Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5510](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5510) → JHR — Radioimmunoassay, Immunoglobulins (D, E)

# JHR · Radioimmunoassay, Immunoglobulins (D, E)

_Immunology · 21 CFR 866.5510 · Class 2_

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

## Overview

- **Product Code:** JHR
- **Device Name:** Radioimmunoassay, Immunoglobulins (D, E)
- **Regulation:** [21 CFR 866.5510](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5510)
- **Device Class:** 2
- **Review Panel:** [Immunology](/submissions/IM)
- **3rd-party reviewable:** yes

## Identification

An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (9 of 9)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K061970](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JHR/K061970.md) | ELECSYS IGE II IMMUNOASSAY | Roche Diagnostics | Aug 31, 2006 | SESE |
| [K984326](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JHR/K984326.md) | ELECYS IGE ASSAY | Boehringer Mannheim Corp. | Feb 8, 1999 | SESE |
| [K960067](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JHR/K960067.md) | IMMILITE TOTAL IGE | Diagnostic Products Corp. | Feb 14, 1996 | SESE |
| [K931703](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JHR/K931703.md) | IMMULITE TOTAL IGE | Diagnostic Products Corp. | Aug 16, 1993 | SESE |
| [K903000](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JHR/K903000.md) | TURBO-RAST SPECIFIC IGE ASSAY | Ventrex Laboratories, Inc. | Jul 31, 1990 | SESE |
| [K901859](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JHR/K901859.md) | COAT-A-COUNT TOTAL IGE IRMA, CATALOG #IKIE1, IKIE2 | Diagnostic Products Corp. | May 3, 1990 | SESE |
| [K882616](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JHR/K882616.md) | ALTERNATE PROCEDURE, PHARMACIA IGE EIA | Pharmacia, Inc. | Aug 4, 1988 | SESE |
| [K873077](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JHR/K873077.md) | PHARMACIA IGE EIA | Pharmacia, Inc. | Oct 20, 1987 | SESE |
| [K840103](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/JHR/K840103.md) | RADIOIMMUNOASSAY FOR TOTAL IGE HUMAN | Techniclone Intl. | Feb 10, 1984 | SESE |

## Top Applicants

- Diagnostic Products Corp. — 3 clearances
- Pharmacia, Inc. — 2 clearances
- Ventrex Laboratories, Inc. — 1 clearance
- Techniclone Intl. — 1 clearance
- Roche Diagnostics — 1 clearance

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

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