ACON Laboratories, Inc. · Class II · Cleared May 10, 2025
| K-number | K250377 |
| Device name | Flowflex Plus COVID-19 + Flu A/B Home Test |
| Applicant | ACON Laboratories, Inc. |
| Product code | SCA |
| Device class | Class II |
| Decision date | May 10, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 866.3987 |
The Flowflex Plus COVID-19 + Flu A/B Home Test is a lateral flow immunoassay for qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B antigens from anterior nasal swab samples. It is intended for over-the-counter home use by individuals aged 14 years or older (self-collected) or aged 2 years or older (adult-collected), with negative results requiring confirmation by molecular assay.
Not stated in this summary.
Not stated in this summary.
Not stated in this summary. The document confirms substantial equivalence was determined based on comparison to legally marketed predicate devices, but does not detail the specific predicate device(s) or the technical or performance characteristics upon which equivalence was established. The enclosure referenced in the clearance letter, which would typically contain this reasoning, is not included in the provided pages.
View the full FDA submission: accessdata.fda.gov