LJM · Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Immunology · 21 CFR 866.5100 · Class 2
Overview
| Product Code | LJM |
|---|---|
| Device Name | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls |
| 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 112)
Showing 20 most recent of 112 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K182353 | EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay | Phadia AB | Nov 27, 2018 | SESE |
| K151559 | ImmuLisa Enhanced Centromere Antibody ELISA | Immco Diagnostics, Inc. | Mar 11, 2016 | SESE |
| K140493 | ELIA SCL-70S IMMUNOASSAY | Phadia GmbH | Oct 30, 2014 | SESE |
| K123880 | QUANTA FLASH CENTROMERE | Inova Diagnostics, Inc. | Feb 7, 2014 | SESE |
| K131330 | GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT | Gold Standard Diagnostics | Jan 28, 2014 | SESE |
| K131185 | ANA SCREEN ELISA (IGG) | Euroimmun US | Jul 15, 2013 | SESE |
| K083188 | VARELISA RECOMBI ANA SCREEN, MODEL 12 596 | Phadia US, Inc. | Mar 13, 2009 | SESE |
| K050967 | VARELISA RECOMBI CTD SCREEN, MODEL 13096 | Sweden Diagnostics (Germany) GmbH | Jun 28, 2005 | SESE |
| K050625 | VARELISA RECOMBI ANA PROFILE, MODEL 18496 | Sweden Diagnostics (Germany) GmbH | Apr 26, 2005 | SESE |
| K041102 | IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA | Immco Diagnostics, Inc. | Oct 26, 2004 | SESE |
| K040953 | AESKULISA ANA HEP-2 | Aesku, Inc. | Jun 23, 2004 | SESE |
| K040810 | VARELISA HISTONE ANTIBODIES, MODEL 16496 | Pharmacia Deutschland GmbH | May 14, 2004 | SESE |
| K040291 | EL-ANA PROFILES: ANTI-CHROMATIN | Theratest Laboratories, Inc. | Mar 11, 2004 | SESE |
| K040200 | MESACUP-2 TEST CENP-B | Rhigene, Inc. | Mar 4, 2004 | SESE |
| K030929 | ANA DETECT | Orgentec Diagnostika GmbH | May 2, 2003 | SESE |
| K024031 | THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERE | Theratest Laboratories, Inc. | Feb 6, 2003 | SESE |
| K022018 | RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560 | Rhigene, Inc. | Jul 5, 2002 | SESE |
| K004019 | ANA EIA DIAGNOSTIC TEST KIT | The Binding Site, Ltd. | Feb 15, 2001 | SESE |
| K003959 | QUANTA LITE CENTROMERE (CENP-A & CENP-B) ELISA | Inova Diagnostics, Inc. | Jan 22, 2001 | SESE |
| K002559 | EL-ANA PROFILES-2K1 | Theratest Laboratories, Inc. | Sep 12, 2000 | SESE |
Top Applicants
- Elias U.S.A., Inc. — 16 clearances
- Zeus Scientific, Inc. — 6 clearances
- Theratest Laboratories, Inc. — 6 clearances
- Biohytech International, Inc. — 6 clearances
- American Laboratory Products Co., Ltd. — 6 clearances
