De Novo · Granted
GrantedVITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · QVP Sars-Cov-2 Serology Test
Granted on May 5, 2023 as a new device type through De Novo after a 591-day review. 3 later devices descend from it.
- Decided
- May 5, 2023
- Review
- 591 days
- Class
- Class II
- Product code
- QVP
- Recalls
- None
3 later devices descend from it, 2 citing it directly.
- This deviceDEN210040 VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack…Ortho-Clinical Diagnostics, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK250768 Elecsys Anti-SARS-CoV-2Roche Diagnostics · 2025
- Descendant · cites it directly · 0 of its ownK252280 Elecsys Anti-SARS-CoV-2 SRoche Diagnostics · 2026
- Descendant · 2 generations on · 0 of its ownK253839 Elecsys Anti-SARS-CoV-2Roche Diagnostics · 2025
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN210040 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS… | Ortho-Clinical Diagnostics, Inc. | 2023 | — |
| +1 | K250768 | Elecsys Anti-SARS-CoV-2 | Roche Diagnostics | 2025 | — |
| +1 | K252280 | Elecsys Anti-SARS-CoV-2 S | Roche Diagnostics | 2026 | — |
| +2 | K253839 | Elecsys Anti-SARS-CoV-2 | Roche Diagnostics | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA De Novo 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
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K250768 (Roche Diagnostics, 2025) has gone furthest, with 1 descendant of its own.
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. 2023, 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?
For in vitro diagnostic and laboratory professional use. VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack when used in combination with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrator is a chemiluminescent immunoassay intended for the qualitative detection of total antibodies to SARS-CoV-2 in human serum and plasma (K2-EDTA, K3-EDTA and…
Read the full statement (150 words)
For in vitro diagnostic and laboratory professional use.
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack
The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack when used in combination with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrator is a chemiluminescent immunoassay intended for the qualitative detection of total antibodies to SARS-CoV-2 in human serum and plasma (K2-EDTA, K3-EDTA and lithium heparin) samples collected on or after 15 days post-symptom onset using the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems. The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrator
For use in the calibration of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems for the in vitro qualitative detection of total antibodies to SARS-CoV-2 in human serum and plasma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN210040 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN210040: VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN210040
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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