Anti-Mutated Citrullinated Vimentin Igg
The Anti-Mutated Citrullinated Vimentin IgG (product code OQZ) is an in vitro immunoassay for the semi-quantitative measurement of IgG class autoantibodies against mutated citrullinated vimentin (MCV) in human serum or plasma. MCV autoantibodies are associated with rheumatoid arthritis, and the assay is used as an aid in diagnosis and monitoring. As an FDA Class 2 device under regulation 866.5775, it requires 510(k) premarket clearance and falls within the Immunology specialty. The device is eligible for third-party review and is neither an implant nor life-sustaining.
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Basic Information
- Product Code
- OQZ
- Device Class
- FDA class 2
- Regulation Number
- 866.5775
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
Definition
For the semi-quantitative measurement of IgG class autoantibodies against mutated citrullinated vimentin (MCV) in human serum or plasma.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K092399 | ANTI-MUTATED CITRULLINATED VIMENTIN EIA | Jul 01, 2010 | Substantially Equivalent | Orgentec Diagnostika GmbH |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.