Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5820](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5820) → DHC — System, Test, Systemic Lupus Erythematosus

# DHC · System, Test, Systemic Lupus Erythematosus

_Immunology · 21 CFR 866.5820 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHC

## Overview

- **Product Code:** DHC
- **Device Name:** System, Test, Systemic Lupus Erythematosus
- **Regulation:** [21 CFR 866.5820](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5820)
- **Device Class:** 2
- **Review Panel:** [Immunology](/submissions/IM)
- **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](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHC/K001352.md) | REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT | Corgenix, Inc. | Apr 9, 2001 | SESE |
| [K001398](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHC/K001398.md) | REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT | Corgenix, Inc. | Mar 30, 2001 | SESE |
| [K930421](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHC/K930421.md) | ELIAS DSDNA ABS | Elias U.S.A., Inc. | Mar 10, 1993 | SESE |
| [K930247](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHC/K930247.md) | HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE | The Binding Site, Ltd. | Mar 10, 1993 | SESE |
| [K914801](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHC/K914801.md) | IMMUNOWELL DSDNA ANTIBODY TEST | General Biometrics, Inc. | Dec 9, 1991 | SESE |
| [K885048](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHC/K885048.md) | ACCESS R-CLONE ANA PROFILE ASSAY | Lipogen, Inc. | Jan 24, 1989 | SESE |
| [K872910](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHC/K872910.md) | IMMUNO/SLE | Immunostics Co., Inc. | Aug 12, 1987 | SESE |
| [K821385](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHC/K821385.md) | SERO/TEX LE TEST | Texas Immunology, Inc. | May 28, 1982 | SESE |
| [K810981](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHC/K810981.md) | ANTI NDNA IMMUNOFLOURESCENT TEST SYS | Immuno-Products Industries | Apr 29, 1981 | SESE |
| [K810226](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHC/K810226.md) | SLE ANTI-N-DNA LATEX TEST | Icl Scientific | Feb 9, 1981 | SESE |
| [K800992](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHC/K800992.md) | CORDIA NP | Cordis Corp. | May 8, 1980 | SESE |
| [K800991](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHC/K800991.md) | CORDIA N | Cordis Corp. | May 8, 1980 | SESE |
| [K800605](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHC/K800605.md) | ANA LATEX SLIDE TEST | Biologics Intl., Inc. | Apr 2, 1980 | SESE |
| [K790257](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHC/K790257.md) | SYSTEMIC LUPUS | Icl Scientific | Mar 15, 1979 | SESE |
| [K790106](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHC/K790106.md) | IIF-A-N-DNA TEST KIT | Medica Corp. | Mar 15, 1979 | SESE |
| [K782129](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHC/K782129.md) | 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

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHC](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHC)

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