LKO · Anti-Rnp Antibody, Antigen And Control
Immunology · 21 CFR 866.5100 · Class 2
Overview
| Product Code | LKO |
|---|---|
| Device Name | Anti-Rnp 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 (20 of 23)
Showing 20 most recent of 23 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K191085 | Maverick RNP Assay and Maverick Diagnostic System | Genalyte, Inc. | Oct 25, 2019 | SESE |
| K140224 | EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG) | Euroimmun US | Dec 9, 2014 | SESE |
| K123261 | EUROIMMUN ANTI-NRNP/SM ELISA (IGG) | Euroimmun US | Jun 12, 2013 | SESE |
| K083117 | ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01 | Phadia US, Inc. | May 28, 2009 | SESE |
| K071210 | MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006 | Biomedical Diagnostics (Bmd) SA | Dec 19, 2007 | SESE |
| K022017 | RHIGENE MESACUP-2 TEST RNP, MODEL M7741 | Rhigene, Inc. | Aug 14, 2002 | SESE |
| K000752 | RHIGENE MESACUP2 TEST- RNP | Rhigene, Inc. | May 9, 2000 | SESE |
| K993589 | VARELISA RNP ANTIBODIES | Pharmacia & Upjohn Co. | Nov 26, 1999 | SESE |
| K990624 | AUTOSTAT II ANTI-SM/RNP ELISA | Cogent Diagnotics , Ltd. | Apr 28, 1999 | SESE |
| K984476 | LIQUICHEK ANTI-RNP CONTROL, EIA, MODEL 207 | Bio-Rad | Dec 22, 1998 | SESE |
| K983465 | THE APTUS (AUTOMATED) APPLICATION OF THE SM/RNP ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE | Zeus Scientific, Inc. | Nov 18, 1998 | SESE |
| K954831 | ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY | Orgentec | May 8, 1996 | SESE |
| K954897 | HYTEC AUTOIMMUNE KITS (RNP) | Hycor Biomedical, Inc. | Mar 22, 1996 | SESE |
| K940588 | ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KIT | Helix Diagnostics, Inc. | Apr 20, 1994 | SESE |
| K930142 | SYNELISA U1-SNRNP (68KDA)-ANTIBODIES | Elias U.S.A., Inc. | May 11, 1993 | SESE |
| K911850 | IMMUNWELL SJOGREN`S SYNDROME B (LA) ANTIBODY TEST | General Biometrics, Inc. | May 7, 1991 | SESE |
| K911849 | IMMUNOWELL SJOGRENS SYNDROME A (RO)ANTIBODY TEST | General Biometrics, Inc. | May 7, 1991 | SESE |
| K905194 | DIASTAT ANTI-RO (SS-A) | Shield Diagnostics, Ltd. | Dec 13, 1990 | SESE |
| K905193 | DIASTAT ANTI-LA (SS-B) | Shield Diagnostics, Ltd. | Dec 13, 1990 | SESE |
| K895997 | RHEUMELISA ASSAY FOR RNP AUTOANTIBODIES | Lipogen, Inc. | Nov 6, 1989 | SESE |
Top Applicants
- Shield Diagnostics, Ltd. — 2 clearances
- Rhigene, Inc. — 2 clearances
- Lipogen, Inc. — 2 clearances
- General Biometrics, Inc. — 2 clearances
- Euroimmun US — 2 clearances
