# K253839: Elecsys Anti-SARS-CoV-2

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics
- Decided: Dec 17, 2025 after 16 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: 2 generations back to DEN210040 (2023). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250768: Elecsys Anti-SARS-CoV-2, Roche Diagnostics (2025) Summary page 7.

## Indications for use
Elecsys Anti-SARS-CoV-2 is an immunoassay intended for the in vitro qualitative detection of total antibodies to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in human serum and Li-heparin, K2-EDTA and K3-EDTA plasma collected on or after 15 days post-symptom onset. The test is intended 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 601 immunoassay analyzer.

Source page: https://510kreport.com/device/K253839
Methodology: https://510kreport.com/methodology