| K-number | K250408 |
| Device name | Alegria Flash ENA Screen |
| Applicant | Zeus Scientific |
| Product code | LLL |
| Device class | Class II |
| Decision date | Sep 19, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 866.5100 |
The Alegria Flash ENA Screen is a chemiluminescent immunoassay kit that qualitatively screens for IgG autoantibodies to seven specific antigens (Jo-1, SSA-52, SSA-60, SS-B, Scl-70, Sm, SmRNP) in human serum. It is intended as an aid in diagnosing connective tissue diseases including Sjögren's syndrome, systemic lupus erythematosus, systemic sclerosis, mixed connective tissue disease, CREST syndrome, polymyositis, and dermatomyositis, and must be performed on the Alegria Flash instrument.
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 predicate devices, but does not articulate the specific technological similarities or performance comparisons that formed the basis of that determination.
View the full FDA submission: accessdata.fda.gov