NBT · Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)
Immunology · 21 CFR 866.5785 · Class 2
Overview
| Product Code | NBT |
|---|---|
| Device Name | Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae) |
| 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 (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K071711 | ASCA-CHEK | Techlab Inc., Corporate Research Center | Nov 7, 2007 | SESE |
| K051927 | TECHLAB ASCA-CHEK | Techlab, Inc. | Apr 6, 2006 | SESE |
| K051492 | AESKULISA ASCA A | Aesku, Inc. | Nov 14, 2005 | SESE |
| K042579 | BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT | The Binding Site | Jul 28, 2005 | SESE |
| K032860 | IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA) | Immco Diagnostics, Inc. | Mar 18, 2004 | SESE |
| K032850 | IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG) | Immco Diagnostics, Inc. | Mar 18, 2004 | SESE |
| K000733 | QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA | Inova Diagnostics, Inc. | May 21, 2001 | SESE |
| DEN000007 | QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA | Inova Diagnostics, Inc. | Aug 16, 2000 | DENG |
Top Applicants
- Inova Diagnostics, Inc. — 2 clearances
- Immco Diagnostics, Inc. — 2 clearances
- The Binding Site — 1 clearance
- Techlab, Inc. — 1 clearance
- Techlab Inc., Corporate Research Center — 1 clearance
