(592 days)
For in vitro diagnostic and laboratory professional use.
The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack when used in combination with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator is a chemiluminescent immunoassay intended for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma (K2-EDTA and K3-EDTA) samples collected on or after 15 days post-symptom onset using the VITROS ECi/ECiO/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems. The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG 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 IgG 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 IgG antibodies to SARS-CoV-2 in human serum and plasma.
The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG test is a qualitative chemiluminescent immunoassay performed on the VITROS Systems (VITROS ECi/ECiO Immunodiagnostic System, VITROS 3600 Immunodiagnostic System, VITROS 5600 Integrated System and VITROS XT 7600 Integrated System) providing fully automated random-access testing.
The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG test is performed using the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack in combination with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator and the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Controls on the VITROS Systems.
The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack is supplied as ready to use and contains:
- 100 wells coated with 100ng/well of recombinant SARS-CoV-2 spike antigen derived from human cells.
- 18.0 mL assay reagent (buffer with bovine protein stabilizers and antimicrobial agent)
- 20.4 mL conjugate reagent [anti-human IgG (murine monoclonal) conjugated to horseradish peroxidase, 5ng/mL] in buffer with bovine protein stabilizers and antimicrobial agent.
The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator contains:
- 2 vials of VITROS Immunodiagnostic Products Anti-SARS-CoV-2 1gG Calibrator 0 (anti-SARS-CoV-2 IgG in anti-SARS-CoV-2 IgG negative human serum with antimicrobial agent, 1 mL)
- Lot calibration card
- Protocol card
- 8 calibrator bar code labels
The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Controls contain:
- 3 sets of VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Controls 1 and 2 (defibrinated human plasma with anti-microbial agent, 2 mL). Control 1 is non-reactive and Control 2 is reactive
The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG test is designed for use on the VITROS Systems. The VITROS Systems use the following ancillary reagents (general purpose reagents):
- VITROS Immunodiagnostic Products Signal Reagent
- VITROS Immunodiagnostic Products Universal Wash Reagent
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
Device: VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator (Chemiluminescent Immunoassay)
Purpose: Qualitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma, intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
1. Table of Acceptance Criteria and Reported Device Performance
The document describes the performance of the device rather than explicitly stating pre-defined acceptance criteria in a dedicated table. However, we can infer the implicit acceptance criteria from the observed results and the FDA's decision to grant the De Novo request.
| Performance Metric | Implied Acceptance Criteria (via observed performance & FDA acceptance) | Reported Device Performance (Summary) |
|---|---|---|
| Clinical Performance (PPA) | High PPA for samples collected ≥15 days post-symptom onset, sufficient to aid in identifying prior infection. | VITROS ECi/ECiQ: 93.86% (95% CI: 90.50%-96.10%) for ≥15 days post-symptom onset (N=293). |
| VITROS 3600/5600: 93.52% (95% CI: 90.10%-95.81%) for ≥15 days post-symptom onset (N=293). | ||
| VITROS XT 7600: 93.49% (95% CI: 90.10%-95.80%) for ≥15 days post-symptom onset (N=292). | ||
| Lower PPA for earlier time bins (0-7 days: ~41-45%; 8-14 days: ~52%). | ||
| Clinical Performance (NPA) | High NPA for presumed negative samples, demonstrating low false positive rate. | VITROS ECi/ECiQ/3600/5600: 99.01% (95% CI: 97.14%-99.66%) (N=304). |
| VITROS XT 7600: 99.01% (95% CI: 97.13%-99.66%) (N=303). | ||
| Precision/Reproducibility | Acceptable within-laboratory and between-laboratory variability for a diagnostic immunoassay. | Within-Laboratory: Total precision %CV for S/C values ranged from 3.4% - 32.2% depending on sample and instrument. |
| Reproducibility (Between-Laboratory): Total reproducibility %CV for S/C values ranged from 6.1% - 22.8% depending on sample and instrument. (%CVs are not meaningful for S/C results |
N/A