System, Test, Systemic Lupus Erythematosus
The Systemic Lupus Erythematosus (SLE) Test System is a diagnostic test used to detect autoantibodies associated with systemic lupus erythematosus, an autoimmune disorder affecting multiple organ systems. It is classified as FDA Class 2, a moderate-risk designation requiring 510(k) premarket notification, and is regulated under 21 CFR 866.5820 within the Immunology specialty. The device qualifies for third-party 510(k) review by an FDA-accredited organization.
Basic Information
- Product Code
- DHC
- Device Class
- FDA class 2
- Regulation Number
- 866.5820
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 16 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K001352 | REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT | Apr 09, 2001 | Substantially Equivalent | Corgenix, Inc. |
| K001398 | REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT | Mar 30, 2001 | Substantially Equivalent | Corgenix, Inc. |
| K930421 | ELIAS DSDNA ABS | Mar 10, 1993 | Substantially Equivalent | Elias U.S.A., Inc. |
| K930247 | HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE | Mar 10, 1993 | Substantially Equivalent | The Binding Site, Ltd. |
| K914801 | IMMUNOWELL DSDNA ANTIBODY TEST | Dec 09, 1991 | Substantially Equivalent | General Biometrics, Inc. |
| K885048 | ACCESS R-CLONE ANA PROFILE ASSAY | Jan 24, 1989 | Substantially Equivalent | Lipogen, Inc. |
| K872910 | IMMUNO/SLE | Aug 12, 1987 | Substantially Equivalent | Immunostics Co., Inc. |
| K821385 | SERO/TEX LE TEST | May 28, 1982 | Substantially Equivalent | Texas Immunology, Inc. |
| K810981 | ANTI NDNA IMMUNOFLOURESCENT TEST SYS | Apr 29, 1981 | Substantially Equivalent | Immuno-Products Industries |
| K810226 | SLE ANTI-N-DNA LATEX TEST | Feb 09, 1981 | Substantially Equivalent | Icl Scientific |
| K800992 | CORDIA NP | May 08, 1980 | Substantially Equivalent | Cordis Corp. |
| K800991 | CORDIA N | May 08, 1980 | Substantially Equivalent | Cordis Corp. |
| K800605 | ANA LATEX SLIDE TEST | Apr 02, 1980 | Substantially Equivalent | Biologics Intl., Inc. |
| K790257 | SYSTEMIC LUPUS | Mar 15, 1979 | Substantially Equivalent | Icl Scientific |
| K790106 | IIF-A-N-DNA TEST KIT | Mar 15, 1979 | Substantially Equivalent | Medica Corp. |
| K782129 | LUPO-TEC | Mar 12, 1979 | Substantially Equivalent | Armkel, LLC |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.