| K-number | K253839 |
| Device name | Elecsys Anti-SARS-CoV-2 |
| Applicant | Roche Diagnostics |
| Product code | QVP |
| Device class | Class II |
| Decision date | Dec 17, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 866.3983 |
Elecsys Anti-SARS-CoV-2 is an immunoassay for in vitro qualitative detection of total antibodies to SARS-CoV-2 in human serum and certain plasma types collected 15+ days after symptom onset. The test identifies individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection, and runs on the cobas e 601 analyzer with an 18-minute assay time.
The candidate device (K253839) is identical to the predicate (K250768) in all technological aspects: same sandwich immunoassay principle using SARS-CoV-2 nucleocapsid antigen, same reagent composition (streptavidin microparticles, biotinylated and ruthenium-labeled antigens), same sample types (serum and EDTA/heparin plasma), and same calibration and control procedures. The only numerical difference is the analytical cutoff sensitivity (4.776 BAU/mL vs. 1.137 BAU/mL for the predicate).
Not stated in this summary.
Substantial equivalence is supported because the candidate device shares identical intended use, regulatory classification (Class II, 21 CFR 866.3983), test principle, reagent composition, sample matrices, calibration methods, and interpretation of results as the predicate Elecsys Anti-SARS-CoV-2 (K250768). All technological characteristics are the same except for the analytical cutoff sensitivity parameter.
View the full FDA submission: accessdata.fda.gov