21 CFR 866.5785 — Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)
Immunology (IM) · Part 866 Subpart F—Immunological Test Systems · § 866.5785
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.
Classification Rationale
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.”
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| NBT | Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae) | 2 | 8 | 3rd Party |
| OKM | Antibodies, Outer-Membrane Proteins | 2 | 1 | 3rd Party |
Special Controls
NBT — Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)
*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.”
eCFR
NBT — Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)
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.”
Ecfr Llm
OKM — Antibodies, Outer-Membrane Proteins
*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.”
eCFR
