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) → CFQ — Radioimmunoassay, Immunoglobulins (G, A, M)

# CFQ · Radioimmunoassay, Immunoglobulins (G, A, M)

_Immunology · 21 CFR 866.5510 · Class 2_

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

## Overview

- **Product Code:** CFQ
- **Device Name:** Radioimmunoassay, Immunoglobulins (G, A, M)
- **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 (12 of 12)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K981786](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFQ/K981786.md) | IGA MININEPH ANTISERUM | The Binding Site, Ltd. | Nov 24, 1999 | SESE |
| [K990552](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFQ/K990552.md) | IMMUNOGLOBULIN A TEST SYSTEM | Dade Behring, Inc. | Mar 25, 1999 | SESE |
| [K990551](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFQ/K990551.md) | IGG FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | Mar 25, 1999 | SESE |
| [K990553](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFQ/K990553.md) | IGM FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | Mar 22, 1999 | SESE |
| [K951055](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFQ/K951055.md) | OLYMPUS IGA IMMUNOTURBIDIMETRIC REAGENT | Olympus America, Inc. | Apr 17, 1995 | SESE |
| [K951013](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFQ/K951013.md) | OLYMPUS IGG IMMUNOTURBIDIMETRIC REAGENT | Olympus America, Inc. | Apr 17, 1995 | SESE |
| [K950900](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFQ/K950900.md) | OLYMPUS IGM IMMUNOTURBIDIMETRIC REAGENT | Olympus America, Inc. | Mar 27, 1995 | SESE |
| [K891188](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFQ/K891188.md) | TITAN GEL IFE TRIVALENT ANTISERUM | Helena Laboratories | Mar 22, 1989 | SESE |
| [K890561](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFQ/K890561.md) | SPQ(TM) ANTIBODY REAGENT SET II FOR IGM | Atlantic Antibodies | Feb 23, 1989 | SESE |
| [K881928](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFQ/K881928.md) | MONOCLONAL RADIAL IMMUNODIFFUSION KIT | The Binding Site, Ltd. | Jul 8, 1988 | SESE |
| [K881827](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFQ/K881827.md) | IMMUNOGLOBULIN A TEST SYSTEM | The Binding Site, Ltd. | Jun 10, 1988 | SESE |
| [K881828](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CFQ/K881828.md) | IMMUNOGLOBULIN M TEST SYSTEM | The Binding Site, Ltd. | Jun 6, 1988 | SESE |

## Top Applicants

- The Binding Site, Ltd. — 4 clearances
- Olympus America, Inc. — 3 clearances
- Dade Behring, Inc. — 3 clearances
- Helena Laboratories — 1 clearance
- Atlantic Antibodies — 1 clearance

---

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

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