Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230
The Skin Autoantibody Test for Bullous Pemphigoid (BP180 and BP230) (product code OEG) is an immunology in vitro diagnostic device used as an aid in the diagnosis of bullous pemphigoid, an autoimmune blistering skin disease, by detecting autoantibodies against bullous pemphigoid antigens 180 (BP180) and 230 (BP230) in patient samples. This device is FDA Class 2 under regulation 866.5660 in the Immunology specialty, requires 510(k) clearance, and is eligible for third-party review. It carries no implant or life-sustaining flags.
Basic Information
- Product Code
- OEG
- Device Class
- FDA class 2
- Regulation Number
- 866.5660
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
Definition
The device is intended as an aid in the diagnosis of bullous pemphigoid.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K193115 | EUROIMMUN Anti-BP230-CF ELISA (IgG) | Sep 17, 2020 | Substantially Equivalent | Euroimmun US, Inc. |
| K083615 | EUROIMMUN ANTI BP 180-4X ELISA (IGG) | Mar 16, 2009 | Substantially Equivalent | EUROIMMUN US INC |
| K071961 | MESACUP MODELS BP180 AND BP230 ELISA KITS | Aug 25, 2008 | Substantially Equivalent | MBL INTERNATIONAL CORPORATION |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.