21 CFR § 866.5820 - Systemic lupus erythematosus immunological test system.

---
identifier: "/us/cfr/t21/s866.5820"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 866.5820 - Systemic lupus erythematosus immunological test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "866.5820"
section_name: "Systemic lupus erythematosus immunological test system."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "866"
part_name: "IMMUNOLOGY AND MICROBIOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "47 FR 50823, Nov. 9, 1982, unless otherwise noted."
cfr_part: "866"
---


# 866.5820 Systemic lupus erythematosus immunological test system.

(a) *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).

(b) *Classification.* Class II (performance standards).