LSW · Anti-Dna Antibody, Antigen And Control
Immunology · 21 CFR 866.5100 · Class 2
Overview
| Product Code | LSW |
|---|---|
| Device Name | Anti-Dna Antibody, Antigen And Control |
| 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 (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K172348 | AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10 | Aesku.Diagnostics GmbH & Co. KG | Feb 16, 2018 | SESE |
| K152013 | QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls | Inova Diagnostics, Inc. | Apr 11, 2016 | SESE |
| K081251 | MODIFICATION TO AESKULISA DS DNA G | Aesku Diagnostics | May 13, 2008 | SESE |
| K072393 | ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01 | Phadia US, Inc. | Dec 7, 2007 | SESE |
| K060380 | FIDIS DSDNA | Biomedical Diagnostics (Bmd) SA | May 2, 2006 | SESE |
| K041628 | AESKULISA DS DNA G | Aesku Diagnostics | Oct 14, 2004 | SESE |
| K921658 | ANTI-DSDNA ANTIBODY TEST | Immco Diagnostics, Inc. | Mar 22, 1993 | SESE |
| K872085 | THE GAMMA-B ANTI-DS DNA KIT & OPTIONAL CONTROLS | Immunodiagnostics, Ltd. | Sep 1, 1987 | SESE |
Top Applicants
- Aesku Diagnostics — 2 clearances
- Phadia US, Inc. — 1 clearance
- Inova Diagnostics, Inc. — 1 clearance
- Immunodiagnostics, Ltd. — 1 clearance
- Immco Diagnostics, Inc. — 1 clearance
