LKJ · Antinuclear Antibody, Antigen, Control
Immunology · 21 CFR 866.5100 · Class 2
Overview
| Product Code | LKJ |
|---|---|
| Device Name | Antinuclear Antibody, Antigen, 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 (20 of 50)
Showing 20 most recent of 50 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K210902 | EliA Ro52, EliA Ro60 | Phadia AB | Jul 27, 2022 | SESE |
| K113610 | ANA-SCREEN WITH MDSS | Bio-Rad Laboratories | Jul 9, 2012 | SESE |
| K082759 | ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY | Phadia US, Inc. | Apr 10, 2009 | SESE |
| K081104 | AESKULISA ANA HEP-2, REF 30-7115US | Aesku Diagnostics | May 2, 2008 | SESE |
| K041658 | BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200 | Bio-Rad Laboratories, Inc. | Dec 20, 2004 | SESE |
| K042416 | ATHENA MULTI-LYTE ANA-II TEST SYSTEM | Zeus Scientific, Inc. | Oct 8, 2004 | SESE |
| K034013 | REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001 | Corgenix, Inc. | Jan 8, 2004 | SESE |
| K030775 | AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM | Immuno Concepts, N.A. , Ltd. | May 12, 2003 | SESE |
| K024232 | LIQUICHEK ANTI-SS-B CONTROL, POSITIVE, CATALOG #113 | Bio-Rad | Jan 17, 2003 | SESE |
| K024218 | LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114 | Bio-Rad | Jan 17, 2003 | SESE |
| K024223 | LIQUICHEK ANTI-RNP CONTROL, POSITIVE, CATALOG #116 | Bio-Rad | Jan 13, 2003 | SESE |
| K024226 | LIQUICHEK ANTI-SCL-70 CONTROL, POSITIVE, CATALOG #116 | Bio-Rad | Jan 10, 2003 | SESE |
| K021257 | ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) | Diagnostic Products Corp. | Jun 3, 2002 | SESE |
| K021103 | MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST SYSTEM | Zeus Scientific, Inc. | Apr 24, 2002 | SESE |
| K011244 | ZEUS SCIENTIFIC, INC. ATHENA MULTI-LYTE ANA TEST SYSTEM | Zeus Scientific, Inc. | Dec 10, 2001 | SESE |
| K993294 | DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEM | Diamedix Corp. | Oct 25, 1999 | SESE |
| K984478 | LIQUICHEK ANTI-SS-B CONTROL, EIA, MODEL 210 | Bio-Rad | Dec 22, 1998 | SESE |
| K984475 | LIQUICHEK ANTI-SCL-70 CONTROL, EIA, MODEL 212 | Bio-Rad | Dec 22, 1998 | SESE |
| K984473 | LIQUICHEK ANA CONTROL, EIA SCREEN, MODEL 205 | Bio-Rad | Dec 22, 1998 | SESE |
| K984470 | LIQUICHEK ANTI-SS-A CONTROL, EIA, MODEL 209 | Bio-Rad | Dec 22, 1998 | SESE |
Top Applicants
- Bio-Rad — 9 clearances
- Zeus Scientific, Inc. — 3 clearances
- Elias U.S.A., Inc. — 3 clearances
- Shield Diagnostics, Ltd. — 2 clearances
- Immco Diagnostics, Inc. — 2 clearances
