510(k) · Cleared
ClearedFlowflex Plus RSV + Flu A/B + COVID Home Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ACON Laboratories, Inc. · SCA Multi-Analyte Respiratory Virus Antigen Detection Test
Cleared on Oct 22, 2025 after a 138-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Oct 22, 2025
- Review
- 138 days
- Class
- Class II
- Product code
- SCA
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in SCA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new SCA device
- #1 K243256 WELLlife™ COVID-19 / Influenza A&B Home Test…score 20.7 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All SCA devicesSCA Multi-Analyte Respiratory Virus Antigen Detection Test: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · SCA
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SCA
116in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · SCA
No recall names SCA since 2007.
Adverse event reports per year · SCA
4in 2025
MAUDE reports naming product code SCA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 10 | 116 | 0 | 4 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Flowflex Plus RSV + Flu A/B + COVID Home 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. Symptoms of respiratory infections due to RSV, influenza, and SARS-CoV-2 can be similar. This test is for…
Read the full statement (181 words)
The Flowflex Plus RSV + Flu A/B + COVID Home 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. Symptoms of respiratory infections due to RSV, influenza, and SARS-CoV-2 can be similar.
This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged six (6) months or older.
All negative results are presumptive and should be confirmed with an FDA-cleared molecular assay when determined to be appropriate by a healthcare provider. Negative results do not rule out infection with RSV, influenza, SARS-CoV-2 or other pathogens.
Individuals who test negative and/or experience continued or worsening symptoms, such as fever, cough and/or shortness of breath should therefore seek follow-up care from their healthcare provider.
Positive results do not rule out co-infection with other respiratory pathogens and therefore do not substitute for a visit to a healthcare provider or appropriate follow-up.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K251749 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251749: Flowflex Plus RSV + Flu A/B + COVID Home Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251749
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026