page: https://510kreport.com/device/K243561
Methodology: https://510kreport.com/methodology