OKM · Antibodies, Outer-Membrane Proteins
Immunology · 21 CFR 866.5785 · Class 2
Overview
| Product Code | OKM |
|---|---|
| Device Name | Antibodies, Outer-Membrane Proteins |
| Regulation | 21 CFR 866.5785 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
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.”
Special Controls
*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.”
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K081248 | QUANTA LITE OMP PLUS ELISA | Inova Diagnostics, Inc. | Oct 27, 2008 | SESE |
Top Applicants
- Inova Diagnostics, Inc. — 1 clearance
