Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5700](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5700) → DGR — Whole Human Serum, Antigen, Antiserum, Control

# DGR · Whole Human Serum, Antigen, Antiserum, Control

_Immunology · 21 CFR 866.5700 · Class 1_

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

## Overview

- **Product Code:** DGR
- **Device Name:** Whole Human Serum, Antigen, Antiserum, Control
- **Regulation:** [21 CFR 866.5700](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5700)
- **Device Class:** 1
- **Review Panel:** [Immunology](/submissions/IM)

## Identification

A whole human plasma or serum immunological test system is a device that consists of reagents used to measure by immunochemical techniques the proteins in plasma or serum. Measurements of proteins in plasma or serum aid in the diagnosis of any disease concerned with abnormal levels of plasma or serum proteins, e.g., agammaglobulinemia, allergies, multiple myeloma, rheumatoid vasculitis, or hereditary angioneurotic edema.

## 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 (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K961544](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGR/K961544.md) | QUALITROL IGAME CONTROLS, LEVELS 1 AND 2 | Consolidated Technologies, Inc. | Sep 24, 1996 | SESE |
| [K902220](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGR/K902220.md) | PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. CONTROL | Boehringer Mannheim Corp. | Sep 5, 1990 | SESE |
| [K865014](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGR/K865014.md) | LIQUICHEK IMMUNOLOGY CONTROL (HUMAN) LEVELS I & II | Bio-Rad | Jan 9, 1987 | SESE |
| [K790298](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGR/K790298.md) | RADIOASSAY, CONTROL SERUM I, II, III | Kallestad Laboratories, Inc. | Apr 4, 1979 | SESE |
| [K781355](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DGR/K781355.md) | ICS NORMAL CONTROL SERUM | Beckman Instruments, Inc. | Aug 31, 1978 | SESE |

## Top Applicants

- Kallestad Laboratories, Inc. — 1 clearance
- Consolidated Technologies, Inc. — 1 clearance
- Boehringer Mannheim Corp. — 1 clearance
- Bio-Rad — 1 clearance
- Beckman Instruments, Inc. — 1 clearance

---

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

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com