510(k) · Cleared
ClearedElecsys Anti-SARS-CoV-2 S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · QVP Sars-Cov-2 Serology Test
Cleared on Apr 13, 2026 as substantially equivalent to DEN210040 (Ortho-Clinical Diagnostics, Inc., 2023) after a 265-day review. Its family tree reaches back 1 generation to 2023.
- Decided
- Apr 13, 2026
- Review
- 265 days
- Class
- Class II
- Product code
- QVP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN210040 (2023). No later device cites it as a predicate yet.
- Root · 1 generation backDEN210040 VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack…Ortho-Clinical Diagnostics, Inc. · 2023
- This deviceK252280 Elecsys Anti-SARS-CoV-2 SRoche Diagnostics · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN210040 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS… | Ortho-Clinical Diagnostics, Inc. | 2023 | — |
| 0 (this device) | K252280 | Elecsys Anti-SARS-CoV-2 S | Roche Diagnostics | 2026 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QVP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QVP device
- #1 K250768 Elecsys Anti-SARS-CoV-2score 12.5 · 1 generation · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN210040 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS…Summary page 5…er 866.3983 QVP Product Codes JJX (for optional CalCheck Anti-SARS-CoV-2 S) DEN210040: VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Predicate Device Reagent Pack, VITROS Immunodiagnostic Product… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate DEN210040.
How does its category compare?
All QVP devicesQVP Sars-Cov-2 Serology Test: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QVP
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QVP
Too few QVP 510(k)s in any year since 2007 to give a median.
Recalls per year · QVP
No recall names QVP since 2007.
Adverse event reports per year · QVP
No MAUDE report names QVP since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252280 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252280: Elecsys Anti-SARS-CoV-2 S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252280
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026