| K-number | K252280 |
| Device name | Elecsys Anti-SARS-CoV-2 S |
| Applicant | Roche Diagnostics |
| Product code | QVP |
| Device class | Class II |
| Decision date | Apr 13, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 866.3983 |
The Elecsys Anti-SARS-CoV-2 S is a quantitative electrochemiluminescence immunoassay that detects total antibodies to SARS-CoV-2 in human serum and plasma samples collected 15 or more days after symptom onset. It is used to identify individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection, and runs on cobas e immunoassay analyzers with an 18-minute test time.
Both the Elecsys Anti-SARS-CoV-2 S (electrochemiluminescence) and predicate VITROS device (chemiluminescence) use similar immunoassay technology involving sandwich binding and washing steps with light/chemiluminescent signal measurement. Both devices employ calibrators and measure antibodies to SARS-CoV-2, though using different detection methods.
CLSI EP05-A3 (within-laboratory precision), CLSI EP05-A3 (reproducibility), CLSI EP06 2nd Edition (linearity), CLSI EP17-A2 (detection limits), CLSI EP07 and EP37 (drug interference).
The Elecsys Anti-SARS-CoV-2 S demonstrates substantial equivalence through comparable analytical performance (precision, linearity, detection limits) and superior or equivalent clinical performance. Clinical data show 100% positive percent agreement (95% CI 96.79–100%) and 99.97–100% negative percent agreement versus the composite comparator and negative controls, meeting or exceeding the predicate's claimed performance specifications.
View the full FDA submission: accessdata.fda.gov