DEN210038 is an FDA 510(k) submission for the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator. This device is classified as a Sars-cov-2 Serology Test (Class II - Special Controls, product code QVP).
Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Not Cleared (DENG) decision on May 5, 2023.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3983. A Sars-cov-2 Serology Test Is A Prescription In Vitro Diagnostic Device For The Detection Of Specific Binding Antibodies To Sars-cov-2 In Clinical Specimens. The Detection Of Sars-cov-2 Antibodies Is Intended To Aid In Identifying Individuals With An Adaptive Immune Response To Sars-cov-2. The Test Is Not Intended For The Diagnosis Of Acute Sars-cov-2 Infection, Nor Screening Blood, Plasma, Cells, Or Tissue Donors..
| 510(k) Number | DEN210038 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | September 20, 2021 |
| Decision Date | May 05, 2023 |
| Days to Decision | 592 days |
| Submission Type | Direct |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | QVP — Sars-cov-2 Serology Test |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3983 |
| Definition | A Sars-cov-2 Serology Test Is A Prescription In Vitro Diagnostic Device For The Detection Of Specific Binding Antibodies To Sars-cov-2 In Clinical Specimens. The Detection Of Sars-cov-2 Antibodies Is Intended To Aid In Identifying Individuals With An Adaptive Immune Response To Sars-cov-2. The Test Is Not Intended For The Diagnosis Of Acute Sars-cov-2 Infection, Nor Screening Blood, Plasma, Cells, Or Tissue Donors. |