21 CFR 866.5820 — System, Test, Systemic Lupus Erythematosus

Immunology (IM) · Part 866 Subpart F—Immunological Test Systems · § 866.5820

Identification

A systemic lupus erythematosus (SLE) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum and other body fluids that react with cellular nuclear double-stranded deoxyribonucleic acid (DNA) or other nuclear constituents that are specifically diagnostic of SLE. Measurement of nuclear double-stranded DNA antibodies aids in the diagnosis of SLE (a multisystem autoimmune disease in which tissues are attacked by the person's own antibodies).

Classification Rationale

Class II (performance standards).

Product Codes