NYO · Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody
Immunology · 21 CFR 866.5100 · Class 2
Overview
| Product Code | NYO |
|---|---|
| Device Name | Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody |
| 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 (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K202541 | EliA RNA Pol III | Phadia AB | Sep 13, 2021 | SESE |
| K172078 | ImmuLisa Enhanced RNA POL III Antibody ELISA | Immco Diagnostics, Inc. | Mar 30, 2018 | SESE |
| K070066 | QUANTA LITE RNA POL III ELISA | Inova Diagnostics, Inc. | Apr 11, 2007 | SESE |
| K060431 | ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805 | Mbl International Corporation | Jun 19, 2006 | SESE |
Top Applicants
- Immco Diagnostics, Inc. — 1 clearance
- Inova Diagnostics, Inc. — 1 clearance
- Mbl International Corporation — 1 clearance
- Phadia AB — 1 clearance
