21 CFR § 866.5785 - Anti- () antibody (ASCA) test systems.

---
identifier: "/us/cfr/t21/s866.5785"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 866.5785 - Anti- () antibody (ASCA) test systems."
title_number: 21
title_name: "Food and Drugs"
section_number: "866.5785"
section_name: "Anti- () antibody (ASCA) test systems."
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"
---


# 866.5785 Anti- () antibody (ASCA) test systems.

(a) *Identification.* The Anti-*Saccharomyces cerevisiae* (*S. cerevisiae*) antibody (ASCA) test system is an in vitro diagnostic device that consists of the reagents used to measure, by immunochemical techniques, antibodies to *S. cerevisiae* (baker's or brewer's yeast) in human serum or plasma. Detection of *S. cerevisiae* antibodies may aid in the diagnosis of Crohn's disease.

(b) *Classification.* Class II (special controls). The special control is FDA's “Guidance for Industry and FDA Reviewers: Class II Special Control Guidance Document for Anti-*Saccharomyces cerevisiae* (*S. cerevisiae*) Antibody (ASCA) Premarket Notifications.”

[65 FR 70307, Nov. 22, 2000]