Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)
The Saccharomyces Cerevisiae Antibody Test (ASCA) is an in vitro diagnostic immunology device used to detect anti-Saccharomyces cerevisiae antibodies (ASCA) in patient serum, which are a marker associated with Crohn's disease and are used to help differentiate Crohn's disease from ulcerative colitis in inflammatory bowel disease diagnostics. Classified as FDA Class 2, it requires 510(k) premarket clearance under regulation 866.5785 (Immunology specialty). This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- NBT
- Device Class
- FDA class 2
- Regulation Number
- 866.5785
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K071711 | ASCA-CHEK | Nov 07, 2007 | Substantially Equivalent | Techlab Inc., Corporate Research Center |
| K051927 | TECHLAB ASCA-CHEK | Apr 06, 2006 | Substantially Equivalent | Techlab, Inc. |
| K051492 | AESKULISA ASCA A | Nov 14, 2005 | Substantially Equivalent | Aesku, Inc. |
| K042579 | BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT | Jul 28, 2005 | Substantially Equivalent | The Binding Site |
| K032860 | IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA) | Mar 18, 2004 | Substantially Equivalent | Immco Diagnostics, Inc. |
| K032850 | IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG) | Mar 18, 2004 | Substantially Equivalent | Immco Diagnostics, Inc. |
| K000733 | QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA | May 21, 2001 | Substantially Equivalent | Inova Diagnostics, Inc. |
| DEN000007 | QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA | Aug 16, 2000 | Unknown | Inova Diagnostics, Inc. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.