# K261212: Flowflex Plus RSV + Flu A/B + COVID Rapid Test

- Pathway: 510(k) (Dual Track)
- Applicant: ACON Laboratories, Inc.
- Decided: Jul 10, 2026 after 87 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Flowflex Plus RSV + Flu A/B + COVID Rapid Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of respiratory syncytial virus (RSV), influenza A, influenza B, and SARS-CoV-2 protein antigens directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection. Clinical signs and symptoms of respiratory viral infection due to RSV, influenza, and SARS-CoV-2 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 RSV, 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/K261212
Methodology: https://510kreport.com/methodology