K250666 is an FDA 510(k) clearance for the Alegria Flash CTD Screen. This device is classified as a Extractable Antinuclear Antibody, Antigen And Control (Class II - Special Controls, product code LLL).
Submitted by Zeus Scientific (Branchburg, US). The FDA issued a Cleared decision on October 22, 2025, 231 days after receiving the submission on March 5, 2025.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K250666 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 05, 2025 |
| Decision Date | October 22, 2025 |
| Days to Decision | 231 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | LLL - Extractable Antinuclear Antibody, Antigen And Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5100 |