QVP · Sars-Cov-2 Serology Test
Microbiology · 21 CFR 866.3983 · Class 2
Overview
| Product Code | QVP |
|---|---|
| Device Name | Sars-Cov-2 Serology Test |
| Regulation | 21 CFR 866.3983 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
Identification
The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG test is a qualitative chemiluminescent immunoassay intended for the detection of IgG antibodies to SARS-CoV-2 in human serum and plasma (K2-EDTA and K3-EDTA). It is performed on the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems. The 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.
Classification Rationale
Class II (special controls). The device is classified under 21 CFR 866.3983, SARS-CoV-2 serology test, and is subject to special controls to mitigate risks such as false test results, failure to correctly interpret results, and failure to correctly operate the device.
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252280 | Elecsys Anti-SARS-CoV-2 S | Roche Diagnostics | Apr 13, 2026 | SESE |
| K253839 | Elecsys Anti-SARS-CoV-2 | Roche Diagnostics | Dec 17, 2025 | SESE |
| K250768 | Elecsys Anti-SARS-CoV-2 | Roche Diagnostics | Jun 10, 2025 | SESE |
| DEN210040 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators | Ortho-Clinical Diagnostics, Inc. | May 5, 2023 | DENG |
| DEN210038 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator | Ortho-Clinical Diagnostics, Inc. | May 5, 2023 | DENG |
Top Applicants
- Roche Diagnostics — 3 clearances
- Ortho-Clinical Diagnostics, Inc. — 2 clearances
