21 CFR 866.3983 — Sars-Cov-2 Serology Test

Microbiology (MI) · Part 866 Subpart D—Serological Reagents · § 866.3983

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.

Product Codes