# DEN210040: VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators

- Pathway: De Novo (Direct)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: May 5, 2023 after 591 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
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K250768: Elecsys Anti-SARS-CoV-2 (2025), 1 descendant of its own
- K252280: Elecsys Anti-SARS-CoV-2 S (2026), 0 descendants of its own
- K253839: Elecsys Anti-SARS-CoV-2 (2025), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/DEN210040
Methodology: https://510kreport.com/methodology