Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5520](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5520) → DCE — Fab, Antigen, Antiserum, Control

# DCE · Fab, Antigen, Antiserum, Control

_Immunology · 21 CFR 866.5520 · Class 1_

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

## Overview

- **Product Code:** DCE
- **Device Name:** Fab, Antigen, Antiserum, Control
- **Regulation:** [21 CFR 866.5520](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5520)
- **Device Class:** 1
- **Review Panel:** [Immunology](/submissions/IM)

## Identification

An immunoglobulin G (Fab fragment specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the Fab antigen-binding fragment resulting from breakdown of immunoglobulin G antibodies in urine, serum, and other body fluids. Measurement of Fab fragments of immunoglobulin G aids in the diagnosis of lymphoproliferative disorders, such as multiple myeloma (tumor of bone marrow cells), Waldenstrom's macroglobulinemia (increased immunoglobulin production by the spleen and bone marrow cells), and lymphoma (tumor of the lymphoid tissues).

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K781951](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCE/K781951.md) | ANTISERA, RHODAMINE CONJUGATED FRAGMENT | Kallestad Laboratories, Inc. | Feb 16, 1979 | SESE |
| [K772128](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCE/K772128.md) | FLUORESCEIN CONJUGATED | Kallestad Laboratories, Inc. | Nov 22, 1977 | SESE |

## Top Applicants

- Kallestad Laboratories, Inc. — 2 clearances

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

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