Autoantibodies, Nuclear Body Protein, Sp100
The Nuclear Body Protein SP100 Autoantibody device is an in vitro diagnostic assay used to detect autoantibodies to SP100 (nuclear body protein SP100) in human serum or plasma as an aid in the diagnosis of primary biliary cirrhosis. Sp100 autoantibodies are a serological marker associated with this chronic autoimmune cholestatic liver disease. It is an FDA Class 2 device regulated under 21 CFR 866.5090 in the Immunology specialty, with product code NUM, requiring 510(k) clearance. Third-party review is available. It is not an implant and does not carry life-sustaining support designation.
Research product code NUM in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- NUM
- Device Class
- FDA class 2
- Regulation Number
- 866.5090
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
Definition
THE DEVICE IS USED FOR THE DETECTION, IN HUMAN SERUM OR PLASMA, OF AUTOANTIBODIES TO SP100 (NUCLEAR BODY PROTEIN SP100) AS AN AID IN THE DIAGNOSIS OF PRIMARY BILIARY CIRRHOSIS.
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 |
|---|---|---|---|---|
| K050662 | QUANTA LITE SP100 ELISA | Jun 13, 2005 | Substantially Equivalent | 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.