K251697 is an FDA 510(k) clearance for the Flowflex® Plus Strep A Rapid Test Cassette. This device is classified as a Antigens, All Groups, Streptococcus Spp. (Class I - General Controls, product code GTY).
Submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on November 26, 2025, 177 days after receiving the submission on June 2, 2025.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3740.
| 510(k) Number | K251697 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 02, 2025 |
| Decision Date | November 26, 2025 |
| Days to Decision | 177 days |
| Submission Type | Dual Track |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | GTY — Antigens, All Groups, Streptococcus Spp. |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3740 |