DHC · System, Test, Systemic Lupus Erythematosus
Immunology · 21 CFR 866.5820 · Class 2
Overview
| Product Code | DHC |
|---|---|
| Device Name | System, Test, Systemic Lupus Erythematosus |
| Regulation | 21 CFR 866.5820 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
Identification
A systemic lupus erythematosus (SLE) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum and other body fluids that react with cellular nuclear double-stranded deoxyribonucleic acid (DNA) or other nuclear constituents that are specifically diagnostic of SLE. Measurement of nuclear double-stranded DNA antibodies aids in the diagnosis of SLE (a multisystem autoimmune disease in which tissues are attacked by the person's own antibodies).
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (16 of 16)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K001352 | REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT | Corgenix, Inc. | Apr 9, 2001 | SESE |
| K001398 | REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT | Corgenix, Inc. | Mar 30, 2001 | SESE |
| K930421 | ELIAS DSDNA ABS | Elias U.S.A., Inc. | Mar 10, 1993 | SESE |
| K930247 | HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE | The Binding Site, Ltd. | Mar 10, 1993 | SESE |
| K914801 | IMMUNOWELL DSDNA ANTIBODY TEST | General Biometrics, Inc. | Dec 9, 1991 | SESE |
| K885048 | ACCESS R-CLONE ANA PROFILE ASSAY | Lipogen, Inc. | Jan 24, 1989 | SESE |
| K872910 | IMMUNO/SLE | Immunostics Co., Inc. | Aug 12, 1987 | SESE |
| K821385 | SERO/TEX LE TEST | Texas Immunology, Inc. | May 28, 1982 | SESE |
| K810981 | ANTI NDNA IMMUNOFLOURESCENT TEST SYS | Immuno-Products Industries | Apr 29, 1981 | SESE |
| K810226 | SLE ANTI-N-DNA LATEX TEST | Icl Scientific | Feb 9, 1981 | SESE |
| K800992 | CORDIA NP | Cordis Corp. | May 8, 1980 | SESE |
| K800991 | CORDIA N | Cordis Corp. | May 8, 1980 | SESE |
| K800605 | ANA LATEX SLIDE TEST | Biologics Intl., Inc. | Apr 2, 1980 | SESE |
| K790257 | SYSTEMIC LUPUS | Icl Scientific | Mar 15, 1979 | SESE |
| K790106 | IIF-A-N-DNA TEST KIT | Medica Corp. | Mar 15, 1979 | SESE |
| K782129 | LUPO-TEC | Armkel, LLC | Mar 12, 1979 | SESE |
Top Applicants
- Icl Scientific — 2 clearances
- Corgenix, Inc. — 2 clearances
- Cordis Corp. — 2 clearances
- The Binding Site, Ltd. — 1 clearance
- Texas Immunology, Inc. — 1 clearance
