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§ 866.5785 Anti-<em>Saccharomyces cerevisiae</em> (<em>S. cerevisiae</em>) antibody (ASCA) test systems.

21 CFR 866.5785

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  3. Title 21
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  9. Subpart F
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  11. 21 CFR 866.5785
Citation21 CFR 866.5785
CorpusDaily eCFR
Displayed edition2026-04-27
Last updated2026-04-27

§ 866.5785 Anti-Saccharomyces cerevisiae (S. cerevisiae) 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]