OBE · Anti-Ss-A 52 Autoantibodies
Immunology · 21 CFR 866.5100 · Class 2
Overview
| Product Code | OBE |
|---|---|
| Device Name | Anti-Ss-A 52 Autoantibodies |
| Regulation | 21 CFR 866.5100 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
Identification
An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K141655 | QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLS | Inova Diagnostics, Inc. | Mar 5, 2015 | SESE |
| K063565 | QUANTA LITE SS-A 52 ELISA | Inova Diagnostics, Inc. | Apr 4, 2007 | SESE |
Top Applicants
- Inova Diagnostics, Inc. — 2 clearances
