# K252280: Elecsys Anti-SARS-CoV-2 S

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Apr 13, 2026 after 265 days
- Product code: QVP (Sars-Cov-2 Serology Test)
- Device class: 2
- Regulation: 21 CFR 866.3983
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN210040 (2023). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN210040: VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators, Ortho-Clinical Diagnostics, Inc. (2023) Summary page 5.

## Indications for use
Elecsys Anti-SARS-CoV-2 S is an electrochemiluminescence immunoassay intended for quantitative detection of total antibodies to SARS-CoV-2 in human serum and plasma (lithium heparin, K2-EDTA, K3-EDTA, and sodium citrate) samples collected on or after 15 days post-symptom onset. The Elecsys Anti-SARS-CoV-2 S assay is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K252280
Methodology: https://510kreport.com/methodology